<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/NCT03307018</url>
  </required_header>
  <id_info>
    <org_study_id>TH-17-BR-1</org_study_id>
    <nct_id>NCT03307018</nct_id>
  </id_info>
  <brief_title>Influence of Postoperative Bronchoscopy on Pulmonary Complications After Anatomical Lung Resections.</brief_title>
  <official_title>Assessment of Influence of Routine Postoperative Systematic Bronchial Aspiration With Flexible Bronchoscope on Occurrence of Pulmonary Complications After Anatomical Lung Resections: a Prospective Randomized Controlled Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wielkopolskie Centrum Pulmonologii i Torakochirurgii</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wielkopolskie Centrum Pulmonologii i Torakochirurgii</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Respiratory complications are the largest group of complications following anatomical lung&#xD;
      resections. Most of these complications result from a disrupted evacuation of respiratory&#xD;
      secretions. At present, prevention of such complications involve: aspirating of secretions&#xD;
      with a catheter during surgery through an intubation tube, active postoperative&#xD;
      rehabilitation, mucolytic treatment and effective postoperative pain management. Suctioning&#xD;
      of secretions by a catheter through an intubation tube does not, however, allow for removal&#xD;
      of secretions from entire bronchial tree. Bronchofiberoscopy with a small-diameter flexible&#xD;
      bronchoscope and thorough, systematic aspiration of secretions from respiratory tract&#xD;
      immediately after surgery could presumably result in more effective bronchial cleansing and&#xD;
      reduce risk of respiratory complications after surgery. Although the British Thoracic Society&#xD;
      guidelines do not recommend routine bronchoscopy as a standard postoperative management after&#xD;
      lung resections, they are based on a single, randomized, study analyzing a small group of&#xD;
      patients. Bronchoscopy with systematic aspiration of secretions done with a thin flexible&#xD;
      scope is a safe procedure, without risk of complications. It does not cause any additional&#xD;
      discomfort to the patients and allows for much more accurate aspiration of the bronchial&#xD;
      secretions than with a catheter inserted blindly through an intubation tube. It also gives an&#xD;
      opportunity to directly evaluate segmental and subsegmental bronchial patency. This is&#xD;
      particularly important in patients with COPD who tend to accumulate large amounts of mucus&#xD;
      secretion in the bronchial tree.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Introduction.&#xD;
&#xD;
      Atelectasis and pneumonia are the most common complications after anatomical lung resections.&#xD;
      Their occurrence in the postoperative period may necessitate treatment with antibiotics and&#xD;
      fiberoptic bronchoscopy and may lead prolongation of hospital stay, diminished quality of&#xD;
      life and increased cost of treatment.&#xD;
&#xD;
      Among known risk factors, retention of bronchial secretions is probably the most important.&#xD;
      Although at the end of surgery suctioning of the secretions from large airways is always&#xD;
      done, it is usually performed with suction catheter inserted blindly through an endotracheal&#xD;
      tube. This procedure does not allow for complete removal of secretions from all parts of&#xD;
      bronchial tree and trachea. Remaining secretions may lead to postoperative atelectasis and&#xD;
      pneumonia.&#xD;
&#xD;
      Fiberoptic bronchoscopy performed with a thin scope allows for accurate visual assessment and&#xD;
      precise aspiration of secretions from all main, lobar and segmental bronchi. If performed in&#xD;
      a systematic way, it allows for complete removal of bronchial secretions.&#xD;
&#xD;
      The role of routine bronchoscopic aspiration has already been evaluated in one randomized&#xD;
      study. However, study group included only 20 subjects, which is too little to perform proper&#xD;
      statistical analysis and draw conclusions (1).&#xD;
&#xD;
      Study design.&#xD;
&#xD;
      After qualification for the study informed consent will be obtained from a patient.&#xD;
&#xD;
      Patients will be randomly assigned to one of two arms of the study: &quot;BRONCH&quot; or &quot;CONTROL&quot;.&#xD;
      Simple randomization method and random number generator&#xD;
      (https://www.graphpad.com/quickcalcs/index.cfm) will be used.&#xD;
&#xD;
      Initial assessment will include demographics, smoking history, comorbidities (Charlson&#xD;
      Comorbidity Index, CCI and Thoracic Revised Cardiac Risk Index, thRCRI), pulmonary function&#xD;
