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

NCT ID: NCT01870765

Last Updated: 2020-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2014-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Respiratory Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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non-invasive ventilation

Performance of bronchoscopy during non-invasive ventilation.

Group Type ACTIVE_COMPARATOR

non-invasive ventilation

Intervention Type DEVICE

non-invasive ventilation via face mask

fiberoptic bronchoscopy

Intervention Type PROCEDURE

fiberoptic bronchoscopy including broncho-alveolar lavage

high-flow oxygen

Performance of bronchoscopy during high-flow oxygen therapy.

Group Type EXPERIMENTAL

high-flow oxygen

Intervention Type DEVICE

high-flow oxygen via nasal cannula

fiberoptic bronchoscopy

Intervention Type PROCEDURE

fiberoptic bronchoscopy including broncho-alveolar lavage

Interventions

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non-invasive ventilation

non-invasive ventilation via face mask

Intervention Type DEVICE

high-flow oxygen

high-flow oxygen via nasal cannula

Intervention Type DEVICE

fiberoptic bronchoscopy

fiberoptic bronchoscopy including broncho-alveolar lavage

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role lead

Responsible Party

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Stefan Kluge

PD Dr. Stefan Kluge

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Universitätsklinikum Hamburg-Eppendorf, Department of Intensive Care Medicine

Hamburg, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type RESULT
PMID: 25529351 (View on PubMed)

Other Identifiers

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PV-4442

Identifier Type: -

Identifier Source: org_study_id