Systematic Screening for Obstructive Sleep Apnea During Preoperative Consultation Using AI-preoperative Agents

NCT06779682 | Active Not Recruiting

• 1 other identifier: 2020-A01959-30
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea; Preoperative Evaluation

Keywords

preoperative; STOP-BANG score; Obstructive Sleep Apnea; AI; OSA

Outcome Measures

Primary Outcomes (1)

• proportion of participants in whom the risk of OSA (Obstructive Sleep Apnea Syndrome) was detected in the control group before versus the group after

  From enrollment to the end of treatment at 7 months

Secondary Outcomes (6)

• Mortality at 3 months.

  From enrollment to the end of treatment at 7 months

• Postoperative length of stay.

  From enrollment to the end of treatment at 7 months

• Sensitivity, specificity, and concordance rate of OSA (Obstructive Sleep Apnea Syndrome) detection.

  From enrollment to the end of treatment at 7 months

• Correlation between facial morphotype and OSA diagnosis with and without facial morphotype measurement.

  From enrollment to the end of treatment at 7 months

• Postoperative complications and mortality at 3 months.

  From enrollment to the end of treatment at 7 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients with a STOP BANG \> 5 or \> 4 associated with an obesity (BMI \> 35 kg/m2)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Intelligence Anesthesia: lead
• Department of Anesthesiology, Hopital Foch, Suresnes, France.: collaborator
• GCS Ramsay Santé pour l'Enseignement et la Recherche: collaborator
• Hôpital privé Claude Galien - Quincy-sous-Sénart: collaborator

Study Sites (1)

Hopital Privé Claude Galien

Quincy-sous-Sénart, 91480, France

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2025
• First Posted: January 16, 2025
• Study Start: December 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: September 1, 2025
• Last Updated: January 17, 2025

Record last verified: 2025-01

Locations

FR (1)