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

Respiratory Failure Clinical Trial

Official title:

Prospective Randomised Study on Preoxygenation in the Intensive Care Unit Using a Nose-mouth Mask Versus High Flow Nasal Cannula Oxygen.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01994928
• Other study ID #: PV-4429
• Status: Completed
• Phase: N/A
• Start date: November 2013
• Est. completion date: November 2014

Study information

• Verified date: January 2021
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Respiratory Failure
• Respiratory Insufficiency

Intervention

Device:
• Nose-mouth mask
Preoxygenation using a nose-mouth mask.
• High flow nasal cannula oxygen
Preoxygenation using high flow nasal cannula oxygen.

Procedure:
• Intubation
Intubation

Locations

Country	Name	City	State
Germany	Universitätsklinikum Hamburg-Eppendorf, Department of Intensive Care Medicine	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. E — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in hemodynamics.	Changes in mean arterial pressure [mmHg] measured via arterial line.	during intubation and up to 30 minutes after intubation
Primary	Mean decrease in the saturation of oxygen (SpO2) during intubation.	Mean decrease in the saturation of oxygen measured by pulse oximetry (SpO2 [%]) during intubation.	during intubation
Secondary	Changes in blood gases after intubation.	Changes in arterial blood gases collected from arterial line (PaO2/FiO2 [mmHg] and PaCO2 [mmHg]) after intubation.	30 minutes after intubation