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

• Sponsor: Universitätsklinikum Hamburg-Eppendorf (Other)
• Overall Status: Completed
• CT.gov ID: NCT01994928
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Duration (Months): 12
• Patients Per Site Per Month: 3.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Respiratory Failure	Device: Nose-mouth mask; Device: High flow nasal cannula oxygen; Procedure: Intubation	N/A

Study Design

• Study Type: Interventional
• 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: Nov 1, 2013
• Actual Primary Completion Date: Nov 1, 2014
• Actual Study Completion Date: Nov 1, 2014

Arms and Interventions

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

Primary Outcome Measures

1. 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

1. 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.

Other Outcome Measures

1. Changes in hemodynamics. [during intubation and up to 30 minutes after intubation]

   Changes in mean arterial pressure [mmHg] measured via arterial line.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universitätsklinikum Hamburg-Eppendorf, Department of Intensive Care Medicine	Hamburg		Germany	20246

Sponsors and Collaborators

• Universitätsklinikum Hamburg-Eppendorf

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Stefan Kluge, Prof. Dr. Stefan Kluge, Universitätsklinikum Hamburg-Eppendorf
• ClinicalTrials.gov Identifier: NCT01994928
• Other Study ID Numbers: PV-4429
• First Posted: Nov 26, 2013
• Last Update Posted: Feb 3, 2021
• Last Verified: Jan 1, 2021

• Additional relevant MeSH terms: Respiratory Insufficiency

Study Results

No Results Posted as of Feb 3, 2021