Clinical trial NCT06779682: Systematic Screening for Obstructive Sleep Apnea During Preoperative Consultation Using AI-preoperative Agents
Official title: Feasibility Study: Systematic Screening for Obstructive Sleep Apnea (OSA) During Preoperative Consultation
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Obstructive Sleep Apnea
Preoperative Evaluation
Keywords: preoperative
STOP-BANG score
Obstructive Sleep Apnea
AI
OSA
Lead sponsor: Intelligence Anesthesia
Sponsor class: INDUSTRY
Collaborators: name: Department of Anesthesiology, Hopital Foch, Suresnes, France.
name: GCS Ramsay Santé pour l'Enseignement et la Recherche
name: Hôpital privé Claude Galien - Quincy-sous-Sénart
First posted: 2025-01-16
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients with a STOP BANG \> 5 or \> 4 associated with an obesity (BMI \> 35 kg/m2)

Brief summary: The goal of this observational study is to evaluate the feasibility of a systematic screening protocol for Obstructive Sleep Apnea (OSA) during preoperative anesthesia consultations in adults aged 50 and older undergoing elective surgery. The main questions it aims to answer are:

* Does the systematic screening protocol increase the proportion of patients identified as being at high risk for OSA compared to standard care?
* What is the impact of systematic screening on postoperative outcomes, including complications, length of stay, and mortality?

Researchers will compare standard care practices (before implementation) to the systematic screening protocol (after implementation) to determine the effect on OSA detection rates and clinical outcomes.

Participants will:

* Complete the STOP-BANG questionnaire during their anesthesia consultation.
* (Optional) Have a facial photograph taken to analyze morphometric characteristics that may correlate with OSA risk.
* Be referred for further diagnostic testing if identified as high-risk for OSA.


Eligibility criteria: Inclusion Criteria:

* All patients with a national health identifier affiliated with the social security system, aged over 18, including French individuals over 50 years old, in scheduled anesthesia consultation with STOP BANG \> 5 or \> 4 with BMI \> 35

Exclusion Criteria:

* Refusal to participate in the study, age under 50, not affiliated with the social security system, minor or under legal protection

Primary outcomes:
measure: proportion of participants in whom the risk of OSA (Obstructive Sleep Apnea Syndrome) was detected in the control group before versus the group after
timeFrame: From enrollment to the end of treatment at 7 months
Secondary outcomes:
measure: Mortality at 3 months.
timeFrame: From enrollment to the end of treatment at 7 months
measure: Postoperative length of stay.
timeFrame: From enrollment to the end of treatment at 7 months
measure: Sensitivity, specificity, and concordance rate of OSA (Obstructive Sleep Apnea Syndrome) detection.
timeFrame: From enrollment to the end of treatment at 7 months
measure: Correlation between facial morphotype and OSA diagnosis with and without facial morphotype measurement.
timeFrame: From enrollment to the end of treatment at 7 months
measure: Postoperative complications and mortality at 3 months.
timeFrame: From enrollment to the end of treatment at 7 months
measure: Postoperative complications
timeFrame: From enrollment to the end of treatment at 7 months
Other outcomes:
Locations:
city: Quincy-sous-senart
country: France
facility: Hopital Privé Claude Galien
Study officials:
References: