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CompletedNCT01870765Updated Nov 13, 2020

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

An interventional study of non-invasive ventilation and high-flow oxygen in Respiratory Failure, sponsored by Universitätsklinikum Hamburg-Eppendorf. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-11-13.

Sponsored by Universitätsklinikum Hamburg-Eppendorf · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Respiratory Failure
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In context

Respiratory Insufficiency

1,650 studies on the registry are indexed under Respiratory Insufficiency; 296 are open to participants now.

This study's enrollment of 40 is below the median of 55 across 1,043 interventional studies indexed under Respiratory Insufficiency.

Browse Respiratory Insufficiency studies →

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf is the lead sponsor of 403 studies on the registry; 83 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Active comparator
    non-invasive ventilation

    Performance of bronchoscopy during non-invasive ventilation.

    Device: non-invasive ventilation · Procedure: fiberoptic bronchoscopy

  • Experimental
    high-flow oxygen

    Performance of bronchoscopy during high-flow oxygen therapy.

    Device: high-flow oxygen · Procedure: fiberoptic bronchoscopy

Interventions

  • Devicenon-invasive ventilation

    non-invasive ventilation via face mask

  • Devicehigh-flow oxygen

    high-flow oxygen via nasal cannula

  • Procedurefiberoptic bronchoscopy

    fiberoptic bronchoscopy including broncho-alveolar lavage

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What researchers measure

Primary outcomes

  1. Mean decrease in the saturation of oxygen (SpO2) during bronchoscopy.

    Time frame: during fiberoptic bronchoscopy

Secondary outcomes

  1. Changes in blood gases after the completion of fiberoptic bronchoscopy.

    Time frame: 1 hour after the completion of bronchoscopy

Other outcomes

  1. Requirement of intubation after the completion of bronchoscopy.

    Time frame: 8 hours after the completion of bronchoscopy

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Study locations

1 site
  • Universitätsklinikum Hamburg-Eppendorf, Department of Intensive Care Medicine
    Hamburg, 20246, Germany
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References and documents

Publications

  • 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. PubMed 25529351 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 13, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01870765
Lead sponsor
Universitätsklinikum Hamburg-Eppendorf
Responsible party
Stefan Kluge (PD Dr. Stefan Kluge, Universitätsklinikum Hamburg-Eppendorf) — Principal investigator
First posted
Jun 6, 2013
Start date
Jul 2013
Primary completion
Feb 2014
Completion
Feb 2014
Last update
Nov 13, 2020
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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