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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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ClinicalTrials.gov Identifier: NCT01994928
Recruitment Status : Completed
First Posted : November 26, 2013
Last Update Posted : February 3, 2021
Sponsor:
Information provided by (Responsible Party):
Stefan Kluge, Universitätsklinikum Hamburg-Eppendorf

Study Description
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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.

Condition or disease Intervention/treatment Phase
Respiratory Failure Device: Nose-mouth mask Device: High flow nasal cannula oxygen Procedure: Intubation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Randomised Study on Preoxygenation in the Intensive Care Unit Using a Nose-mouth Mask Versus High Flow Nasal Cannula Oxygen.
Study Start Date : November 2013
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

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Arms and Interventions
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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.
 Device: High flow nasal cannula oxygen
Preoxygenation using high flow nasal cannula oxygen.

Procedure: Intubation
Intubation


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01994928


Locations
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Germany
Universitätsklinikum Hamburg-Eppendorf, Department of Intensive Care Medicine
Hamburg, Germany, 20246
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
More Information
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Publications of Results:

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Responsible Party: Stefan Kluge, Prof. Dr. Stefan Kluge, Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT01994928    
Other Study ID Numbers: PV-4429
First Posted: November 26, 2013    Key Record Dates
Last Update Posted: February 3, 2021
Last Verified: January 2021
Additional relevant MeSH terms:
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Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases