Oxygen Supplementation During Bronchoscopy: High Flow Versus Low Flow Oxygen

September 28, 2014 updated by: Shaare Zedek Medical Center

Oxygen Supplementation During Bronchoscopy: High-Flow Nasal Cannula or Low-Flow Nasal Cannula

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Jerusalem, Israel, 3235
        • Shaare Zedek Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients scheduled to undergo routine bronchoscopy for diagnostic purposes

Exclusion Criteria:

  • inability to give an informed consent
  • nasal deformities

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Low flow nasal oxygen supplementation
Low flow nasal oxygen supplementation as per routine standard of care(control arm)
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.
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
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 Names:
  • Precision Flow device (Opti-Flow, Auckland, New Zealand)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Oxygen desaturation index 4% (ODI4%)
Time Frame: duration of bronchoscopy with an expected average duration of 30 minutes
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
beginning to end of bronchoscopy procedure with an expected average duration of 30minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
number of bradycardic and tachycardic events
Time Frame: beginning to end of bronchoscopy with an expected averag duration of 30 minutes
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
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
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
pre-procedural to 2 hours post precedure with an expected total duration of 3 hours

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
duration of bronchoscopy procedure with an expected average duration of 30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shaare Zedek Medical Center

Investigators

  • Principal Investigator: Ayal Romem, MD, Shaare Zedek Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Anticipated)

September 1, 2016

Study Completion (Anticipated)

September 1, 2016

Study Registration Dates

First Submitted

September 2, 2014

First Submitted That Met QC Criteria

September 28, 2014

First Posted (Estimate)

October 1, 2014

Study Record Updates

Last Update Posted (Estimate)

October 1, 2014

Last Update Submitted That Met QC Criteria

September 28, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HFO-Rx1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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