Descriptive Observational Study of Patient-performed Pre-oxygenation

NCT ID: NCT06361693

Last Updated: 2025-09-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 110 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-10-14
• Study Completion Date: 2024-10-30

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%).

Conditions

Anesthesia; ASA Physical Status I; ASA Physical Status II

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients

Adult patients benefiting from planned outpatient surgery under general anesthesia.

Auto-preoxygenation

Intervention Type: OTHER

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%.

APAIS scale

Intervention Type: OTHER

APAIS scale

Visual analog anxiety scale (VAS-A)

Intervention Type: OTHER

Visual analog anxiety scale (VAS-A)

Visual analog comfort scale (VAS-C)

Intervention Type: OTHER

Visual analog comfort scale (VAS-C)

Interventions

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%.

Intervention Type: OTHER

APAIS scale

APAIS scale

Intervention Type: OTHER

Visual analog anxiety scale (VAS-A)

Visual analog anxiety scale (VAS-A)

Intervention Type: OTHER

Visual analog comfort scale (VAS-C)

Visual analog comfort scale (VAS-C)

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

URC-CIC Paris Descartes Necker Cochin

OTHER

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sophie TOUSSAINT, Nurse anesthetist

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Anesthesia-intensive care department - Cochin - Port-Royal hospital - APHP

Paris, Île-de-France Region, France

Countries

France

Other Identifiers

2024-A00143-44

Identifier Type: OTHER

Identifier Source: secondary_id

APHP240147

Identifier Type: -

Identifier Source: org_study_id