NCT04148443

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Centre Hospitalier Régional d'Orléans · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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

• Preoxygenation
• Intubation
• Intensive Care Unit

Interventions

Type	Name	Description
OTHER	Preoxygenation	participants will receive 3 minutes of preoxygenation before intubation
OTHER	Preoxygenation (longer)	participants will receive 5 minutes of preoxygenation before intubation

Timeline

• Start date: 2023-12-01
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2019-11-01
• Last updated: 2024-06-27

Locations

3 sites across 1 country: France