NCT06361693

Descriptive Observational Study of Patient-performed Pre-oxygenation

"Observational Descriptive Study of Patient-performed Preoxygenation, the "Autopreoxygenation Concept""

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 110 (actual)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

The aim of this research would be to determine the efficacy and effects of preoxygenation when performed by the patient (mask held by the patient). This is the concept of "self-preoxygenation".

Detailed description

Pre-oxygenation is a fundamental element of the induction sequence in anesthesia, described and recommended since 1955. Numerous studies have examined and compared the various techniques for implementing this procedure in terms of duration, objectives, equipment, patient characteristics and conditions. None of them specifies who should hold the mask when carrying out this recommendation. In everyday practice, patients are often asked to hold the mask themselves. A preliminary survey showed that 86% of patients are offered this option. The professionals questioned cited relational reasons (83%) above all, but also organizational reasons (43%).

Conditions

• Anesthesia
• ASA Physical Status I
• ASA Physical Status II

Interventions

Type	Name	Description
OTHER	Auto-preoxygenation	Management is not modified. Routine monitoring (ECG, BP, SpO2). As in care, the patient takes the mask and the respirator is started, delivering an inspired oxygen fraction of 100% (FiO2=1). Monitoring of : inspired fraction of oxygen, expired fraction of oxygen and end-tidal fraction of carbon dioxide. The ventilator also provides the respiratory rate and tidal volume carried out by the patient. The fresh gas flow is set by default and will be adjusted to 12l/min for patient comfort.After less than a minute, a normal capnia curve and the presence of an FeO2 value appear. Here, time is standardized to 1 min. In the absence of one of these elements, the caregiver always takes control of preoxygenation.Timer is started, it is T0 min. At T 3min, collection of values and decision-making : * objectives achieved : end of this sequence. * objectives not achieved, the caregiver takes control again for an additional 2 minutes in order to seek to achieve an FeO2\>90%.
OTHER	APAIS scale	APAIS scale
OTHER	Visual analog anxiety scale (VAS-A)	Visual analog anxiety scale (VAS-A)
OTHER	Visual analog comfort scale (VAS-C)	Visual analog comfort scale (VAS-C)

Timeline

• Start date: 2024-10-14
• Primary completion: 2024-10-30
• Completion: 2024-10-30
• First posted: 2024-04-12
• Last updated: 2025-09-12

Locations

1 site across 1 country: France