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

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

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.

Study Overview

• Status: Unknown
• Conditions: Hypoxaemia

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • Recruiting
    • University Hospitals Leuven
    • Contact: Jonas Yserbyt, MD; Phone Number: +3216346801; Email: jonas.yserbyt@uzleuven.be
    • Principal Investigator: Jonas Yserbyt, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

all patients referred for flexible bronchoscopy

Description

Inclusion Criteria:

• patients referred for flexible bronchoscopy

Exclusion Criteria:

• broncho-alveolar lavage
• endobronchial plugging

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
conscious; bronchoscopy without sedative drugs
conscious sedation; bronchoscopy under midazolam

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time to correction of SpO2	procedure

Collaborators and Investigators

• Sponsor: KU Leuven
• Investigators: Study Director: Christophe Dooms, Md PhD, Universitaire Ziekenhuizen KU Leuven

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Anticipated): December 1, 2013
• Study Completion (Anticipated): April 1, 2014

Study Registration Dates

• First Submitted: February 1, 2013
• First Submitted That Met QC Criteria: February 6, 2013
• First Posted (Estimate): February 8, 2013

Study Record Updates

• Last Update Posted (Estimate): February 8, 2013
• Last Update Submitted That Met QC Criteria: February 6, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Hypoxia
• Other Study ID Numbers: AETOB