Assessment of the Efficacy of Tracheal Oxygen Administration During Bronchoscopy - a Phase II Trial

Hypoxaemia Clinical Trial

Official title:

Assessment of the Efficacy of Tracheal Oxygen Administration During Bronchoscopy - a Phase II Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01786642
• Other study ID #: AETOB
• Status: Recruiting
• Phase: N/A
• First received: February 1, 2013
• Last updated: February 6, 2013
• Start date: February 2013
• Est. completion date: April 2014

Study information

• Verified date: February 2013
• Source: Katholieke Universiteit Leuven
• Contact: Jonas Yserbyt, MD
• Phone: +3216346801
• Email: jonas.yserbyt[@]uzleuven.be
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
• Study type: Observational

Clinical Trial Summary

The aim of the present study is to measure the time to correction of O2 saturation when in case of desaturation below 90%, O2 administration is switched from the nasal to the tracheal route at a similar flow rate.

Description:

The development of a flexible bronchoscope with a channel dedicated to O2 administration might allow optimization of the oxygen supplementation during bronchoscopy, which reduces the risk of per- and peri-procedural hypoxemia. The investigators will conduct a pilot study corroborating the hypothesis that tracheal supplementation of oxygen during flexible bronchoscopy is advantageous in comparison to nasal cannula supplementation.

The concept of our trial consists of a mono-centric observational study performed in the endoscopy suite of the Respiratory Division, University Hospitals Leuven. All patients will be given informed consent before inclusion.

The aim of the present study is to measure the time to correction of O2 saturation when in case of desaturation below 90%, O2 administration is switched from the nasal to the tracheal route at a similar flow rate.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: April 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• patients referred for flexible bronchoscopy

Exclusion Criteria:

• broncho-alveolar lavage

• endobronchial plugging

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hypoxaemia

Locations

Country	Name	City	State
Belgium	University hospitals leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Katholieke Universiteit Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to correction of SpO2		procedure	No