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NCT06361693·Not applicable·OBSERVATIONAL

Descriptive Observational Study of Patient-performed Pre-oxygenation

VasopressinBrain healthCompleted

Status

Completed

Phase

Not applicable

Enrollment

110

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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".

Full 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

Treatment arms and agents.

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%.

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)

Timeline

From registration to results.

  1. First posted

    Apr 12, 2024

  2. Study start

    Oct 14, 2024

  3. Primary completion

    Oct 30, 2024

  4. Study completion

    Oct 30, 2024

  5. Results posted

    Not reported

  6. Registry updated

    Sep 12, 2025

Outcomes

What the study measures.

Primary outcomes

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

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

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

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

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

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
Not reported

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 locations

1 registered sites.

France. Showing up to 24 locations stored in the fast local snapshot.

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

Paris, Île-de-France Region, France

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

ClinicalTrials.gov ↗Search PubMed ↗Search FDA ↗Search EMA ↗

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