<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/NCT02253706</url>
  </required_header>
  <id_info>
    <org_study_id>HFO-Rx1</org_study_id>
    <nct_id>NCT02253706</nct_id>
  </id_info>
  <brief_title>Oxygen Supplementation During Bronchoscopy: High Flow Versus Low Flow Oxygen</brief_title>
  <official_title>Oxygen Supplementation During Bronchoscopy: High-Flow Nasal Cannula or Low-Flow Nasal Cannula</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shaare Zedek Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shaare Zedek Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In general bronchoscopy is a safe procedure with low rate of complications. Indeed,&#xD;
      contraindications to flexible bronchoscopy are mostly relative rather than absolute. This is&#xD;
      the case of preexisting decreased blood oxygen levels which may be present in patients&#xD;
      requiring further bronchopulmonary investigation. To avoid the deleterious effects of oxygen&#xD;
      drops oxygen supplementation is recommended.&#xD;
&#xD;
      The purpose of this study is to evaluate the efficiency and safety of oxygen supplementation&#xD;
      obtained with the use of a high flow nasal cannula compared with a low flow nasal cannula&#xD;
      during flexible bronchoscopy.&#xD;
&#xD;
      Consecutive patients referred by their treating physician for bronchoscopy will be offered to&#xD;
      take part in the study. Those who wish to participate and give their consent will be randomly&#xD;
      assigned into one of two treatment groups (supplemental oxygen given via low flow nasal&#xD;
      cannula or via high flow nasal cannula).&#xD;
&#xD;
      Assignment to either treatment arm will not affect in any way the intended purpose of the&#xD;
      bronchoscopy. All patients will be closely monitored during the procedure and 2 hours&#xD;
      following its completion. Monitoring will be conducted, using strictly non-invasive measures.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>October 2014</start_date>
  <completion_date type="Anticipated">September 2016</completion_date>
  <primary_completion_date type="Anticipated">September 2016</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Oxygen desaturation index 4% (ODI4%)</measure>
    <time_frame>duration of bronchoscopy with an expected average duration of 30 minutes</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>oxygen cumulative time below 88%(OCT88%)</measure>
    <time_frame>beginning to end of bronchoscopy procedure with an expected average duration of 30minutes</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>number of bradycardic and tachycardic events</measure>
    <time_frame>beginning to end of bronchoscopy with an expected averag duration of 30 minutes</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in expired end tidal carbon dioxide before and after completion of bronchoscopy</measure>
    <time_frame>beginning to end of bronchoscopy with an expected average duration of 30 minutes</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>oxygen desaturation index 4%</measure>
    <time_frame>preprocedural to 2 hours post procedure with an expected total duration of 3 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>cumulative oxygen time 88%</measure>
    <time_frame>pre-procedural to 2 hours post precedure with an expected total duration of 3 hours</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>patient comfort during the procedure</measure>
    <time_frame>duration of bronchoscopy procedure with an expected average duration of 30 minutes</time_frame>
    <description>a numeric rating scale ranging from 1(excellent to 4(poor ) will be filled out by the patient after completion of the bronchoscopy</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Hypoxia</condition>
  <arm_group>
    <arm_group_label>Low flow nasal oxygen supplementation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Low flow nasal oxygen supplementation as per routine standard of care(control arm)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High flow nasal oxygen supplementation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>High-flow nasal ventilation: This will be carried out using the Precision Flow device (Opti-Flow, Auckland, New Zealand). This device is intended to add warm moisture to breathing gases from an external source. Flow rate via the nasal cannula will be kept at 50 Liters/min and fractional inspired oxygen concentration will be set at 0.35</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>High flow nasal oxygen supplementation</intervention_name>
    <description>High-flow nasal ventilation: This will be carried out using the Precision Flow device (Opti-Flow, Auckland, New Zealand). This device is intended to add warm moisture to breathing gases from an external source. Flow rate via the nasal cannula will be kept at 50 Liters/min and fractional inspired oxygen concentration will be set at 0.35.</description>
