AnesthesiaApréOxNCT06361693
Descriptive Observational Study of Patient-performed Pre-oxygenation
An observational study of Anesthesia and ASA Physical Status I, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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". Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia, ASA Physical Status I, ASA Physical Status II
- What is being tested?
- Auto-preoxygenation, APAIS scale and Visual analog anxiety scale (VAS-A)
- How many people
- 110 participants
- Where
- 1 siteFrance
- Study dates
- 14 Oct 2024to 30 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Major patient (adults) undergoing scheduled outpatient surgery requiring general anesthesia.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Anesthesia-intensive care department - Cochin - Port-Royal hospital - APHP
Paris, Île-de-France Region, 75014
About this study
Official title: "Observational Descriptive Study of Patient-performed Preoxygenation, the "Autopreoxygenation Concept""
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".
Read the 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
- Being tested
- Auto-preoxygenation, APAIS scale, Visual analog anxiety scale (VAS-A), Visual analog comfort scale (VAS-C)
- Keywords
- Preoxygenation, General anesthesia, Adult, Preoperative anxiety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auto-preoxygenationOther
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 scaleOther
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)
| Study group | Role | What they receive |
|---|---|---|
| Patients | Adult patients benefiting from planned outpatient surgery under general anesthesia. Receives: Other: Auto-preoxygenation; Other: APAIS scale; Other: Visual analog anxiety scale (VAS-A); Other: Visual analog comfort scale (VAS-C) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 minuts after the beginning of auto-preoxygenation - Day 1
Secondary outcomes (4)
APAIS anxiety score
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
Measured: At arrival in the Day Surgery Unit - Day 1
Visual analog anxiety scale (VAS-A) score
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
Measured: At arrival in the Day Surgery Unit - Day 1
Visual analog anxiety scale (VAS-A) score
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
Measured: At discharge from the Day Surgery Unit - Day 1
Visual analog comfort scale (VAS-C) score
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
Measured: At discharge from the Day Surgery Unit - Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2024
- Study start14 Oct 2024
- Primary completion30 Oct 2024
- Study completion30 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Sophie TOUSSAINT, Nurse anesthetist, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06361693
- Sponsor's protocol ID
- APHP240147
- Other IDs
- 2024-A00143-44
- Acronym
- ApréOx
- Status last verified
- Sep 2024
- First submitted
- 8 Apr 2024
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Observational Descriptive Study of Patient-performed Preoxygenation, the "Autopreoxygenation Concept""
- ClinicalTrials.gov ID
- NCT06361693
- Acronym / sponsor ID
- ApréOx / APHP240147
- Conditions
- Anesthesia, ASA Physical Status I, ASA Physical Status II
- Keywords
- Preoxygenation, General anesthesia, Adult, Preoperative anxiety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 14 Oct 2024 (actual)
- Primary completion
- 30 Oct 2024 (actual)
- Study completion
- 30 Oct 2024 (actual)
- First posted
- 12 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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%).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: Auto-preoxygenation, Other: APAIS scale, Other: Visual analog anxiety scale (VAS-A), Other: Visual analog comfort scale (VAS-C)Adult patients benefiting from planned outpatient surgery under general anesthesia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Major patient (adults) undergoing scheduled outpatient surgery requiring general anesthesia.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Auto-preoxygenationManagement 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 | Patients |
| APAIS scaleAPAIS scale | Other | Patients |
| Visual analog anxiety scale (VAS-A)Visual analog anxiety scale (VAS-A) | Other | Patients |
| Visual analog comfort scale (VAS-C)Visual analog comfort scale (VAS-C) | Other | Patients |
Primary outcome
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
4 secondary outcomes
APAIS anxiety score
Time frame: At arrival in the Day Surgery Unit - Day 1
Visual analog anxiety scale (VAS-A) score
Time frame: At arrival in the Day Surgery Unit - Day 1
Visual analog anxiety scale (VAS-A) score
Time frame: At discharge from the Day Surgery Unit - Day 1
Visual analog comfort scale (VAS-C) score
Time frame: At discharge from the Day Surgery Unit - Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sophie TOUSSAINT, Nurse anesthetist principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia and ASA Physical Status I, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FeO2>90% (time frame: 3 minuts after the beginning of auto-preoxygenation - Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025.