      tests, diffusion lung capacity (DLCO), computed tomography of the chest and bronchoscopy.&#xD;
&#xD;
      Surgery will be performed under general anesthesia with double-lumen endotracheal tube&#xD;
      intubation and single lung ventilation. Patients will be placed in lateral decubitus position&#xD;
      and operation table will be flexed at the level of 5th - 6th rib The decision about the type&#xD;
      of surgical approach (video-assisted thoracic surgery, VATS or antero-lateral muscle-sparing&#xD;
      thoracotomy) will be made according to the criteria presently used, in particular size of a&#xD;
      tumor and its TNM classification assessed on the basis of preoperative studies.&#xD;
&#xD;
      Pulmonary lobectomy will be performed in standardized fashion. Pulmonary vessels (veins and&#xD;
      arteries) will be closed with vascular staplers, silk loops or vascular clips. Bronchus will&#xD;
      be closed with stapler or running suture. Interlobar fissures will be divided with staplers.&#xD;
      Mediastinal lymph node dissection (MLND) will be performed using either monopolar&#xD;
      electrocautery or high-energy device. One chest tube will be placed in case of VATS and two&#xD;
      in case of thoracotomy.&#xD;
&#xD;
      At the end of surgery, after lobectomy and MLND, catheter will be introduced through&#xD;
      intubation tube and suctioning of secretions from large airways will be done. Collapsed lung&#xD;
      will be re-expanded and alveolar recruitment maneuvers will be performed.&#xD;
&#xD;
      VATS/thoracotomy wound will be closed and patient will be placed in prone position. All&#xD;
      investigators, except one designated for performing bronchoscopy will leave operating room.&#xD;
&#xD;
      At this time, it will be checked, to which arm the patient was randomly assigned. If the&#xD;
      patient was assigned to &quot;CONTROL&quot; arm, bronchoscopy will not be done and the patient will be&#xD;
      woken. If the patient was assigned to &quot;BRONCH&quot; arm, bronchoscopy will be done.&#xD;
&#xD;
      Bronchoscope will be kept in a closed cupboard, so it will not be possible for the&#xD;
      investigators involved in perioperative assessment and surgery to accidentally learn if it&#xD;
      has been used or not. If the patient will be assigned to &quot;BRONCH&quot; group, scope will be&#xD;
      brought from the cupboard.&#xD;
&#xD;
      Bronchoscopy will be done with a thin, flexible bronchoscope by investigator specifically&#xD;
      designated for the task, who will not participate in postoperative assessment of the&#xD;
      patients. He/she will not be allowed to inform other investigators if bronchoscopy would be&#xD;
      performed or not.&#xD;
&#xD;
      Bronchoscopy and suctioning of secretions will be performed in a systematic manner as&#xD;
      follows: 1) main bronchi, 2) lung on non-operated side: lower lobe - middle lobe/lingula-&#xD;
      upper lobe/culmen, 3) lung on operated side starting from lower lobe bronchi towards upper&#xD;
      lobe bronchi, 4) main bronchi. Secretions will be removed from main, lobar and segmental&#xD;
      bronchi. Care will be taken not to injure bronchial mucosa. Bronchial secretions will be sent&#xD;
      for microbiological examination.&#xD;
&#xD;
      After bronchoscopy scope will be immediately transferred for cleaning and another one will be&#xD;
      placed in the cupboard.&#xD;
&#xD;
      After operation patient will be transferred to surgery ward or intensive care unit if&#xD;
      necessary.&#xD;
&#xD;
      Pain management will include local analgesia (epidural in thoracotomy, intercostal block with&#xD;
      bupivacaine performed at the end of surgery in VATS), acetaminophen, NSAIDS and opioids. Pain&#xD;
      severity will be assessed daily.&#xD;
&#xD;
      Physical examination, including auscultation, temperature measurement, heart rate,&#xD;
      respiratory rate and others will be performed twice a day. Chest x-ray will be performed in&#xD;
      the evening on the day of surgery, on postoperative day 1 and postoperative day 2 and&#xD;
      additionally if symptoms corresponding to retention of secretions, atelectasis or pneumonia&#xD;
      will be found on physical examination. C-reactive protein serum level will be measured before&#xD;
      surgery and 72 hours after surgery.&#xD;
&#xD;
      The following factors/parameters will be additionally measured and compared in both groups:&#xD;
      duration of surgery, duration of single-lung ventilation, chest tube duration, hospital stay,&#xD;
      ICU admission and its duration, results of bacteriological examination of bronchial&#xD;
      secretions, histology, TNM, stage.&#xD;
&#xD;
      Other complications will be recorded (bleeding, transfusion, prolonged air leak, residual air&#xD;
      space, wound infection, redo surgery, psychosis and others).&#xD;
&#xD;
      Chest tubes will be removed if fluid drainage will be less than 200ml/day and no air leak&#xD;
      will be observed.&#xD;
&#xD;
      Endpoints.&#xD;
&#xD;
      Primary endpoint:&#xD;
&#xD;
      1. Occurrence of atelectasis on chest x-ray on day 1, 2 or 3 after surgery&#xD;
&#xD;
      Secondary endpoint:&#xD;
&#xD;
        1. Bronchial Secretion Retention Related Complications Score (BRCS) on day 1, 2 or 3 after&#xD;
           surgery&#xD;
&#xD;
        2. Occurrence of new atrial fibrillation during day 1, 2 or 3 after surgery&#xD;
&#xD;
        3. C-reactive protein level 72 hours after surgery&#xD;
&#xD;
      BRCS will reflect a spectrum of complications resulting from retention of bronchial&#xD;
      secretions. Each of the complications will be assigned a number corresponding to severity of&#xD;
      a complication (ordinal scale), as follows:&#xD;
&#xD;
        1. Normal breath sounds on auscultation, no atelectasis on CXR, no pneumonia.&#xD;
&#xD;
        2. Residual secretions on auscultation, no atelectasis on CXR, no pneumonia.&#xD;
&#xD;
        3. Atelectasis on CXR, no pneumonia.&#xD;
&#xD;
        4. Pneumonia.&#xD;
&#xD;
      Investigators plan to enroll 200 patients, 100 patients in each group.&#xD;
&#xD;
      Statistical analysis.&#xD;
&#xD;
      The analyzed data will be presented as means, standard deviations, minimum and maximum&#xD;
      values, medians, interquartile ranges (lower quartile, upper quartile) or percentage, as&#xD;
      appropriate. Normality of the distribution will be tested with the Shapiro-Wilk's test, and&#xD;
      the equality of variances will be checked with the Levene's test. For comparison of groups,&#xD;
      unpaired t test or one-way ANOVA (for data which follow normal distribution and homogeneity&#xD;
      of variances) or Welch test will be applied. In case data will not normally distributed&#xD;
      nonparametric tests will be used - Mann-Whitney U test or the Kruskal-Wallis test with the&#xD;
      Dunn's post-hoc test. Categorical data will be analyzed with the χ2 test or the&#xD;
      Fisher-Freeman-Halton test. The relationship between variables will be analyzed with the&#xD;
      Pearson's linear correlation coefficient or the Spearman's rank correlation coefficient or&#xD;
      (and) by multivariate linear regression. All the results will be considered significant at&#xD;
      p&lt;0.05. Statistical analyses will be performed with statistical packages: STATISTICA 10.0 PL&#xD;
      (StatSoft. Inc.) or StatXact 9.0 (CytelStudio) software.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 8, 2021</start_date>
  <completion_date type="Anticipated">November 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">October 1, 2023</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>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Atelectasis.</measure>
    <time_frame>Up to 3 days after surgery.</time_frame>
    <description>Occurrence of atelectasis on chest X-ray.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Bronchial Secretion Retention Related Complications Score (BRCS).</measure>
    <time_frame>Up to 3 days after surgery.</time_frame>
    <description>BRCS will reflect a spectrum of complications resulting from retention of bronchial secretions. Each of the complication will be assigned a number in ordinal scale corresponding to severity of a complication, as follows:&#xD;
Normal breath sounds on auscultation, no atelectasis on CXR, no pneumonia.&#xD;
Residual secretions on auscultation, no atelectasis on CXR, no pneumonia.&#xD;
Atelectasis on CXR, no pneumonia.&#xD;
Pneumonia.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Atrial fibrillation.</measure>
    <time_frame>Up to 3 days after surgery.</time_frame>
    <description>Occurrence of new atrial fibrillation on physical examination confirmed by electrocardiography.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CRP.</measure>
    <time_frame>72 hours after the end of surgery.</time_frame>
    <description>Serum C-reactive protein level</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Postoperative Complications</condition>
  <condition>Thoracic Surgery</condition>
  <arm_group>
    <arm_group_label>Bronch</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Postoperative systematic bronchial aspiration.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>In this arm bronchial aspiration with bronchoscope will not be done.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Postoperative systematic bronchial aspiration.</intervention_name>
