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Oxygen Supplementation During Bronchoscopy: High Flow Versus Low Flow Oxygen

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ClinicalTrials.gov Identifier: NCT02253706
Recruitment Status : Unknown
Verified July 2014 by Shaare Zedek Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : October 1, 2014
Last Update Posted : October 1, 2014
Sponsor:
Information provided by (Responsible Party):
Shaare Zedek Medical Center

Tracking Information
First Submitted Date  ICMJE September 2, 2014
First Posted Date  ICMJE October 1, 2014
Last Update Posted Date October 1, 2014
Study Start Date  ICMJE October 2014
Estimated Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 28, 2014)
  • Oxygen desaturation index 4% (ODI4%) [ Time Frame: duration of bronchoscopy with an expected average duration of 30 minutes ]
  • oxygen cumulative time below 88%(OCT88%) [ Time Frame: beginning to end of bronchoscopy procedure with an expected average duration of 30minutes ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 28, 2014)
  • number of bradycardic and tachycardic events [ Time Frame: beginning to end of bronchoscopy with an expected averag duration of 30 minutes ]
  • 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 ]
  • oxygen desaturation index 4% [ Time Frame: preprocedural to 2 hours post procedure with an expected total duration of 3 hours ]
  • cumulative oxygen time 88% [ Time Frame: pre-procedural to 2 hours post precedure with an expected total duration of 3 hours ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: September 28, 2014)
patient comfort during the procedure [ Time Frame: duration of bronchoscopy procedure with an expected average duration of 30 minutes ]
a numeric rating scale ranging from 1(excellent to 4(poor ) will be filled out by the patient after completion of the bronchoscopy
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Oxygen Supplementation During Bronchoscopy: High Flow Versus Low Flow Oxygen
Official Title  ICMJE Oxygen Supplementation During Bronchoscopy: High-Flow Nasal Cannula or Low-Flow Nasal Cannula
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Hypoxia
Intervention  ICMJE
  • Device: High flow nasal oxygen supplementation
    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.
    Other Name: Precision Flow device (Opti-Flow, Auckland, New Zealand)
  • Device: low flow nasal oxygen supplementation
    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.
Study Arms  ICMJE
  • Active Comparator: Low flow nasal oxygen supplementation
    Low flow nasal oxygen supplementation as per routine standard of care(control arm)
    Intervention: Device: low flow nasal oxygen supplementation
  • Experimental: High flow nasal oxygen supplementation
    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: Device: High flow nasal oxygen supplementation
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 28, 2014)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2016
Estimated Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • patients scheduled to undergo routine bronchoscopy for diagnostic purposes

Exclusion Criteria:

  • inability to give an informed consent
  • nasal deformities
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02253706
Other Study ID Numbers  ICMJE HFO-Rx1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Shaare Zedek Medical Center
Study Sponsor  ICMJE Shaare Zedek Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ayal Romem, MD Shaare Zedek Medical Center
PRS Account Shaare Zedek Medical Center
Verification Date July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP