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

Arm | Intervention/treatment |
---|---|
Active Comparator: Nose-mouth mask
Performance of intubation after preoxygenation using a nose-mouth mask.
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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.
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Device: High flow nasal cannula oxygen
Preoxygenation using high flow nasal cannula oxygen. Procedure: Intubation Intubation |
- 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.
- 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.
- Changes in hemodynamics. [ Time Frame: during intubation and up to 30 minutes after intubation ]Changes in mean arterial pressure [mmHg] measured via arterial line.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
Germany | |
Universitätsklinikum Hamburg-Eppendorf, Department of Intensive Care Medicine | |
Hamburg, Germany, 20246 |
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 |
Respiratory Insufficiency Respiration Disorders Respiratory Tract Diseases |