    <description>Postoperative flexible bronchoscopy and systematic bronchial aspiration.</description>
    <arm_group_label>Bronch</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pulmonary lobectomy.&#xD;
&#xD;
          -  Patients must be informed and must sign and give written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Wedge resection, segmentectomy, pneumonectomy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>89 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Piotr Gabryel, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wielkopolskie Centrum Pulmonologii i Torakochirurgii</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Łukasz Gąsiorowski, MD</last_name>
    <phone>+48608390066</phone>
    <email>luke_gas@hotmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Cezary Piwkowski, Prof</last_name>
    <email>cezary_p@hotmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Wielkopolskie Centrum Pulmonologii i Torakochirurgii</name>
      <address>
        <city>Poznań</city>
        <state>Wielkopolska</state>
        <zip>62-007</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Łukasz Gąsiorowski, Prof</last_name>
      <phone>+48608390066</phone>
      <email>luke_gas@hotmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <reference>
    <citation>Jaworski A, Goldberg SK, Walkenstein MD, Wilson B, Lippmann ML. Utility of immediate postlobectomy fiberoptic bronchoscopy in preventing atelectasis. Chest. 1988 Jul;94(1):38-43. doi: 10.1378/chest.94.1.38.</citation>
    <PMID>3289837</PMID>
  </reference>
  <reference>
    <citation>Du Rand IA, Barber PV, Goldring J, Lewis RA, Mandal S, Munavvar M, Rintoul RC, Shah PL, Singh S, Slade MG, Woolley A; BTS Interventional Bronchoscopy Guideline Group. Summary of the British Thoracic Society guidelines for advanced diagnostic and therapeutic flexible bronchoscopy in adults. Thorax. 2011 Nov;66(11):1014-5. doi: 10.1136/thoraxjnl-2011-201052.</citation>
    <PMID>22003155</PMID>
  </reference>
  <reference>
    <citation>Stolz AJ, Schutzner J, Lischke R, Simonek J, Harustiak T, Pafko P. Predictors of atelectasis after pulmonary lobectomy. Surg Today. 2008;38(11):987-92. doi: 10.1007/s00595-008-3767-x. Epub 2008 Oct 29.</citation>
    <PMID>18958555</PMID>
  </reference>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>September 28, 2017</study_first_submitted>
  <study_first_submitted_qc>October 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 11, 2017</study_first_posted>
  <last_update_submitted>July 11, 2022</last_update_submitted>
  <last_update_submitted_qc>July 11, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 12, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Bronchoscopy</keyword>
  <keyword>Respiratory Complications</keyword>
  <keyword>Anatomical Lung Resection</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Postoperative Complications</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03307018
org study id: TH-17-BR-1
nct id: NCT03307018
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Respiratory complications are the largest group of complications following anatomical lung
      resections. Most of these complications result from a disrupted evacuation of respiratory
      secretions. At present, prevention of such complications involve: aspirating of secretions
      with a catheter during surgery through an intubation tube, active postoperative
      rehabilitation, mucolytic treatment and effective postoperative pain management. Suctioning
      of secretions by a catheter through an intubation tube does not, however, allow for removal
      of secretions from entire bronchial tree. Bronchofiberoscopy with a small-diameter flexible
      bronchoscope and thorough, systematic aspiration of secretions from respiratory tract
      immediately after surgery could presumably result in more effective bronchial cleansing and
      reduce risk of respiratory complications after surgery. Although the British Thoracic Society
      guidelines do not recommend routine bronchoscopy as a standard postoperative management after
      lung resections, they are based on a single, randomized, study analyzing a small group of
      patients. Bronchoscopy with systematic aspiration of secretions done with a thin flexible
      scope is a safe procedure, without risk of complications. It does not cause any additional
      discomfort to the patients and allows for much more accurate aspiration of the bronchial
      secretions than with a catheter inserted blindly through an intubation tube. It also gives an
      opportunity to directly evaluate segmental and subsegmental bronchial patency. This is
      particularly important in patients with COPD who tend to accumulate large amounts of mucus
      secretion in the bronchial tree.
Introduction.

