Preoxygenation in the Intensive Care Unit Using a Nose-mouth Mask Versus High-flow Nasal Cannula Oxygen.

NCT ID: NCT01994928

Last Updated: 2021-02-03

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

2013-11-30

Study Completion Date

2014-11-30

Brief Summary

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Preoxygenation is routinely performed before endotracheal intubation. In the intensive care unit, preoxygenation is often accomplished using a nose-mouth mask. It seems probable that high flow nasal cannula oxygen, which is used in the treatment of patients with hypoxemic respiratory failure, is equally effective in preventing the development of hypoxemia during intubation. In this prospective randomized study preoxygenation using high flow nasal cannula oxygen is compared with preoxygenation via nose-mouth mask in patients with hypoxemic respiratory failure.

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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Nose-mouth mask

Performance of intubation after preoxygenation using a nose-mouth mask.

Group Type ACTIVE_COMPARATOR

Nose-mouth mask

Intervention Type DEVICE

Preoxygenation using a nose-mouth mask.

Intubation

Intervention Type PROCEDURE

Intubation

High flow nasal cannula oxygen

Performance of intubation after preoxygenation using high flow nasal cannula oxygen.

Group Type EXPERIMENTAL

High flow nasal cannula oxygen

Intervention Type DEVICE

Preoxygenation using high flow nasal cannula oxygen.

Intubation

Intervention Type PROCEDURE

Intubation

Interventions

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Nose-mouth mask

Preoxygenation using a nose-mouth mask.

Intervention Type DEVICE

High flow nasal cannula oxygen

Preoxygenation using high flow nasal cannula oxygen.

Intervention Type DEVICE

Intubation

Intubation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* patients treated in an intensive care unit
* indication for intubation
* presence of hypoxemic (SaO2/fraction of inspired oxygen(FiO2): 300 or less) respiratory failure
* informed consent

Exclusion Criteria

* blocked nasopharynx
* contraindications for nose-mouth mask or high flow nasal cannula oxygen
* expected difficult airway
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

Prof. 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, Wachs C, Braune S, de Heer G, Frings D, Kluge S. High-Flow Nasal Cannula Versus Bag-Valve-Mask for Preoxygenation Before Intubation in Subjects With Hypoxemic Respiratory Failure. Respir Care. 2016 Sep;61(9):1160-7. doi: 10.4187/respcare.04413. Epub 2016 Jun 7.

Reference Type RESULT
PMID: 27274092 (View on PubMed)

Other Identifiers

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PV-4429

Identifier Type: -

Identifier Source: org_study_id

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