<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02255838</url>
  </required_header>
  <id_info>
    <org_study_id>14.0689</org_study_id>
    <nct_id>NCT02255838</nct_id>
  </id_info>
  <brief_title>Evaluation of a Disposable Flexible Bronchoscope, aScope IV</brief_title>
  <acronym>EVAL</acronym>
  <official_title>Evaluation of a Disposable Flexible Bronchoscope, (aScope IV) a Randomized, Controlled, Cross-over Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Louisville</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Louisville</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Flexible bronchoscopes are typically reusable and therefore need high level disinfection to&#xD;
      prevent inadvertent spread of microbial pathogens from patient to patient. The process of&#xD;
      disinfection is time consuming and expensive. Moreover, a bronchoscope being processed may&#xD;
      not be readily available for another patient. One solution to this problem was to use a&#xD;
      single use disposable sheath that covers a flexible bronchoscope protecting all surfaces of&#xD;
      the bronchoscope.(Colt, Beamis, Harrell, &amp; Mathur, 2000). Another way to eliminate potential&#xD;
      hazards with a reusable bronchoscope is the use of a disposable bronchoscope. Such a&#xD;
      disposable bronchoscope has been developed (Ambu aScope, Ambu, Glen Burnie, MD) and has been&#xD;
      used successfully for intubations in manikins(Scutt et al., 2011) and patients. (Kristensen &amp;&#xD;
      Fredensborg, 2013; Pujol, López, &amp; Valero, 2010; Tvede, Kristensen, &amp; Nyhus-Andreasen, 2012).&#xD;
      Further advancement in the imaging and handling of this disposable flexible bronchoscope now&#xD;
      allows for the purpose of bronchoscopy and broncho-alveolar lavage in critically ill patients&#xD;
      with pulmonary compromise. (FDA approval: 05-11-2013 date)&#xD;
&#xD;
      The aim of the study is to compare image clarity, suction capacity, and handling performance&#xD;
      of a reusable flexible bronchoscope to the disposable flexible bronchoscope. In addition, the&#xD;
      investigators intend to perform a cost analysis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Description&#xD;
&#xD;
      Patients will be monitored by standard NIBP or invasive arterial lines, ECG and oxygen&#xD;
      saturation. All patients are intubated due to their respiratory insufficiency or for airway&#xD;
      protection. Patients will be anesthetized for the procedure. Anesthesia will be induced with&#xD;
      versed 2mg, fentanyl 100 µg and paralyzed with 0.1mg/kg vecuronium. Anesthesia will be&#xD;
      maintained with propofol infusion 50-150 µg/kg/min.&#xD;
&#xD;
      Study Procedures All patients will be under general anesthesia. Standard monitoring will be&#xD;
      applied. This includes a blood pressure cuff or an arterial line, EKG and a pulse-oximeter.&#xD;
      Patients will receive 2 mg/kg propofol, 1µg/kg fentanyl and 0.1mg/kg vecuronium for the&#xD;
      procedure. After induction of anesthesia the FiO2 will be turned to 1.0 and a bronchoscopy&#xD;
      adaptor will be interposed in the breathing circuit next to the endotracheal tube. Patients&#xD;
      will be randomized to receiving either the non-disposable bronchoscope (Storz 8402 2x, El&#xD;
      Segundo, CA) or the single use aScope 3 first. After randomization, bronchoscopy will be&#xD;
      started with an inspection of the trachea and carina. Next the right lung bronchial tree will&#xD;
      be inspected systematically beginning with the right upper lobe, following with the right&#xD;
      middle lobe and finishing with the right lower lobe. All segmental bronchi will be inspected&#xD;
      and cleaned by suction as deemed necessary. The bronchoscope will then be removed from the&#xD;
      bronchial tree and rinsed with saline Subsequently, the bronchoscope will be re-inserted and&#xD;
      advanced to the basal segmental bronchi of the right lower lobe. The tip of the bronchoscope&#xD;
      will be brought into wedge position in one of the basal segments for broncho-alveolar lavage&#xD;
      (BAL). A saline flush of 20 ml will be administered. The flow of saline will be observed at&#xD;
      the distal tip of the bronchoscope. After 10 seconds of maintaining a wedge position, gentle&#xD;
      suction will be applied to collect the lavage specimen in the collection trap. This step will&#xD;
      be repeated 4 more times (total of 80ml) to obtain an adequate specimen. The same procedure&#xD;
      will be repeated on the left lung using the alternate bronchoscope according to&#xD;
      randomization. At the end of the procedure, a chest radiograph will be obtained to rule out&#xD;
      pneumothorax.&#xD;
&#xD;
      Measurements&#xD;
&#xD;
      Before starting the procedure the set up time of each bronchoscope will be recorded. The&#xD;
      view, image, and light of each bronchoscope will be assessed, then the inspection of the&#xD;
      upper lobe segmental bronchi will be conducted. The time of lavage and suctioning until no&#xD;
      more specimen can be collected will be measured. The volume of the obtained specimen will be&#xD;
      measured. The specimen will be evaluated by a blinded observer after the procedure is&#xD;
      completed.(clear fluids, mucous secretions, viscous secretions, pus, blood etc). The blinded&#xD;
