Descriptive Observational Study of Patient-performed Pre-oxygenation (ApréOx)

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

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".

Study Overview

• Status: Completed
• Conditions: Anesthesia; ASA Physical Status I; ASA Physical Status II
• Intervention / Treatment: Other: APAIS scale; Other: Visual analog anxiety scale (VAS-A); Other: Visual analog comfort scale (VAS-C); Other: Auto-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 Type: Observational
• Enrollment (Actual): 110

Contacts and Locations

Study Locations

• France
  • Île-de-France Region
    • Paris, Île-de-France Region, France, 75014
      • Anesthesia-intensive care department - Cochin - Port-Royal hospital - APHP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Major patient (adults) undergoing scheduled outpatient surgery requiring general anesthesia.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Patients; Adult patients benefiting from planned outpatient surgery under general anesthesia.

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); 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%.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FeO2>90%	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	3 minuts after the beginning of auto-preoxygenation - Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual analog anxiety scale (VAS-A) score	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	At arrival in the Day Surgery Unit - Day 1
Visual analog anxiety scale (VAS-A) score	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	At discharge from the Day Surgery Unit - Day 1
Visual analog comfort scale (VAS-C) score	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	At discharge from the Day Surgery Unit - Day 1
APAIS anxiety score	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	At arrival in the Day Surgery Unit - Day 1

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: URC Necker Cochin, France
• Investigators: Principal Investigator: Sophie TOUSSAINT, Nurse anesthetist, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2024
• Primary Completion (Actual): October 30, 2024
• Study Completion (Actual): October 30, 2024

Study Registration Dates

• First Submitted: April 8, 2024
• First Submitted That Met QC Criteria: April 8, 2024
• First Posted (Actual): April 12, 2024

Study Record Updates

• Last Update Posted (Estimated): September 12, 2025
• Last Update Submitted That Met QC Criteria: September 5, 2025
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Adult; Preoxygenation; General anesthesia; Preoperative anxiety
• Additional Relevant MeSH Terms: argipressin, Asu(1,6)-
• Other Study ID Numbers: APHP240147; 2024-A00143-44 (Other Identifier: France : Ministry of Health)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No