Oxygen Supplementation During Bronchoscopy: High Flow Versus Low Flow Oxygen

Not Applicable

• Conditions: Hypoxia
• Interventions: Device: High flow nasal oxygen supplementation; Device: low flow nasal oxygen supplementation

• Registration Number: NCT02253706
• Lead Sponsor: Shaare Zedek Medical Center

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 available

Study Timeline

• Status Verified: 2014-07
• Study First Submitted: 2014-09-02
• Study First Submitted QC: 2014-09-28
• Last Update Submitted: 2014-09-28
• Study Start: 2014-10
• Study First Posted: 2014-10-01
• Last Update Posted: 2014-10-01
• Primary Completion: 2016-09
• Study Completion: 2016-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• patients scheduled to undergo routine bronchoscopy for diagnostic purposes

Exclusion Criteria

• inability to give an informed consent
• nasal deformities

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High flow nasal oxygen supplementation	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
Low flow nasal oxygen supplementation	low flow nasal oxygen supplementation	Low flow nasal oxygen supplementation as per routine standard of care(control arm)

Primary Outcome Measures

Name	Time	Method
Oxygen desaturation index 4% (ODI4%)	duration of bronchoscopy with an expected average duration of 30 minutes
oxygen cumulative time below 88%(OCT88%)	beginning to end of bronchoscopy procedure with an expected average duration of 30minutes

Secondary Outcome Measures

Name	Time	Method
number of bradycardic and tachycardic events	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	beginning to end of bronchoscopy with an expected average duration of 30 minutes
oxygen desaturation index 4%	preprocedural to 2 hours post procedure with an expected total duration of 3 hours
cumulative oxygen time 88%	pre-procedural to 2 hours post precedure with an expected total duration of 3 hours

Trial Locations

Locations (1)

Shaare Zedek Medical Center; 🇮🇱 Jerusalem, Israel