      observer will evaluate the quality and quanity of the sample for obtaining cultures.The&#xD;
      blinded observer will be an attending or resident from the infectious disease department.&#xD;
&#xD;
      The overall ease of handling will be rated directly after the procedure by the investigator.&#xD;
      All bronchoscopies will be taped and view-clarity, image and light-brightness will be&#xD;
      assessed by a second blinded observer. This blinder observer can be another investigator not&#xD;
      present during the procedure or an internist who was not present and is part of the study&#xD;
      team.&#xD;
&#xD;
      All assessments will be performed using a VAS scale of 0 to 10 cm as shown below. The&#xD;
      investigator will mark directly on the scale.&#xD;
&#xD;
      We will only enroll patients who were admitted to a critical care unit at the University of&#xD;
      Louisville and who are intubated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    slow enrollment, outdated material&#xD;
  </why_stopped>
  <start_date type="Actual">April 1, 2015</start_date>
  <completion_date type="Actual">January 14, 2020</completion_date>
  <primary_completion_date type="Actual">January 14, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <intervention_model_description>The disposable aScope IV bronchoscope will be compared to the re-usable bronchoscope</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>A blinded investigator will view the bronchoscopy video and evaluate. The blinded investigator will use the same criteria the investigator who did the procedure used (Un-blinded) for the evaluation. Video will not indicate which scope was used and only indicate if it is the right or left lung they are viewing. Research coordinator will keep separate a file indicating which scope was used.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluation of Visualization of Two Different Flexible Bronchoscopes; a Disposable and a Reusable Bronchoscope</measure>
    <time_frame>10 to 30 minutes</time_frame>
    <description>Visualization of the two bronchoscopes was measured by using a qualitative scale from 0 to 10; 0 being classified as &quot;cannot be evaluated&quot; and 10 being assessed as optimal visualization</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluation of the Handling of Two Different Flexible Bronchoscopes, a Disposable and a Reusable Bronchoscope</measure>
    <time_frame>10-30 minutes</time_frame>
    <description>Handling of the two bronchoscopes using a qualitative scale from 0 to 10; 0 being classified as &quot;cannot be evaluated&quot; and 10 being assessed as optimal visualization</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluation of Ability to Suction With Two Different Flexible Bronchoscopes, a Disposable and a Reusable Bronchoscope</measure>
    <time_frame>10-30 minutes</time_frame>
    <description>Measured suction capability by volume retrieved after broncho-alveolar lavage with 10 ml of saline, measured in ml</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of Flexibility of Two Different Flexible Bronchoscopes, a Disposable and a Reusable Bronchoscope</measure>
    <time_frame>10-30 minutes</time_frame>
    <description>Flexibility of the two bronchoscopes was measured by using a qualitative scale from 0 to 10; 0 being classified as &quot;cannot be evaluated&quot; and 10 being assessed as optimal flexibility</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Respiratory Insufficiency</condition>
  <condition>Pneumonia</condition>
  <condition>Atelectasis</condition>
  <arm_group>
    <arm_group_label>Disposable bronchoscope first (aScope IV), then Reusable bronchoscope (Storz 8402 2x)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>the bronchoscope will be re-inserted and advanced to the basal segmental bronchi of the right lower lobe. The tip of the bronchoscope will be brought into wedge position in one of the basal segments for broncho-alveolar lavage (BAL). A saline flush of 20 ml will be administered. The flow of saline will be observed at the distal tip of the bronchoscope. After 10 seconds of maintaining a wedge position, gentle suction will be applied to collect the lavage specimen in the collection trap. This step will be repeated 4 more times (total of 80ml) to obtain an adequate specimen.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Reusable bronchoscope first (Storz 8402 2x), then Disposable bronchoscope (aScope IV)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>the bronchoscope will be re-inserted and advanced to the basal segmental bronchi of the right lower lobe. The tip of the bronchoscope will be brought into wedge position in one of the basal segments for broncho-alveolar lavage (BAL). A saline flush of 20 ml will be administered. The flow of saline will be observed at the distal tip of the bronchoscope. After 10 seconds of maintaining a wedge position, gentle suction will be applied to collect the lavage specimen in the collection trap. This step will be repeated 4 more times (total of 80ml) to obtain an adequate specimen.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Bronchoscope reusable (Storz 8402 2x)</intervention_name>
    <description>Bronchoscopy and alveolar lavage</description>
    <arm_group_label>Reusable bronchoscope first (Storz 8402 2x), then Disposable bronchoscope (aScope IV)</arm_group_label>
    <other_name>Storz 8402 2x (Storz, El Segundo, CA)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Bronchoscope disposable (aScope 4)</intervention_name>
    <description>Bronchoscopy and alveolar lavage</description>
    <arm_group_label>Disposable bronchoscope first (aScope IV), then Reusable bronchoscope (Storz 8402 2x)</arm_group_label>
    <other_name>aScope 4 (Ambu, Glen Burnie, MD)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Adult 18 years old and older&#xD;
&#xD;
          2. Capable of giving informed consent or have an acceptable surrogate capable of giving&#xD;
             legally authorized consent on the subject's behalf.&#xD;
&#xD;
          3. Indication of a diagnostic and or therapeutic bronchoscopy as determined by the&#xD;
             attending critical care physician&#xD;
&#xD;
          4. Being cared for in the critical care units at the U of L Hospital&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1) Patient is moribund and a bronchoscopy is very unlikely to reduce impending mortality or&#xD;
        can avert death&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rainer Lenhardt, MD MBA</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Louisville School of Medicine Department of Anesthesiology and Perioperative Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Louisville School of Medicine</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Bellomo R, Tai E, Parkin G. Fibreoptic bronchoscopy in the critically ill: a prospective study of its diagnostic and therapeutic value. Anaesth Intensive Care. 1992 Nov;20(4):464-9. doi: 10.1177/0310057X9202000412.</citation>
    <PMID>1463174</PMID>
  </reference>
  <reference>
    <citation>Colt HG, Beamis JJ, Harrell JH, Mathur PM. Novel flexible bronchoscope and single-use disposable-sheath endoscope system. A preliminary technology evaluation. Chest. 2000 Jul;118(1):183-7. doi: 10.1378/chest.118.1.183.</citation>
    <PMID>10893377</PMID>
  </reference>
  <reference>
    <citation>Estella A. [Analysis of 208 flexible bronchoscopies performed in an intensive care unit]. Med Intensiva. 2012 Aug-Sep;36(6):396-401. doi: 10.1016/j.medin.2011.11.005. Epub 2011 Dec 20. Spanish.</citation>
    <PMID>22192316</PMID>
  </reference>
  <reference>
    <citation>Facciolongo N, Patelli M, Gasparini S, Lazzari Agli L, Salio M, Simonassi C, Del Prato B, Zanoni P. Incidence of complications in bronchoscopy. Multicentre prospective study of 20,986 bronchoscopies. Monaldi Arch Chest Dis. 2009 Mar;71(1):8-14. doi: 10.4081/monaldi.2009.370.</citation>
    <PMID>19522159</PMID>
  </reference>
  <reference>
    <citation>Georgiades G, Myrianthefs P, Venetsanou K, Kythreoti A, Kyroudi A, Kittas C, Baltopoulos G. Temperature and serum proinflammatory cytokine changes in patients with NSCLC after BAL. Lung. 2003;181(1):35-47. doi: 10.1007/s00408-003-1001-6.</citation>
    <PMID>12879338</PMID>
  </reference>
  <reference>
    <citation>Huang YC, Bassett MA, Levin D, Montilla T, Ghio AJ. Acute phase reaction in healthy volunteers after bronchoscopy with lavage. Chest. 2006 Jun;129(6):1565-9. doi: 10.1378/chest.129.6.1565.</citation>
    <PMID>16778276</PMID>
  </reference>
  <reference>
    <citation>Ikeda S, Yanai N, Ishikawa S. Flexible bronchofiberscope. Keio J Med. 1968 Mar;17(1):1-16. doi: 10.2302/kjm.17.1. No abstract available.</citation>
    <PMID>5674435</PMID>
  </reference>
  <reference>
    <citation>Kreider ME, Lipson DA. Bronchoscopy for atelectasis in the ICU: a case report and review of the literature. Chest. 2003 Jul;124(1):344-50. doi: 10.1378/chest.124.1.344.</citation>
    <PMID>12853543</PMID>
  </reference>
  <reference>
    <citation>Kristensen MS, Fredensborg BB. The disposable Ambu aScope vs. a conventional flexible videoscope for awake intubation -- a randomised study. Acta Anaesthesiol Scand. 2013 Aug;57(7):888-95. doi: 10.1111/aas.12094. Epub 2013 Mar 15.</citation>
    <PMID>23495767</PMID>
  </reference>
  <reference>
    <citation>Lucena CM, Martinez-Olondris P, Badia JR, Xaubet A, Ferrer M, Torres A, Agusti C. [Fiberoptic bronchoscopy in a respiratory intensive care unit]. Med Intensiva. 2012 Aug-Sep;36(6):389-95. doi: 10.1016/j.medin.2011.11.004. Epub 2011 Dec 22. Spanish.</citation>
    <PMID>22195599</PMID>
  </reference>
  <reference>
    <citation>Perkins GD, Chatterjie S, McAuley DF, Gao F, Thickett DR. Role of nonbronchoscopic lavage for investigating alveolar inflammation and permeability in acute respiratory distress syndrome. Crit Care Med. 2006 Jan;34(1):57-64. doi: 10.1097/01.ccm.0000190197.69945.c5.</citation>
    <PMID>16374157</PMID>
  </reference>
  <reference>
    <citation>Pujol E, Lopez AM, Valero R. Use of the Ambu((R)) aScope in 10 patients with predicted difficult intubation. Anaesthesia. 2010 Oct;65(10):1037-40. doi: 10.1111/j.1365-2044.2010.06477.x.</citation>
    <PMID>20707786</PMID>
  </reference>
  <reference>
    <citation>Du Rand IA, Blaikley J, Booton R, Chaudhuri N, Gupta V, Khalid S, Mandal S, Martin J, Mills J, Navani N, Rahman NM, Wrightson JM, Munavvar M; British Thoracic Society Bronchoscopy Guideline Group. Summary of the British Thoracic Society guideline for diagnostic flexible bronchoscopy in adults. Thorax. 2013 Aug;68(8):786-7. doi: 10.1136/thoraxjnl-2013-203629.</citation>
    <PMID>23842821</PMID>
  </reference>
  <reference>
