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Descriptive Observational Study of Patient-performed Pre-oxygenation

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06361693
Acronym
ApréOx
Enrollment
110
Registered
2024-04-12
Start date
2024-10-14
Completion date
2024-10-30
Last updated
2025-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, ASA Physical Status I, ASA Physical Status II

Keywords

Preoxygenation, General anesthesia, Adult, Preoperative anxiety

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%).

Interventions

OTHERAuto-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%.

OTHERAPAIS scale

APAIS scale

OTHERVisual analog anxiety scale (VAS-A)

Visual analog anxiety scale (VAS-A)

OTHERVisual analog comfort scale (VAS-C)

Visual analog comfort scale (VAS-C)

Sponsors

URC-CIC Paris Descartes Necker Cochin
CollaboratorOTHER
Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
FeO2>90%3 minuts after the beginning of auto-preoxygenation - Day 1Percentage 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

MeasureTime frameDescription
APAIS anxiety scoreAt arrival in the Day Surgery Unit - Day 1Percentage 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) scoreAt arrival in the Day Surgery Unit - Day 1Percentage 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
Visual analog comfort scale (VAS-C) scoreAt discharge from the Day Surgery Unit - Day 1Percentage 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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026