Descriptive Observational Study of Patient-performed Pre-oxygenation

Recruiting

• Conditions: Anesthesia; ASA Physical Status I; ASA Physical Status II
• Interventions: Other: Auto-preoxygenation; Other: APAIS scale; Other: Visual analog anxiety scale (VAS-A); Other: Visual analog comfort scale (VAS-C)

• Registration Number: NCT06361693
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief 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%).

Study Timeline

• Study First Submitted: 2024-04-08
• Study First Submitted QC: 2024-04-08
• Study First Posted: 2024-04-12
• Status Verified: 2024-10
• Study Start: 2024-10-14
• Last Update Submitted: 2024-11-05
• Last Update Posted: 2024-11-07
• Primary Completion: 2025-04
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

• Patient undergoing scheduled surgery with general anesthesia
• Patient classified ASA I or II
• Patient understanding and speaking French
• Patient informed of the study and not opposed to it
• Decision to have preoxygenation carried out by the patient.

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Exclusion Criteria

• Patients with grade II or III obesity (BMI>35)
• Patient with at least one respiratory comorbidity
• Smoking patient
• Pregnant patients
• Patient with an allergy to one of the mask's components
• Patient with cognitive impairment or known comprehension difficulties
• Patient under guardianship or curatorship
• Patient not affiliated to health care system

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients	Visual analog anxiety scale (VAS-A)	Adult patients benefiting from planned outpatient surgery under general anesthesia.
Patients	Auto-preoxygenation	Adult patients benefiting from planned outpatient surgery under general anesthesia.
Patients	APAIS scale	Adult patients benefiting from planned outpatient surgery under general anesthesia.
Patients	Visual analog comfort scale (VAS-C)	Adult patients benefiting from planned outpatient surgery under general anesthesia.

Primary Outcome Measures

Name	Time	Method
FeO2>90%	3 minuts after the beginning of auto-preoxygenation - Day 1	Percentage of patients achieving a FeO2\>90% in 3 min at 12L/min fresh gas flow on 100% oxygen.; To Evaluate the efficacity of the self-preoxygenation Assessing the effectiveness of auto-preoxygenation

Secondary Outcome Measures

Name	Time	Method
APAIS anxiety score	At arrival in the Day Surgery Unit - Day 1	Percentage of patients with a total APAIS anxiety score greater than 10/20 in women, 12/20 in men on arrival in the operating room
Visual analog anxiety scale (VAS-A) score	At discharge from the Day Surgery Unit - Day 1	Percentage of patients with a decrease in the visual analog anxiety scale score (VAS-A) between arrival and discharge in the Day Surgery Unit.; Assessing the effect of self-preoxygenation on preoperative anxiety
Visual analog comfort scale (VAS-C) score	At discharge from the Day Surgery Unit - Day 1	Percentage of patients having obtained a visual analog comfort scale (VAS-C) score greater than 5 out of 10 upon discharge from the Day Surgery Unit.; Assessing the effect of self-preoxygenation on comfort

Trial Locations

Locations (1)

Anesthesia-intensive care department - Cochin - Port-Royal hospital - APHP; 🇫🇷 Paris, Ile de France, France