    <citation>Scutt S, Clark N, Cook TM, Smith C, Christmas T, Coppel L, Crewdson K. Evaluation of a single-use intubating videoscope (Ambu aScope ) in three airway training manikins for oral intubation, nasal intubation and intubation via three supraglottic airway devices. Anaesthesia. 2011 Apr;66(4):293-9. doi: 10.1111/j.1365-2044.2011.06647.x. Epub 2011 Feb 24.</citation>
    <PMID>21401543</PMID>
  </reference>
  <reference>
    <citation>Sharif-Kashani B, Shahabi P, Behzadnia N, Mohammad-Taheri Z, Mansouri D, Masjedi MR, Zargari L, Salimi Negad L. Incidence of fever and bacteriemia following flexible fiberoptic bronchoscopy: a prospective study. Acta Med Iran. 2010 Nov-Dec;48(6):385-8.</citation>
    <PMID>21287478</PMID>
  </reference>
  <reference>
    <citation>Steinberg KP, Mitchell DR, Maunder RJ, Milberg JA, Whitcomb ME, Hudson LD. Safety of bronchoalveolar lavage in patients with adult respiratory distress syndrome. Am Rev Respir Dis. 1993 Sep;148(3):556-61. doi: 10.1164/ajrccm/148.3.556.</citation>
    <PMID>8368623</PMID>
  </reference>
  <reference>
    <citation>Tsao TC, Tsai YH, Lan RS, Shieh WB, Lee CH. Treatment for collapsed lung in critically ill patients. Selective intrabronchial air insufflation using the fiberoptic bronchoscope. Chest. 1990 Feb;97(2):435-8. doi: 10.1378/chest.97.2.435.</citation>
    <PMID>2298070</PMID>
  </reference>
  <reference>
    <citation>Tvede MF, Kristensen MS, Nyhus-Andreasen M. A cost analysis of reusable and disposable flexible optical scopes for intubation. Acta Anaesthesiol Scand. 2012 May;56(5):577-84. doi: 10.1111/j.1399-6576.2012.02653.x. Epub 2012 Feb 16.</citation>
    <PMID>22338623</PMID>
  </reference>
  <reference>
    <citation>Um SW, Choi CM, Lee CT, Kim YW, Han SK, Shim YS, Yoo CG. Prospective analysis of clinical characteristics and risk factors of postbronchoscopy fever. Chest. 2004 Mar;125(3):945-52. doi: 10.1378/chest.125.3.945.</citation>
    <PMID>15006953</PMID>
  </reference>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>September 24, 2014</study_first_submitted>
  <study_first_submitted_qc>September 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2014</study_first_posted>
  <results_first_submitted>July 16, 2021</results_first_submitted>
  <results_first_submitted_qc>April 25, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">April 26, 2022</results_first_posted>
  <last_update_submitted>April 25, 2022</last_update_submitted>
  <last_update_submitted_qc>April 25, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 26, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Louisville</investigator_affiliation>
    <investigator_full_name>Rainer Lenhardt</investigator_full_name>
    <investigator_title>MD, MBA</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pulmonary Atelectasis</mesh_term>
    <mesh_term>Respiratory Insufficiency</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 27, 2014</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/38/NCT02255838/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 8, 2014</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/38/NCT02255838/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>period August 8, 2015 to July 8, 2017 location: ICU</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Disposable Bronchoscope First (aScope IV), Then Reusable Bronchoscope (Storz 8402 2x)</title>
          <description>Randomly controlled, either the disposable bronchoscope (aScope 4) was inserted first into the trachea and advanced into the right lung. Subsequently, a reusable bronchoscope (Storz 8402) was inserted into the trachea and advanced into the left lung. If randomization assigned the reusable bronchoscope to be inserted first, then the reusable bronchoscope was inserted into the trachea and advanced into the right lung first followed by insertion of the disposable bronchoscope and advancement into the left lung. The subsequent procedure was identical for both parts of this crossover trial and is described as follows: After insertion of the bronchoscope into the bronchial tree the scope was advanced to the basal segmental bronchi of the right or left lower lobe. The tip of the bronchoscope was brought into wedge position in one of the basal segments for broncho-alveolar lavage (BAL). A saline flush of 20 ml was administered. The flow of saline was observed at the distal tip of the bronchoscope. After 10 seconds of maintaining a wedge position, gentle suction was applied to collect the lavage specimen in the collection trap. This step was repeated 4 more times (total of 80 ml) to obtain an adequate specimen.</description>
        </group>
        <group group_id="P2">
          <title>Reusable Bronchoscope First (Storz 8402 2x), Then Disposable Bronchoscope (aScope IV)</title>
          <description>Randomly controlled, either the reusable bronchoscope (Storz 8402) was inserted first into the trachea and advanced into the right lung. Subsequently, disposable bronchoscope (aScope 4) was inserted into the trachea and advanced into the left lung. If randomization assigned the reusable bronchoscope to be inserted first, then the reusable bronchoscope was inserted into the trachea and advanced into the right lung first followed by insertion of the disposable bronchoscope and advancement into the left lung. The subsequent procedure was identical for both parts of this crossover trial and is described as follows: After insertion of the bronchoscope into the bronchial tree the scope was advanced to the basal segmental bronchi of the right or left lower lobe. The tip of the bronchoscope was brought into wedge position in one of the basal segments for broncho-alveolar lavage (BAL). A saline flush of 20 ml was administered. The flow of saline was observed at the distal tip of the bronchoscope. After 10 seconds of maintaining a wedge position, gentle suction was applied to collect the lavage specimen in the collection trap. This step was repeated 4 more times (total of 80 ml) to obtain an adequate specimen.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>All participants were randomized to receive both intervention in a sequential order, per a cross-over study design</population>
      <group_list>
        <group group_id="B1">
          <title>Disposable Bronchoscope Insertion Followed by Reusable Bronchoscope Insertion or Vice Versa</title>
          <description>Randomly controlled, either the disposable bronchoscope (aScope 4) was inserted first into the trachea and advanced into the right lung. Subsequently, a reusable bronchoscope (Storz 8402) was inserted into the trachea and advanced into the left lung. If randomization assigned the reusable bronchoscope to be inserted first, then the reusable bronchoscope was inserted into the trachea and advanced into the right lung first followed by insertion of the disposable bronchoscope and advancement into the left lung. The subsequent procedure was identical for both parts of this crossover trial and is described as follows: After insertion of the bronchoscope into the bronchial tree the scope was advanced to the basal segmental bronchi of the right or left lower lobe. The tip of the bronchoscope was brought into wedge position in one of the basal segments for broncho-alveolar lavage (BAL). A saline flush of 20 ml was administered. The flow of saline was observed at the distal tip of the bronchoscope. After 10 seconds of maintaining a wedge position, gentle suction was applied to collect the lavage specimen in the collection trap. This step was repeated 4 more times (total of 80 ml) to obtain an adequate specimen.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="12"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="72" spread="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Evaluation of Visualization of Two Different Flexible Bronchoscopes; a Disposable and a Reusable Bronchoscope</title>
        <description>Visualization of the two bronchoscopes was measured by using a qualitative scale from 0 to 10; 0 being classified as &quot;cannot be evaluated&quot; and 10 being assessed as optimal visualization</description>
        <time_frame>10 to 30 minutes</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Bronchoscope Disposable, aScope IV</title>
            <description>Randomly controlled, the disposable bronchoscope (aScope 4) was inserted into the trachea and advanced into the right lung or the disposable bronchoscope was inserted as the second bronchoscope into the left lung.</description>
          </group>
          <group group_id="O2">
            <title>Reusable Bronchoscope (Storz 8402)</title>
            <description>Randomly controlled, the reusable bronchoscope (Storz 8402) was inserted into the trachea and advanced into the right lung or the reusable bronchoscope was inserted as the second bronchoscope into the left lung.</description>
          </group>
        </group_list>
        <measure>
          <title>Evaluation of Visualization of Two Different Flexible Bronchoscopes; a Disposable and a Reusable Bronchoscope</title>
          <description>Visualization of the two bronchoscopes was measured by using a qualitative scale from 0 to 10; 0 being classified as &quot;cannot be evaluated&quot; and 10 being assessed as optimal visualization</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.5" spread="1.2"/>
                    <measurement group_id="O2" value="8.0" spread="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.05</p_value>
            <method>t-test, 2 sided</method>
            <method_desc>paired t-test</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Evaluation of the Handling of Two Different Flexible Bronchoscopes, a Disposable and a Reusable Bronchoscope</title>
        <description>Handling of the two bronchoscopes using a qualitative scale from 0 to 10; 0 being classified as &quot;cannot be evaluated&quot; and 10 being assessed as optimal visualization</description>
        <time_frame>10-30 minutes</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Bronchoscope Disposable, aScope IV</title>
            <description>Randomly controlled, the disposable bronchoscope (aScope 4) was inserted into the trachea and advanced into the right lung or the disposable bronchoscope was inserted as the second bronchoscope into the left lung.</description>
          </group>
          <group group_id="O2">
            <title>Reusable Bronchoscope(Storz 8402)</title>
            <description>Randomly controlled, the reusable bronchoscope (Storz 8402) was inserted into the trachea and advanced into the right lung or the reusable bronchoscope was inserted as the second bronchoscope into the left lung.</description>
          </group>
        </group_list>
        <measure>
          <title>Evaluation of the Handling of Two Different Flexible Bronchoscopes, a Disposable and a Reusable Bronchoscope</title>
          <description>Handling of the two bronchoscopes using a qualitative scale from 0 to 10; 0 being classified as &quot;cannot be evaluated&quot; and 10 being assessed as optimal visualization</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.0" spread="1.5"/>