    <arm_group_label>High flow nasal oxygen supplementation</arm_group_label>
    <other_name>Precision Flow device (Opti-Flow, Auckland, New Zealand)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>low flow nasal oxygen supplementation</intervention_name>
    <description>Low-flow nasal ventilation: This will be carried out using a regular nasal cannula fed with oxygen at flow rates from 2 to 6 liters/minute.</description>
    <arm_group_label>Low flow nasal oxygen supplementation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients scheduled to undergo routine bronchoscopy for diagnostic purposes&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  inability to give an informed consent&#xD;
&#xD;
          -  nasal deformities&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ayal Romem, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shaare Zedek Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ayal Romem, MD</last_name>
    <phone>97226555676</phone>
    <email>pulmoromem@szmc.org.il</email>
  </overall_contact>
  <location>
    <facility>
      <name>Shaare Zedek Medical Center</name>
      <address>
        <city>Jerusalem</city>
        <zip>3235</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <reference>
    <citation>Albertini R, Harrel JH, Moser KM. Letter: Hypoxemia during fiberoptic bronchoscopy. Chest. 1974 Jan;65(1):117-8. doi: 10.1378/chest.65.1.117. No abstract available.</citation>
    <PMID>4809326</PMID>
  </reference>
  <reference>
    <citation>Matsushima Y, Jones RL, King EG, Moysa G, Alton JD. Alterations in pulmonary mechanics and gas exchange during routine fiberoptic bronchoscopy. Chest. 1984 Aug;86(2):184-8. doi: 10.1378/chest.86.2.184.</citation>
    <PMID>6744959</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. British Thoracic Society guideline for diagnostic flexible bronchoscopy in adults: accredited by NICE. Thorax. 2013 Aug;68 Suppl 1:i1-i44. doi: 10.1136/thoraxjnl-2013-203618. No abstract available.</citation>
    <PMID>23860341</PMID>
  </reference>
  <reference>
    <citation>Roca O, Masclans JR, Laborda C, Sacanell J, Serra J. High-flow nasal cannula improves oxygenation in hypoxemic respiratory failure. Intensive Care Med 2007; 33:S86</citation>
  </reference>
  <reference>
    <citation>Williams AB, Ritchie JE, Gerard C. Evaluation of a high-flow nasal oxygen delivery system: gas analysis and pharyngeal pressures. Intensive Care Med 2006; 32: S219</citation>
  </reference>
  <reference>
    <citation>Lomas C, Roca O, Alvarez A, Masclans JR. Fibroscopy in patients with hypoxemic respiratory insufficiency: Utility of the high-flow nasal cannula. Respr Med (CME) 2009; 2: 121-124</citation>
  </reference>
  <reference>
    <citation>Lucangelo U, Vassallo FG, Marras E, Ferluga M, Beziza E, Comuzzi L, Berlot G, Zin WA. High-flow nasal interface improves oxygenation in patients undergoing bronchoscopy. Crit Care Res Pract. 2012;2012:506382. doi: 10.1155/2012/506382. Epub 2012 May 20.</citation>
    <PMID>22666567</PMID>
  </reference>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>September 2, 2014</study_first_submitted>
  <study_first_submitted_qc>September 28, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 1, 2014</study_first_posted>
  <last_update_submitted>September 28, 2014</last_update_submitted>
  <last_update_submitted_qc>September 28, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 1, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>bronchoscopy</keyword>
  <keyword>hypoxia</keyword>
  <keyword>oxygen supplementation</keyword>
  <keyword>safety</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypoxia</mesh_term>
  </condition_browse>
  <!-- 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/NCT02253706
org study id: HFO-Rx1
nct id: NCT02253706
lead sponsor: 
has dmc: No
In general bronchoscopy is a safe procedure with low rate of complications. Indeed,
      contraindications to flexible bronchoscopy are mostly relative rather than absolute. This is
      the case of preexisting decreased blood oxygen levels which may be present in patients
      requiring further bronchopulmonary investigation. To avoid the deleterious effects of oxygen
      drops oxygen supplementation is recommended.

      The purpose of this study is to evaluate the efficiency and safety of oxygen supplementation
      obtained with the use of a high flow nasal cannula compared with a low flow nasal cannula
      during flexible bronchoscopy.

      Consecutive patients referred by their treating physician for bronchoscopy will be offered to
      take part in the study. Those who wish to participate and give their consent will be randomly
      assigned into one of two treatment groups (supplemental oxygen given via low flow nasal
      cannula or via high flow nasal cannula).

