Back to resultsSafety Study of Non-invasive Ventilation Versus High-flow Oxygen in Patients With Hypoxemic Respiratory Failure Undergoing Fiberoptic Bronchoscopy.
Primary Purpose
Respiratory Failure
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
non-invasive ventilation
high-flow oxygen
fiberoptic bronchoscopy
Sponsored by
About this trial
This is an interventional treatment trial for Respiratory Failure
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
Sites / Locations
- Universitätsklinikum Hamburg-Eppendorf, Department of Intensive Care Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
non-invasive ventilation
high-flow oxygen
Arm Description
Performance of bronchoscopy during non-invasive ventilation.
Performance of bronchoscopy during high-flow oxygen therapy.
Outcomes
Primary Outcome Measures
Mean decrease in the saturation of oxygen (SpO2) during bronchoscopy.
Secondary Outcome Measures
Changes in blood gases after the completion of fiberoptic bronchoscopy.
Full Information
NCT ID
NCT01870765
First Posted
May 30, 2013
Last Updated
November 10, 2020
Sponsor
Universitätsklinikum Hamburg-Eppendorf
1. Study Identification
Unique Protocol Identification Number
NCT01870765
Brief Title
Safety Study of Non-invasive Ventilation Versus High-flow Oxygen in Patients With Hypoxemic Respiratory Failure Undergoing Fiberoptic Bronchoscopy.
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.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitätsklinikum Hamburg-Eppendorf
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
non-invasive ventilation
Arm Type
Active Comparator
Arm Description
Performance of bronchoscopy during non-invasive ventilation.
Arm Title
high-flow oxygen
Arm Type
Experimental
Arm Description
Performance of bronchoscopy during high-flow oxygen therapy.
Intervention Type
Device
Intervention Name(s)
non-invasive ventilation
Intervention Description
non-invasive ventilation via face mask
Intervention Type
Device
Intervention Name(s)
high-flow oxygen
Intervention Description
high-flow oxygen via nasal cannula
Intervention Type
Procedure
Intervention Name(s)
fiberoptic bronchoscopy
Intervention Description
fiberoptic bronchoscopy including broncho-alveolar lavage
Primary Outcome Measure Information:
Title
Mean decrease in the saturation of oxygen (SpO2) during bronchoscopy.
Time Frame
during fiberoptic bronchoscopy
Secondary Outcome Measure Information:
Title
Changes in blood gases after the completion of fiberoptic bronchoscopy.
Time Frame
1 hour after the completion of bronchoscopy
Other Pre-specified Outcome Measures:
Title
Requirement of intubation after the completion of bronchoscopy.
Time Frame
8 hours after the completion of bronchoscopy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Universitätsklinikum Hamburg-Eppendorf, Department of Intensive Care Medicine
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
25529351
Citation
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. 2014 Dec 22;18(6):712. doi: 10.1186/s13054-014-0712-9.
Results Reference
result
Learn more about this trial
Safety Study of Non-invasive Ventilation Versus High-flow Oxygen in Patients With Hypoxemic Respiratory Failure Undergoing Fiberoptic Bronchoscopy.
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