                    <measurement group_id="O2" value="8.0" spread="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Evaluation of Ability to Suction With Two Different Flexible Bronchoscopes, a Disposable and a Reusable Bronchoscope</title>
        <description>Measured suction capability by volume retrieved after broncho-alveolar lavage with 10 ml of saline, measured in ml</description>
        <time_frame>10-30 minutes</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Bronchoscope Disposable, aScope IV</title>
            <description>Randomly controlled, the disposable bronchoscope (aScope 4) was inserted into the trachea and advanced into the right lung or the disposable bronchoscope was inserted as the second bronchoscope into the left lung.</description>
          </group>
          <group group_id="O2">
            <title>Bronchoscope Reusable Storz 8402 2x</title>
            <description>Randomly controlled, the reusable bronchoscope (Storz 8402) was inserted into the trachea and advanced into the right lung or the reusable bronchoscope was inserted as the second bronchoscope into the left lung.</description>
          </group>
        </group_list>
        <measure>
          <title>Evaluation of Ability to Suction With Two Different Flexible Bronchoscopes, a Disposable and a Reusable Bronchoscope</title>
          <description>Measured suction capability by volume retrieved after broncho-alveolar lavage with 10 ml of saline, measured in ml</description>
          <units>milliliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.4" spread="0.9"/>
                    <measurement group_id="O2" value="5.3" spread="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Evaluation of Flexibility of Two Different Flexible Bronchoscopes, a Disposable and a Reusable Bronchoscope</title>
        <description>Flexibility of the two bronchoscopes was measured by using a qualitative scale from 0 to 10; 0 being classified as &quot;cannot be evaluated&quot; and 10 being assessed as optimal flexibility</description>
        <time_frame>10-30 minutes</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Bronchoscope Disposable, aScope IV</title>
            <description>Randomly controlled, the disposable bronchoscope (aScope 4) was inserted into the trachea and advanced into the right lung or the disposable bronchoscope was inserted as the second bronchoscope into the left lung.</description>
          </group>
          <group group_id="O2">
            <title>Bronchoscope Reusable Storz 8402 2x</title>
            <description>Randomly controlled, the reusable bronchoscope (Storz 8402) was inserted into the trachea and advanced into the right lung or the reusable bronchoscope was inserted as the second bronchoscope into the left lung.</description>
          </group>
        </group_list>
        <measure>
          <title>Evaluation of Flexibility of Two Different Flexible Bronchoscopes, a Disposable and a Reusable Bronchoscope</title>
          <description>Flexibility of the two bronchoscopes was measured by using a qualitative scale from 0 to 10; 0 being classified as &quot;cannot be evaluated&quot; and 10 being assessed as optimal flexibility</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.7" spread="10"/>
                    <measurement group_id="O2" value="7.4" spread="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>60 minutes</time_frame>
      <desc>routine bronchoscopies in the ICU, potential adverse events were observed during the study period of 10-30 minutes and for one hour after the bronchoscopy</desc>
      <group_list>
        <group group_id="E1">
          <title>Disposable Bronchoscope First (aScope IV), Then Reusable Bronchoscope (Storz 8402 2x)</title>
          <description>no adverse events</description>
        </group>
        <group group_id="E2">
          <title>Reusable Bronchoscope First (Storz 8402 2x), Then Disposable Bronchoscope (aScope IV)</title>
          <description>no adverse events</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Rainer Lenhardt</name_or_title>
      <organization>University of Louisville</organization>
      <phone>5028523122</phone>
      <email>rainer.lenhardt@louisville.edu</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02255838
org study id: 14.0689
nct id: NCT02255838
lead sponsor: 
has dmc: No
Flexible bronchoscopes are typically reusable and therefore need high level disinfection to
      prevent inadvertent spread of microbial pathogens from patient to patient. The process of
      disinfection is time consuming and expensive. Moreover, a bronchoscope being processed may
      not be readily available for another patient. One solution to this problem was to use a
      single use disposable sheath that covers a flexible bronchoscope protecting all surfaces of
      the bronchoscope.(Colt, Beamis, Harrell, & Mathur, 2000). Another way to eliminate potential
      hazards with a reusable bronchoscope is the use of a disposable bronchoscope. Such a
      disposable bronchoscope has been developed (Ambu aScope, Ambu, Glen Burnie, MD) and has been
      used successfully for intubations in manikins(Scutt et al., 2011) and patients. (Kristensen &
      Fredensborg, 2013; Pujol, López, & Valero, 2010; Tvede, Kristensen, & Nyhus-Andreasen, 2012).
