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Completed

NCT Number: NCT01870765

Safety Study 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.

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Key information

Conditions

Respiratory Failure Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitätsklinikum Hamburg-Eppendorf, Department of Intensive Care Medicine

Hamburg, 20246, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-invasive ventilation

Device

non-invasive ventilation via face mask

High-flow oxygen

Device

high-flow oxygen via nasal cannula

fiberoptic bronchoscopy

Procedure

fiberoptic bronchoscopy including broncho-alveolar lavage

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

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jun 6, 2013
Registry last updated
Nov 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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