      Atelectasis and pneumonia are the most common complications after anatomical lung resections.
      Their occurrence in the postoperative period may necessitate treatment with antibiotics and
      fiberoptic bronchoscopy and may lead prolongation of hospital stay, diminished quality of
      life and increased cost of treatment.

      Among known risk factors, retention of bronchial secretions is probably the most important.
      Although at the end of surgery suctioning of the secretions from large airways is always
      done, it is usually performed with suction catheter inserted blindly through an endotracheal
      tube. This procedure does not allow for complete removal of secretions from all parts of
      bronchial tree and trachea. Remaining secretions may lead to postoperative atelectasis and
      pneumonia.

      Fiberoptic bronchoscopy performed with a thin scope allows for accurate visual assessment and
      precise aspiration of secretions from all main, lobar and segmental bronchi. If performed in
      a systematic way, it allows for complete removal of bronchial secretions.

      The role of routine bronchoscopic aspiration has already been evaluated in one randomized
      study. However, study group included only 20 subjects, which is too little to perform proper
      statistical analysis and draw conclusions (1).

      Study design.

      After qualification for the study informed consent will be obtained from a patient.

      Patients will be randomly assigned to one of two arms of the study: "BRONCH" or "CONTROL".
      Simple randomization method and random number generator
      (https://www.graphpad.com/quickcalcs/index.cfm) will be used.

      Initial assessment will include demographics, smoking history, comorbidities (Charlson
      Comorbidity Index, CCI and Thoracic Revised Cardiac Risk Index, thRCRI), pulmonary function
      tests, diffusion lung capacity (DLCO), computed tomography of the chest and bronchoscopy.

      Surgery will be performed under general anesthesia with double-lumen endotracheal tube
      intubation and single lung ventilation. Patients will be placed in lateral decubitus position
      and operation table will be flexed at the level of 5th - 6th rib The decision about the type
      of surgical approach (video-assisted thoracic surgery, VATS or antero-lateral muscle-sparing
      thoracotomy) will be made according to the criteria presently used, in particular size of a
      tumor and its TNM classification assessed on the basis of preoperative studies.

      Pulmonary lobectomy will be performed in standardized fashion. Pulmonary vessels (veins and
      arteries) will be closed with vascular staplers, silk loops or vascular clips. Bronchus will
      be closed with stapler or running suture. Interlobar fissures will be divided with staplers.
      Mediastinal lymph node dissection (MLND) will be performed using either monopolar
      electrocautery or high-energy device. One chest tube will be placed in case of VATS and two
      in case of thoracotomy.

