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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01994928

Enrollment

Registered

2013-11-26

Start date

2013-11-30

Completion date

2014-11-30

Last updated

2021-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Failure

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.

Interventions

DEVICENose-mouth mask

Preoxygenation using a nose-mouth mask.

DEVICEHigh flow nasal cannula oxygen

Preoxygenation using high flow nasal cannula oxygen.

PROCEDUREIntubation

Intubation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Measure	Time frame	Description
Changes in hemodynamics.	during intubation and up to 30 minutes after intubation	Changes in mean arterial pressure \[mmHg\] measured via arterial line.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026