Clinical trial NCT06361693: Descriptive Observational Study of Patient-performed Pre-oxygenation
Official title: "Observational Descriptive Study of Patient-performed Preoxygenation, the "autopreoxygenation Concept""
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Anesthesia
ASA Physical Status I
ASA Physical Status II
Keywords: Preoxygenation
General anesthesia
Adult
Preoperative anxiety
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2024-04-12
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Major patient (adults) undergoing scheduled outpatient surgery requiring general anesthesia.

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%).

Eligibility criteria: 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.

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

Primary outcomes:
measure: FeO2>90%
timeFrame: 3 minuts after the beginning of auto-preoxygenation - Day 1
Secondary outcomes:
measure: APAIS anxiety score
timeFrame: At arrival in the Day Surgery Unit - Day 1
measure: Visual analog anxiety scale (VAS-A) score
timeFrame: At arrival in the Day Surgery Unit - Day 1
measure: Visual analog anxiety scale (VAS-A) score
timeFrame: At discharge from the Day Surgery Unit - Day 1
measure: Visual analog comfort scale (VAS-C) score
timeFrame: At discharge from the Day Surgery Unit - Day 1
Other outcomes:
Locations:
city: Paris
country: France
facility: Anesthesia-intensive care department - Cochin - Port-Royal hospital - APHP
state: Ile de France
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Sophie TOUSSAINT, Nurse anesthetist
role: PRINCIPAL_INVESTIGATOR
References: