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NCT01870765 Clinical Trial

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

Respiratory Failure Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01870765
Other study ID # PV-4442
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 2013
Est. completion date February 2014

Study information
Verified date November 2020
Source Universitätsklinikum Hamburg-Eppendorf
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date February 2014
Est. primary completion date February 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• non-invasive ventilation
non-invasive ventilation via face mask
• high-flow oxygen
high-flow oxygen via nasal cannula
Procedure:
• fiberoptic bronchoscopy
fiberoptic bronchoscopy including broncho-alveolar lavage

Locations
Country Name City State
Germany Universitätsklinikum Hamburg-Eppendorf, Department of Intensive Care Medicine Hamburg

Sponsors (1)
Lead Sponsor Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Simon M, Braune S, Frings D, Wiontzek AK, Klose H, Kluge S. High-flow nasal cannula oxygen versus non-invasive ventilation in patients with acute hypoxaemic respiratory failure undergoing flexible bronchoscopy--a prospective randomised trial. Crit Care. 2 — View Citation

Outcome
Type Measure Description Time frame Safety issue
Other Requirement of intubation after the completion of bronchoscopy. 8 hours after the completion of bronchoscopy
Primary Mean decrease in the saturation of oxygen (SpO2) during bronchoscopy. during fiberoptic bronchoscopy
Secondary Changes in blood gases after the completion of fiberoptic bronchoscopy. 1 hour after the completion of bronchoscopy
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