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

June 6, 2019 updated by: Hospital Son Espases

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

108

Phase

  • Not Applicable

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

3 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Common nasal cannula
Oxygen administration up to 4 liters according defined protocol
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.
Experimental: High flow nasal cannula
Oxygen administered with high flow nasal cannula according child weight and protocol designed for this study
Device: Oxygen administration with high flow nasal cannula, device Airvo2 Fisher and Pykel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oxygen desaturation
Time Frame: Trough study completion, an average of 2 years
Number of patients with Oxygen saturation under 94% during bronchoscopy
Trough study completion, an average of 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Moderate oxygen desaturations
Time Frame: Trough study completion, an average of 2 years
Number of patients with Oxygen saturation < 94% and > 90 %
Trough study completion, an average of 2 years
Severe oxygen desaturations
Time Frame: Trough study completion, an average of 2 years
Number of patients with Oxygen saturation< 90%
Trough study completion, an average of 2 years
Tachypnea
Time Frame: Trough study completion, an average of 2 years
Number of patients with Breath rate more than p95 fore age for more than 30 seconds
Trough study completion, an average of 2 years
Apnea
Time Frame: Trough study completion, an average of 2 years
Number of patients with Breath rate 0 for more than 20 seconds or recure intervention
Trough study completion, an average of 2 years
Bradycardia
Time Frame: Trough study completion, an average of 2 years
Number of patients with Heart rate less than p5 forte age for more than 20 seconds
Trough study completion, an average of 2 years

Collaborators and Investigators

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

Sponsor

Hospital Son Espases

Investigators

  • Principal Investigator: Artur sharluyan, MD, Ib-salut
  • Study Director: Sebastian Sailer, MD, Ib-salud
  • Study Chair: Francisco de Borja Osona Rodriguez, PhD, Ib-salud

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 (Actual)

November 10, 2015

Primary Completion (Actual)

February 28, 2019

Study Completion (Actual)

February 28, 2019

Study Registration Dates

First Submitted

May 30, 2019

First Submitted That Met QC Criteria

June 4, 2019

First Posted (Actual)

June 5, 2019

Study Record Updates

Last Update Posted (Actual)

June 10, 2019

Last Update Submitted That Met QC Criteria

June 6, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IB 3150/16 PI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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