      Further advancement in the imaging and handling of this disposable flexible bronchoscope now
      allows for the purpose of bronchoscopy and broncho-alveolar lavage in critically ill patients
      with pulmonary compromise. (FDA approval: 05-11-2013 date)

      The aim of the study is to compare image clarity, suction capacity, and handling performance
      of a reusable flexible bronchoscope to the disposable flexible bronchoscope. In addition, the
      investigators intend to perform a cost analysis.
Description

      Patients will be monitored by standard NIBP or invasive arterial lines, ECG and oxygen
      saturation. All patients are intubated due to their respiratory insufficiency or for airway
      protection. Patients will be anesthetized for the procedure. Anesthesia will be induced with
      versed 2mg, fentanyl 100 µg and paralyzed with 0.1mg/kg vecuronium. Anesthesia will be
      maintained with propofol infusion 50-150 µg/kg/min.

      Study Procedures All patients will be under general anesthesia. Standard monitoring will be
      applied. This includes a blood pressure cuff or an arterial line, EKG and a pulse-oximeter.
      Patients will receive 2 mg/kg propofol, 1µg/kg fentanyl and 0.1mg/kg vecuronium for the
      procedure. After induction of anesthesia the FiO2 will be turned to 1.0 and a bronchoscopy
      adaptor will be interposed in the breathing circuit next to the endotracheal tube. Patients
      will be randomized to receiving either the non-disposable bronchoscope (Storz 8402 2x, El
      Segundo, CA) or the single use aScope 3 first. After randomization, bronchoscopy will be
      started with an inspection of the trachea and carina. Next the right lung bronchial tree will
      be inspected systematically beginning with the right upper lobe, following with the right
      middle lobe and finishing with the right lower lobe. All segmental bronchi will be inspected
      and cleaned by suction as deemed necessary. The bronchoscope will then be removed from the
      bronchial tree and rinsed with saline Subsequently, the bronchoscope will be re-inserted and
      advanced to the basal segmental bronchi of the right lower lobe. The tip of the bronchoscope
      will be brought into wedge position in one of the basal segments for broncho-alveolar lavage
      (BAL). A saline flush of 20 ml will be administered. The flow of saline will be observed at
      the distal tip of the bronchoscope. After 10 seconds of maintaining a wedge position, gentle
      suction will be applied to collect the lavage specimen in the collection trap. This step will
      be repeated 4 more times (total of 80ml) to obtain an adequate specimen. The same procedure
      will be repeated on the left lung using the alternate bronchoscope according to
      randomization. At the end of the procedure, a chest radiograph will be obtained to rule out
      pneumothorax.

      Measurements

      Before starting the procedure the set up time of each bronchoscope will be recorded. The
      view, image, and light of each bronchoscope will be assessed, then the inspection of the
      upper lobe segmental bronchi will be conducted. The time of lavage and suctioning until no
      more specimen can be collected will be measured. The volume of the obtained specimen will be
      measured. The specimen will be evaluated by a blinded observer after the procedure is
      completed.(clear fluids, mucous secretions, viscous secretions, pus, blood etc). The blinded
      observer will evaluate the quality and quanity of the sample for obtaining cultures.The
      blinded observer will be an attending or resident from the infectious disease department.

      The overall ease of handling will be rated directly after the procedure by the investigator.
      All bronchoscopies will be taped and view-clarity, image and light-brightness will be
      assessed by a second blinded observer. This blinder observer can be another investigator not
      present during the procedure or an internist who was not present and is part of the study
      team.

