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

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

Sponsors

Lead sponsor: Universitätsklinikum Hamburg-Eppendorf

Source 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.

Overall Status Completed
Start Date July 2013
Primary Completion Date February 2014
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Mean decrease in the saturation of oxygen (SpO2) during bronchoscopy. during fiberoptic bronchoscopy
Secondary Outcome
Measure Time Frame
Changes in blood gases after the completion of fiberoptic bronchoscopy. 1 hour after the completion of bronchoscopy
Enrollment 40
Condition
Intervention

Intervention type: Device

Intervention name: non-invasive ventilation

Description: non-invasive ventilation via face mask

Arm group label: non-invasive ventilation

Intervention type: Device

Intervention name: high-flow oxygen

Description: high-flow oxygen via nasal cannula

Arm group label: high-flow oxygen

Intervention type: Procedure

Intervention name: fiberoptic bronchoscopy

Description: fiberoptic bronchoscopy including broncho-alveolar lavage

Eligibility

Criteria:

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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Location
facility
Universitätsklinikum Hamburg-Eppendorf, Department of Intensive Care Medicine
Location Countries

Germany

Verification Date

February 2014

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Universitätsklinikum Hamburg-Eppendorf

Investigator full name: Stefan Kluge

Investigator title: PD Dr. Stefan Kluge

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: non-invasive ventilation

Arm group type: Active Comparator

Description: Performance of bronchoscopy during non-invasive ventilation.

Arm group label: high-flow oxygen

Arm group type: Experimental

Description: Performance of bronchoscopy during high-flow oxygen therapy.

Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov