Safety Study of Non-invasive Ventilation Versus High-flow Oxygen in Patients With Hypoxemic Respiratory Failure Undergoing Fiberoptic Bronchoscopy.

Not Applicable

Completed

• Conditions: Respiratory Failure
• Interventions: Device: high-flow oxygen; Device: non-invasive ventilation; Procedure: fiberoptic bronchoscopy

• Registration Number: NCT01870765
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

Brief Summary

Bronchoscopy with broncho-alveolar lavage is a diagnostic tool in patients with pneumonia. Especially patients with acute or chronic pulmonary diseases are at risk of respiratory failure during or after bronchoscopy. It is known that in these cases bronchoscopy can be performed safely using non-invasive ventilation. It seems probable that high-flow oxygen, which is used in the treatment of patients with hypoxemic respiratory failure, is equally effective in preventing the development of respiratory failure during fiberoptic bronchoscopy while improving patient comfort. In this prospective randomised study the safety of high-flow oxygen is compared with non-invasive ventilation in patients with hypoxemic respiratory failure undergoing fiberoptic bronchoscopy.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-05-30
• Study First Submitted QC: 2013-06-03
• Study First Posted: 2013-06-06
• Study Start: 2013-07
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-10
• Last Update Posted: 2020-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• patients treated in an intensive care unit
• indication for bronchoscopy and broncho-alveolar lavage
• presence of hypoxemic (SaO2/fraction of inspired oxygen(FiO2): 300 or less) and/or hypercapnic respiratory failure

Exclusion Criteria

• patients already on invasive ventilation
• indication for intubation
• blocked nasopharynx
• contraindications for non-invasive ventilation or high-flow oxygen

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
high-flow oxygen	high-flow oxygen	Performance of bronchoscopy during high-flow oxygen therapy.
non-invasive ventilation	fiberoptic bronchoscopy	Performance of bronchoscopy during non-invasive ventilation.
non-invasive ventilation	non-invasive ventilation	Performance of bronchoscopy during non-invasive ventilation.
high-flow oxygen	fiberoptic bronchoscopy	Performance of bronchoscopy during high-flow oxygen therapy.

Primary Outcome Measures

Name	Time	Method
Mean decrease in the saturation of oxygen (SpO2) during bronchoscopy.	during fiberoptic bronchoscopy

Secondary Outcome Measures

Name	Time	Method
Changes in blood gases after the completion of fiberoptic bronchoscopy.	1 hour after the completion of bronchoscopy

Trial Locations

Locations (1)

Universitätsklinikum Hamburg-Eppendorf, Department of Intensive Care Medicine; 🇩🇪 Hamburg, Germany