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

Not Applicable

Completed

• Conditions: Respiratory Failure
• Interventions: Device: High flow nasal cannula oxygen; Device: Nose-mouth mask; Procedure: Intubation

• Registration Number: NCT01994928
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2013-11-20
• Study First Submitted QC: 2013-11-20
• Study First Posted: 2013-11-26
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-31
• Last Update Posted: 2021-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High flow nasal cannula oxygen	High flow nasal cannula oxygen	Performance of intubation after preoxygenation using high flow nasal cannula oxygen.
Nose-mouth mask	Nose-mouth mask	Performance of intubation after preoxygenation using a nose-mouth mask.
High flow nasal cannula oxygen	Intubation	Performance of intubation after preoxygenation using high flow nasal cannula oxygen.
Nose-mouth mask	Intubation	Performance of intubation after preoxygenation using a nose-mouth mask.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Changes in blood gases after intubation.	30 minutes after intubation	Changes in arterial blood gases collected from arterial line (PaO2/FiO2 \[mmHg\] and PaCO2 \[mmHg\]) after intubation.

Trial Locations

Locations (1)

Universitätsklinikum Hamburg-Eppendorf, Department of Intensive Care Medicine; 🇩🇪 Hamburg, Germany