Oxygen Administration During Bronchoscopy in Children, High Flow and Common Nasal Cannula: a Randomized Controled Trial

Comparison of Oxygen Adminstration by Nasal Cannula and High Flow Cannula During Bronchoscopy

Sponsors

Lead sponsor: Hospital Son Espases

Source Hospital Son Espases
Brief Summary

Randomized controled trial to compare oxygen desaturation during fiberoptic bronchoscopy using oxygen administered with nasal prongs and high flow nasal cannula. Drops in oxygen saturation are frequent during bronchoscopy and limit the procedure compromising patient security. The investigator's aim is to contribute to select better way of oxygen administration which could prevent desaturations during bronchoscopy in children.

Overall Status Completed
Start Date November 10, 2015
Completion Date February 28, 2019
Primary Completion Date February 28, 2019
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Oxygen desaturation Trough study completion, an average of 2 years
Secondary Outcome
Measure Time Frame
Moderate oxygen desaturations Trough study completion, an average of 2 years
Severe oxygen desaturations Trough study completion, an average of 2 years
Tachypnea Trough study completion, an average of 2 years
Apnea Trough study completion, an average of 2 years
Bradycardia Trough study completion, an average of 2 years
Enrollment 108
Condition
Intervention

Intervention type: Device

Intervention name: Oxygen administration with Common nasal cannula

Description: Oxygen administration during elective flexible bronchoscopy in children with high flow nasal cannula with inspired oxygen fraction 1.

Arm group label: Common nasal cannula

Intervention type: Device

Intervention name: Oxygen administration with high flow nasal cannula, device Airvo2 Fisher and Pykel

Arm group label: High flow nasal cannula

Eligibility

Criteria:

Inclusion Criteria:

- elective flexible bronchoscopy

Exclusion Criteria:

- admitted in Neonatal intensive care

- previous respiratory support: oxygen any device, non invasive or invasive ventilation

- patient who may benefit with continuous positive pressure during procedure

Gender: All

Minimum age: N/A

Maximum age: 16 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Verification Date

June 2019

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Common nasal cannula

Arm group type: Active Comparator

Description: Oxygen administration up to 4 liters according defined protocol

Arm group label: High flow nasal cannula

Arm group type: Experimental

Description: Oxygen administered with high flow nasal cannula according child weight and protocol designed for this study

Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Prevention

Masking: None (Open Label)

Source: ClinicalTrials.gov