      Assignment to either treatment arm will not affect in any way the intended purpose of the
      bronchoscopy. All patients will be closely monitored during the procedure and 2 hours
      following its completion. Monitoring will be conducted, using strictly non-invasive measures.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Oxygen desaturation index 4% (ODI4%)
time frame: duration of bronchoscopy with an expected average duration of 30 minutes
measure: oxygen cumulative time below 88%(OCT88%)
time frame: beginning to end of bronchoscopy procedure with an expected average duration of 30minutes
measure: number of bradycardic and tachycardic events
time frame: beginning to end of bronchoscopy with an expected averag duration of 30 minutes
measure: change in expired end tidal carbon dioxide before and after completion of bronchoscopy
time frame: beginning to end of bronchoscopy with an expected average duration of 30 minutes
measure: oxygen desaturation index 4%
time frame: preprocedural to 2 hours post procedure with an expected total duration of 3 hours
measure: cumulative oxygen time 88%
time frame: pre-procedural to 2 hours post precedure with an expected total duration of 3 hours
measure: patient comfort during the procedure
time frame: duration of bronchoscopy procedure with an expected average duration of 30 minutes
description: a numeric rating scale ranging from 1(excellent to 4(poor ) will be filled out by the patient after completion of the bronchoscopy
arm group label: Low flow nasal oxygen supplementation
arm group type: Active Comparator
description: Low flow nasal oxygen supplementation as per routine standard of care(control arm)
arm group label: High flow nasal oxygen supplementation
arm group type: Experimental
description: High-flow nasal ventilation: This will be carried out using the Precision Flow device (Opti-Flow, Auckland, New Zealand). This device is intended to add warm moisture to breathing gases from an external source. Flow rate via the nasal cannula will be kept at 50 Liters/min and fractional inspired oxygen concentration will be set at 0.35
intervention type: Device
intervention name: High flow nasal oxygen supplementation
description: High-flow nasal ventilation: This will be carried out using the Precision Flow device (Opti-Flow, Auckland, New Zealand). This device is intended to add warm moisture to breathing gases from an external source. Flow rate via the nasal cannula will be kept at 50 Liters/min and fractional inspired oxygen concentration will be set at 0.35.
arm group label: High flow nasal oxygen supplementation
other name: Precision Flow device (Opti-Flow, Auckland, New Zealand)
intervention type: Device
intervention name: low flow nasal oxygen supplementation
description: Low-flow nasal ventilation: This will be carried out using a regular nasal cannula fed with oxygen at flow rates from 2 to 6 liters/minute.
arm group label: Low flow nasal oxygen supplementation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ayal Romem, MD
role: Principal Investigator
affiliation: Shaare Zedek Medical Center
last name: Ayal Romem, MD
phone: 97226555676
email: pulmoromem@szmc.org.il
facility: 
country: Israel
citation: Albertini R, Harrel JH, Moser KM. Letter: Hypoxemia during fiberoptic bronchoscopy. Chest. 1974 Jan;65(1):117-8. doi: 10.1378/chest.65.1.117. No abstract available.
PMID: 4809326
citation: Matsushima Y, Jones RL, King EG, Moysa G, Alton JD. Alterations in pulmonary mechanics and gas exchange during routine fiberoptic bronchoscopy. Chest. 1984 Aug;86(2):184-8. doi: 10.1378/chest.86.2.184.
PMID: 6744959
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. British Thoracic Society guideline for diagnostic flexible bronchoscopy in adults: accredited by NICE. Thorax. 2013 Aug;68 Suppl 1:i1-i44. doi: 10.1136/thoraxjnl-2013-203618. No abstract available.
PMID: 23860341
citation: Roca O, Masclans JR, Laborda C, Sacanell J, Serra J. High-flow nasal cannula improves oxygenation in hypoxemic respiratory failure. Intensive Care Med 2007; 33:S86
citation: Williams AB, Ritchie JE, Gerard C. Evaluation of a high-flow nasal oxygen delivery system: gas analysis and pharyngeal pressures. Intensive Care Med 2006; 32: S219
citation: Lomas C, Roca O, Alvarez A, Masclans JR. Fibroscopy in patients with hypoxemic respiratory insufficiency: Utility of the high-flow nasal cannula. Respr Med (CME) 2009; 2: 121-124
citation: Lucangelo U, Vassallo FG, Marras E, Ferluga M, Beziza E, Comuzzi L, Berlot G, Zin WA. High-flow nasal interface improves oxygenation in patients undergoing bronchoscopy. Crit Care Res Pract. 2012;2012:506382. doi: 10.1155/2012/506382. Epub 2012 May 20.
PMID: 22666567
responsible party type: Sponsor
mesh term: Hypoxia