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

Respiratory Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03976167
• Other study ID #: IB 3150/16 PI
• Status: Completed
• Phase: N/A
• Start date: November 10, 2015
• Est. completion date: February 28, 2019

Study information

• Verified date: June 2019
• Source: Hospital Son Espases
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: February 28, 2019
• Est. primary completion date: February 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Respiration Disorders
• Respiratory Disease
• Respiratory Tract Diseases

Intervention

Device:
• Oxygen administration with Common nasal cannula
Oxygen administration during elective flexible bronchoscopy in children with high flow nasal cannula with inspired oxygen fraction 1.
• Oxygen administration with high flow nasal cannula, device Airvo2 Fisher and Pykel

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Son Espases

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxygen desaturation	Number of patients with Oxygen saturation under 94% during bronchoscopy	Trough study completion, an average of 2 years
Secondary	Moderate oxygen desaturations	Number of patients with Oxygen saturation < 94% and > 90 %	Trough study completion, an average of 2 years
Secondary	Severe oxygen desaturations	Number of patients with Oxygen saturation< 90%	Trough study completion, an average of 2 years
Secondary	Tachypnea	Number of patients with Breath rate more than p95 fore age for more than 30 seconds	Trough study completion, an average of 2 years
Secondary	Apnea	Number of patients with Breath rate 0 for more than 20 seconds or recure intervention	Trough study completion, an average of 2 years
Secondary	Bradycardia	Number of patients with Heart rate less than p5 forte age for more than 20 seconds	Trough study completion, an average of 2 years