      All assessments will be performed using a VAS scale of 0 to 10 cm as shown below. The
      investigator will mark directly on the scale.

      We will only enroll patients who were admitted to a critical care unit at the University of
      Louisville and who are intubated.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: The disposable aScope IV bronchoscope will be compared to the re-usable bronchoscope
primary purpose: Diagnostic
masking: None (Open Label)
masking description: A blinded investigator will view the bronchoscopy video and evaluate. The blinded investigator will use the same criteria the investigator who did the procedure used (Un-blinded) for the evaluation. Video will not indicate which scope was used and only indicate if it is the right or left lung they are viewing. Research coordinator will keep separate a file indicating which scope was used.
measure: Evaluation of Visualization of Two Different Flexible Bronchoscopes; a Disposable and a Reusable Bronchoscope
time frame: 10 to 30 minutes
description: Visualization of the two bronchoscopes was measured by using a qualitative scale from 0 to 10; 0 being classified as "cannot be evaluated" and 10 being assessed as optimal visualization
measure: Evaluation of the Handling of Two Different Flexible Bronchoscopes, a Disposable and a Reusable Bronchoscope
time frame: 10-30 minutes
description: Handling of the two bronchoscopes using a qualitative scale from 0 to 10; 0 being classified as "cannot be evaluated" and 10 being assessed as optimal visualization
measure: Evaluation of Ability to Suction With Two Different Flexible Bronchoscopes, a Disposable and a Reusable Bronchoscope
time frame: 10-30 minutes
description: Measured suction capability by volume retrieved after broncho-alveolar lavage with 10 ml of saline, measured in ml
measure: Evaluation of Flexibility of Two Different Flexible Bronchoscopes, a Disposable and a Reusable Bronchoscope
time frame: 10-30 minutes
description: Flexibility of the two bronchoscopes was measured by using a qualitative scale from 0 to 10; 0 being classified as "cannot be evaluated" and 10 being assessed as optimal flexibility
arm group label: Disposable bronchoscope first (aScope IV), then Reusable bronchoscope (Storz 8402 2x)
arm group type: Experimental
description: the bronchoscope will be re-inserted and advanced to the basal segmental bronchi of the right lower lobe. The tip of the bronchoscope will be brought into wedge position in one of the basal segments for broncho-alveolar lavage (BAL). A saline flush of 20 ml will be administered. The flow of saline will be observed at the distal tip of the bronchoscope. After 10 seconds of maintaining a wedge position, gentle suction will be applied to collect the lavage specimen in the collection trap. This step will be repeated 4 more times (total of 80ml) to obtain an adequate specimen.
arm group label: Reusable bronchoscope first (Storz 8402 2x), then Disposable bronchoscope (aScope IV)
arm group type: Active Comparator
description: the bronchoscope will be re-inserted and advanced to the basal segmental bronchi of the right lower lobe. The tip of the bronchoscope will be brought into wedge position in one of the basal segments for broncho-alveolar lavage (BAL). A saline flush of 20 ml will be administered. The flow of saline will be observed at the distal tip of the bronchoscope. After 10 seconds of maintaining a wedge position, gentle suction will be applied to collect the lavage specimen in the collection trap. This step will be repeated 4 more times (total of 80ml) to obtain an adequate specimen.
intervention type: Device
intervention name: Bronchoscope reusable (Storz 8402 2x)
description: Bronchoscopy and alveolar lavage
arm group label: Reusable bronchoscope first (Storz 8402 2x), then Disposable bronchoscope (aScope IV)
other name: Storz 8402 2x (Storz, El Segundo, CA)
intervention type: Device
intervention name: Bronchoscope disposable (aScope 4)
description: Bronchoscopy and alveolar lavage
arm group label: Disposable bronchoscope first (aScope IV), then Reusable bronchoscope (Storz 8402 2x)
other name: aScope 4 (Ambu, Glen Burnie, MD)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Rainer Lenhardt, MD MBA
role: Principal Investigator
affiliation: University of Louisville School of Medicine Department of Anesthesiology and Perioperative Medicine
facility: 
country: United States
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PMID: 1463174
citation: Colt HG, Beamis JJ, Harrell JH, Mathur PM. Novel flexible bronchoscope and single-use disposable-sheath endoscope system. A preliminary technology evaluation. Chest. 2000 Jul;118(1):183-7. doi: 10.1378/chest.118.1.183.
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responsible party type: Principal Investigator
investigator affiliation: University of Louisville
investigator full name: Rainer Lenhardt
investigator title: MD, MBA
mesh term: Pulmonary Atelectasis
mesh term: Respiratory Insufficiency
sharing ipd: No
provided document: 
provided document: 
participant flow: 
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outcome list: 
reported events: 
certain agreements: 
point of contact: 