      At the end of surgery, after lobectomy and MLND, catheter will be introduced through
      intubation tube and suctioning of secretions from large airways will be done. Collapsed lung
      will be re-expanded and alveolar recruitment maneuvers will be performed.

      VATS/thoracotomy wound will be closed and patient will be placed in prone position. All
      investigators, except one designated for performing bronchoscopy will leave operating room.

      At this time, it will be checked, to which arm the patient was randomly assigned. If the
      patient was assigned to "CONTROL" arm, bronchoscopy will not be done and the patient will be
      woken. If the patient was assigned to "BRONCH" arm, bronchoscopy will be done.

      Bronchoscope will be kept in a closed cupboard, so it will not be possible for the
      investigators involved in perioperative assessment and surgery to accidentally learn if it
      has been used or not. If the patient will be assigned to "BRONCH" group, scope will be
      brought from the cupboard.

      Bronchoscopy will be done with a thin, flexible bronchoscope by investigator specifically
      designated for the task, who will not participate in postoperative assessment of the
      patients. He/she will not be allowed to inform other investigators if bronchoscopy would be
      performed or not.

      Bronchoscopy and suctioning of secretions will be performed in a systematic manner as
      follows: 1) main bronchi, 2) lung on non-operated side: lower lobe - middle lobe/lingula-
      upper lobe/culmen, 3) lung on operated side starting from lower lobe bronchi towards upper
      lobe bronchi, 4) main bronchi. Secretions will be removed from main, lobar and segmental
      bronchi. Care will be taken not to injure bronchial mucosa. Bronchial secretions will be sent
      for microbiological examination.

      After bronchoscopy scope will be immediately transferred for cleaning and another one will be
      placed in the cupboard.

      After operation patient will be transferred to surgery ward or intensive care unit if
      necessary.

      Pain management will include local analgesia (epidural in thoracotomy, intercostal block with
      bupivacaine performed at the end of surgery in VATS), acetaminophen, NSAIDS and opioids. Pain
      severity will be assessed daily.

      Physical examination, including auscultation, temperature measurement, heart rate,
      respiratory rate and others will be performed twice a day. Chest x-ray will be performed in
      the evening on the day of surgery, on postoperative day 1 and postoperative day 2 and
      additionally if symptoms corresponding to retention of secretions, atelectasis or pneumonia
      will be found on physical examination. C-reactive protein serum level will be measured before
      surgery and 72 hours after surgery.

      The following factors/parameters will be additionally measured and compared in both groups:
      duration of surgery, duration of single-lung ventilation, chest tube duration, hospital stay,
      ICU admission and its duration, results of bacteriological examination of bronchial
      secretions, histology, TNM, stage.

      Other complications will be recorded (bleeding, transfusion, prolonged air leak, residual air
      space, wound infection, redo surgery, psychosis and others).

      Chest tubes will be removed if fluid drainage will be less than 200ml/day and no air leak
      will be observed.

      Endpoints.

      Primary endpoint:

      1. Occurrence of atelectasis on chest x-ray on day 1, 2 or 3 after surgery

      Secondary endpoint:

        1. Bronchial Secretion Retention Related Complications Score (BRCS) on day 1, 2 or 3 after
           surgery

        2. Occurrence of new atrial fibrillation during day 1, 2 or 3 after surgery

        3. C-reactive protein level 72 hours after surgery

      BRCS will reflect a spectrum of complications resulting from retention of bronchial
      secretions. Each of the complications will be assigned a number corresponding to severity of
      a complication (ordinal scale), as follows:

        1. Normal breath sounds on auscultation, no atelectasis on CXR, no pneumonia.

        2. Residual secretions on auscultation, no atelectasis on CXR, no pneumonia.

        3. Atelectasis on CXR, no pneumonia.

        4. Pneumonia.

      Investigators plan to enroll 200 patients, 100 patients in each group.

      Statistical analysis.

