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

Primary Purpose

Respiratory Failure

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Nose-mouth mask
High flow nasal cannula oxygen
Intubation
Sponsored by
Universitätsklinikum Hamburg-Eppendorf
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Universitätsklinikum Hamburg-Eppendorf, Department of Intensive Care Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Nose-mouth mask

High flow nasal cannula oxygen

Arm Description

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

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

Outcomes

Primary Outcome Measures

Mean decrease in the saturation of oxygen (SpO2) during intubation.
Mean decrease in the saturation of oxygen measured by pulse oximetry (SpO2 [%]) during intubation.

Secondary Outcome Measures

Changes in blood gases after intubation.
Changes in arterial blood gases collected from arterial line (PaO2/FiO2 [mmHg] and PaCO2 [mmHg]) after intubation.

Full Information

First Posted
November 20, 2013
Last Updated
January 31, 2021
Sponsor
Universitätsklinikum Hamburg-Eppendorf
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1. Study Identification

Unique Protocol Identification Number
NCT01994928
Brief Title
Preoxygenation in the Intensive Care Unit Using a Nose-mouth Mask Versus High-flow Nasal Cannula Oxygen.
Official Title
Prospective Randomised Study on Preoxygenation in the Intensive Care Unit Using a Nose-mouth Mask Versus High Flow Nasal Cannula Oxygen.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitätsklinikum Hamburg-Eppendorf

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nose-mouth mask
Arm Type
Active Comparator
Arm Description
Performance of intubation after preoxygenation using a nose-mouth mask.
Arm Title
High flow nasal cannula oxygen
Arm Type
Experimental
Arm Description
Performance of intubation after preoxygenation using high flow nasal cannula oxygen.
Intervention Type
Device
Intervention Name(s)
Nose-mouth mask
Intervention Description
Preoxygenation using a nose-mouth mask.
Intervention Type
Device
Intervention Name(s)
High flow nasal cannula oxygen
Intervention Description
Preoxygenation using high flow nasal cannula oxygen.
Intervention Type
Procedure
Intervention Name(s)
Intubation
Intervention Description
Intubation
Primary Outcome Measure Information:
Title
Mean decrease in the saturation of oxygen (SpO2) during intubation.
Description
Mean decrease in the saturation of oxygen measured by pulse oximetry (SpO2 [%]) during intubation.
Time Frame
during intubation
Secondary Outcome Measure Information:
Title
Changes in blood gases after intubation.
Description
Changes in arterial blood gases collected from arterial line (PaO2/FiO2 [mmHg] and PaCO2 [mmHg]) after intubation.
Time Frame
30 minutes after intubation
Other Pre-specified Outcome Measures:
Title
Changes in hemodynamics.
Description
Changes in mean arterial pressure [mmHg] measured via arterial line.
Time Frame
during intubation and up to 30 minutes after intubation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Universitätsklinikum Hamburg-Eppendorf, Department of Intensive Care Medicine
City
Hamburg
ZIP/Postal Code
20246
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
27274092
Citation
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.
Results Reference
result

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

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