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

January 31, 2021 updated by: Stefan Kluge, Universitätsklinikum Hamburg-Eppendorf

Prospective Randomised Study on Preoxygenation in the Intensive Care Unit Using a Nose-mouth Mask Versus High Flow Nasal Cannula Oxygen.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hamburg, Germany, 20246
        • Universitätsklinikum Hamburg-Eppendorf, Department of Intensive Care Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Nose-mouth mask
Performance of intubation after preoxygenation using a nose-mouth mask.
Device: Nose-mouth mask
Preoxygenation using a nose-mouth mask.
Procedure: Intubation
Intubation
Experimental: High flow nasal cannula oxygen
Performance of intubation after preoxygenation using high flow nasal cannula oxygen.
Procedure: Intubation
Intubation
Device: High flow nasal cannula oxygen
Preoxygenation using high flow nasal cannula oxygen.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean decrease in the saturation of oxygen (SpO2) during intubation.
Time Frame: during intubation
Mean decrease in the saturation of oxygen measured by pulse oximetry (SpO2 [%]) during intubation.
during intubation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in blood gases after intubation.
Time Frame: 30 minutes after intubation
Changes in arterial blood gases collected from arterial line (PaO2/FiO2 [mmHg] and PaCO2 [mmHg]) after intubation.
30 minutes after intubation

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in hemodynamics.
Time Frame: during intubation and up to 30 minutes after intubation
Changes in mean arterial pressure [mmHg] measured via arterial line.
during intubation and up to 30 minutes after intubation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

November 20, 2013

First Submitted That Met QC Criteria

November 20, 2013

First Posted (Estimate)

November 26, 2013

Study Record Updates

Last Update Posted (Actual)

February 3, 2021

Last Update Submitted That Met QC Criteria

January 31, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PV-4429

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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