      The analyzed data will be presented as means, standard deviations, minimum and maximum
      values, medians, interquartile ranges (lower quartile, upper quartile) or percentage, as
      appropriate. Normality of the distribution will be tested with the Shapiro-Wilk's test, and
      the equality of variances will be checked with the Levene's test. For comparison of groups,
      unpaired t test or one-way ANOVA (for data which follow normal distribution and homogeneity
      of variances) or Welch test will be applied. In case data will not normally distributed
      nonparametric tests will be used - Mann-Whitney U test or the Kruskal-Wallis test with the
      Dunn's post-hoc test. Categorical data will be analyzed with the χ2 test or the
      Fisher-Freeman-Halton test. The relationship between variables will be analyzed with the
      Pearson's linear correlation coefficient or the Spearman's rank correlation coefficient or
      (and) by multivariate linear regression. All the results will be considered significant at
      p<0.05. Statistical analyses will be performed with statistical packages: STATISTICA 10.0 PL
      (StatSoft. Inc.) or StatXact 9.0 (CytelStudio) software.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Atelectasis.
time frame: Up to 3 days after surgery.
description: Occurrence of atelectasis on chest X-ray.
measure: Bronchial Secretion Retention Related Complications Score (BRCS).
time frame: Up to 3 days after surgery.
description: BRCS will reflect a spectrum of complications resulting from retention of bronchial secretions. Each of the complication will be assigned a number in ordinal scale corresponding to severity of a complication, as follows:
Normal breath sounds on auscultation, no atelectasis on CXR, no pneumonia.
Residual secretions on auscultation, no atelectasis on CXR, no pneumonia.
Atelectasis on CXR, no pneumonia.
Pneumonia.
measure: Atrial fibrillation.
time frame: Up to 3 days after surgery.
description: Occurrence of new atrial fibrillation on physical examination confirmed by electrocardiography.
measure: CRP.
time frame: 72 hours after the end of surgery.
description: Serum C-reactive protein level
arm group label: Bronch
arm group type: Experimental
description: Postoperative systematic bronchial aspiration.
arm group label: Control
arm group type: No Intervention
description: In this arm bronchial aspiration with bronchoscope will not be done.
intervention type: Procedure
intervention name: Postoperative systematic bronchial aspiration.
description: Postoperative flexible bronchoscopy and systematic bronchial aspiration.
arm group label: Bronch
criteria: 
gender: All
minimum age: 18 Years
maximum age: 89 Years
healthy volunteers: No
last name: Piotr Gabryel, MD
role: Principal Investigator
affiliation: Wielkopolskie Centrum Pulmonologii i Torakochirurgii
last name: Łukasz Gąsiorowski, MD
phone: +48608390066
email: luke_gas@hotmail.com
last name: Cezary Piwkowski, Prof
email: cezary_p@hotmail.com
facility: 
status: Recruiting
contact: 
country: Poland
citation: Jaworski A, Goldberg SK, Walkenstein MD, Wilson B, Lippmann ML. Utility of immediate postlobectomy fiberoptic bronchoscopy in preventing atelectasis. Chest. 1988 Jul;94(1):38-43. doi: 10.1378/chest.94.1.38.
PMID: 3289837
citation: Du Rand IA, Barber PV, Goldring J, Lewis RA, Mandal S, Munavvar M, Rintoul RC, Shah PL, Singh S, Slade MG, Woolley A; BTS Interventional Bronchoscopy Guideline Group. Summary of the British Thoracic Society guidelines for advanced diagnostic and therapeutic flexible bronchoscopy in adults. Thorax. 2011 Nov;66(11):1014-5. doi: 10.1136/thoraxjnl-2011-201052.
PMID: 22003155
citation: Stolz AJ, Schutzner J, Lischke R, Simonek J, Harustiak T, Pafko P. Predictors of atelectasis after pulmonary lobectomy. Surg Today. 2008;38(11):987-92. doi: 10.1007/s00595-008-3767-x. Epub 2008 Oct 29.
PMID: 18958555
responsible party type: Sponsor
mesh term: Postoperative Complications
sharing ipd: No