Descriptive Observational Study of Patient-performed Pre-oxygenation

NCT06361693 | Completed

• 2 other identifiers: APHP2401472024-A00143-44
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

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".

Conditions

Anesthesia; ASA Physical Status I; ASA Physical Status II

Keywords

Preoxygenation; General anesthesia; Adult; Preoperative anxiety

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• APAIS anxiety score

  At arrival in the Day Surgery Unit - Day 1

• Visual analog anxiety scale (VAS-A) score

  At arrival in the Day Surgery Unit - Day 1

• Visual analog anxiety scale (VAS-A) score

  At discharge from the Day Surgery Unit - Day 1

• Visual analog comfort scale (VAS-C) score

  At discharge from the Day Surgery Unit - Day 1

Study Arms (1)

Patients

Adult patients benefiting from planned outpatient surgery under general anesthesia.

Other: Auto-preoxygenation; Other: APAIS scale; Other: Visual analog anxiety scale (VAS-A); Other: Visual analog comfort scale (VAS-C)

Interventions

Auto-preoxygenation 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%.

Patients

APAIS scale OTHER

APAIS scale

Patients

Visual analog anxiety scale (VAS-A) OTHER

Visual analog anxiety scale (VAS-A)

Patients

Visual analog comfort scale (VAS-C) OTHER

Visual analog comfort scale (VAS-C)

Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

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

Paris, Île-de-France Region, 75014, France

Location

MeSH Terms

Interventions

argipressin, Asu(1,6)-

Study Officials

• Sophie TOUSSAINT, Nurse anesthetist

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2024
• First Posted: April 12, 2024
• Study Start: October 14, 2024
• Primary Completion: October 30, 2024
• Study Completion: October 30, 2024
• Last Updated: September 12, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)