Descriptive Observational Study of Patient-performed Pre-oxygenation
- Conditions
- AnesthesiaASA Physical Status IASA Physical Status II
- 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%).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 110
- 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.
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- 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 anxietyVisual 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
Related Research Topics
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Trial Locations
- Locations (1)
Anesthesia-intensive care department - Cochin - Port-Royal hospital - APHP
🇫🇷Paris, Ile de France, France
Anesthesia-intensive care department - Cochin - Port-Royal hospital - APHP🇫🇷Paris, Ile de France, FranceSophie TOUSSAINT, Nurse anesthetistContact00 33 1 58 41 45 17sophie.toussaint@aphp.frClaude LE STANG, Nurse anesthetistContactcch.grouperecherche@gmail.comChristophe BAILLARD, PUPHContact