Skip to main content
OpenTrials
Completed

NCT Number: NCT06361693

Descriptive Observational Study of Patient-performed Pre-oxygenation

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".

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

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

About this study

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%).

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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%.

APAIS scale

Other

APAIS scale

Visual analog anxiety scale (VAS-A)

Other

Visual analog anxiety scale (VAS-A)

Visual analog comfort scale (VAS-C)

Other

Visual analog comfort scale (VAS-C)

Primary outcomes

  1. FeO2>90%

    Time frame: 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 outcomes

  1. APAIS anxiety score

    Time frame: 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

  2. Visual analog anxiety scale (VAS-A) score

    Time frame: At arrival in 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 anxiety

  3. Visual analog anxiety scale (VAS-A) score

    Time frame: 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 anxiety

  4. Visual analog comfort scale (VAS-C) score

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

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

Acronym: ApréOx

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 12, 2024
Registry last updated
Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.