Oxygen Supplementation During Bronchoscopy: High Flow Versus Low Flow Oxygen

Shaare Zedek Medical Center

Status: Unknown

Conditions: Hypoxia

Treatments: Device: High flow nasal oxygen supplementation; Device: low flow nasal oxygen supplementation

Study type: Interventional

Funder types: Other

Identifiers

NCT02253706

HFO-Rx1

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients scheduled to undergo routine bronchoscopy for diagnostic purposes

Exclusion criteria

• inability to give an informed consent
• nasal deformities

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Low flow nasal oxygen supplementation

Active Comparator group

Description:

Low flow nasal oxygen supplementation as per routine standard of care(control arm)

Treatment:

Device: low flow nasal oxygen supplementation

High flow nasal oxygen supplementation

Experimental group

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

Treatment:

Device: High flow nasal oxygen supplementation