Impact of Preoxygenation Time on End-tidal Oxygen Concentration and on Hypoxic Events Occurring After Intubation in the Intensive Care Unit.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-31

Study Completion Date

2024-12-31

Brief Summary

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Preoxygenation is recommended before performing tracheal intubation. In intensive care units (ICU) patients, there is no specific recommendation regarding the duration of preoxygenation, which usually is applied for 3 to 5 minutes. Monitoring the effectiveness of preoxygenation with end-tidal oxygen concentration (EtO2) is strongly recommended in the operating room but it is never used in ICUs. The first aim of this pilot study is to assess the effect of the preoxygenation duration on EtO2, and secondarily, as an exploratory objective, to determine whether targeting a given value of EtO2 during preoxygenation might insure a safer intubation than when targeting pulse oximetry (SpO2).

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Detailed Description

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This is a multicenter randomized controlled pilot study. 110 patients who require intubation in the ICU will be randomly assigned, with a 1:1 ratio, to 3 or 5 minutes of preoxygenation duration. EtO2 will be continuously measured but hidden to the clinician. The primary outcome measure will be the obtention of an optimal preoxygenation defined by an EtO2 \>90%. Secondary outcomes include the occurrence of hypoxia and complications during the procedure.

A pulse oximetry (SpO2) greater than or equal to 96% (SpO2 ≥ 96%) at the end of preoxygenation will be the target in each group. If at the end of the preoxygenation, SpO2 is still lower than 96%, clinician will be allowed to extend the duration of preoxygenation (up to 5 minutes in the 3 minutes period of preoxygenation group and up to 8 minutes in the 5 minutes period of preoxygenation group).

End-tidal oxygen concentration (EtO2) will be measured during preoxygenation and will be hidden to the clinician in order to not influence the duration of preoxygenation.

Conditions

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Preoxygenation Intubation Intensive Care Unit

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Pilot study Randomized controlled multicenter trial Ratio 1:1

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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3 minutes period of preoxygenation

3 minutes of preoxygenation : participants in this group will receive 3 minutes of preoxygenation before intubation

Group Type EXPERIMENTAL

Preoxygenation

Intervention Type OTHER

participants will receive 3 minutes of preoxygenation before intubation

5 minutes period of preoxygenation

5 minutes of preoxygenation: participants in this group will receive 5 minutes of preoxygenation before intubation

Group Type EXPERIMENTAL

Preoxygenation (longer)

Intervention Type OTHER

participants will receive 5 minutes of preoxygenation before intubation

Interventions

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Preoxygenation

participants will receive 3 minutes of preoxygenation before intubation

Intervention Type OTHER

Preoxygenation (longer)

participants will receive 5 minutes of preoxygenation before intubation

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients older than 18 years
* Requiring intubation in ICU
* Free express oral and informed consent of the patient or a proxy in case of impossibility for the patient to consent; emergency inclusion possible when legal representatives and patient's family are not present

Exclusion Criteria

* Intubation for cardiac arrest
* End-tidal oxygen concentration monitoring not available
* Preoxygenation with high-flow nasal oxygenation
* Previous participation to the study
* Patient known, at time of inclusion, as being under guardianship, tutorship or curator
* Pregnancy or breastfeeding
* Lack of social security number

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No