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

November 10, 2020 updated by: Stefan Kluge, Universitätsklinikum Hamburg-Eppendorf

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hamburg, Germany, 20246
        • Universitätsklinikum Hamburg-Eppendorf, Department of Intensive Care Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: non-invasive ventilation
Performance of bronchoscopy during non-invasive ventilation.
Device: non-invasive ventilation
non-invasive ventilation via face mask
Procedure: fiberoptic bronchoscopy
fiberoptic bronchoscopy including broncho-alveolar lavage
Experimental: high-flow oxygen
Performance of bronchoscopy during high-flow oxygen therapy.
Procedure: fiberoptic bronchoscopy
fiberoptic bronchoscopy including broncho-alveolar lavage
Device: high-flow oxygen
high-flow oxygen via nasal cannula

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean decrease in the saturation of oxygen (SpO2) during bronchoscopy.
Time Frame: during fiberoptic bronchoscopy
during fiberoptic bronchoscopy

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in blood gases after the completion of fiberoptic bronchoscopy.
Time Frame: 1 hour after the completion of bronchoscopy
1 hour after the completion of bronchoscopy

Other Outcome Measures

Outcome Measure
Time Frame
Requirement of intubation after the completion of bronchoscopy.
Time Frame: 8 hours after the completion of bronchoscopy
8 hours after the completion of bronchoscopy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

May 30, 2013

First Submitted That Met QC Criteria

June 3, 2013

First Posted (Estimate)

June 6, 2013

Study Record Updates

Last Update Posted (Actual)

November 13, 2020

Last Update Submitted That Met QC Criteria

November 10, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PV-4442

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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