Observational Study of the Value of Using Obstructive Sleep Apnea-hypopnea Syndrome (CPAP) Ventilation on the Occurrence of Respiratory and Cardiovascular Complications in Patients at High Risk of Obstructive Apnea Syndrome During Postoperative Sleep Surgery of a Major Abdominal Surgery.

Completed

• Conditions: Major Abdominal Surgery

• Registration Number: NCT04345354
• Lead Sponsor: Poitiers University Hospital

Brief Summary

The presence of an obstructive sleep apnea-hypopnea syndrome (OSAHS) is a perfectly identified cardiovascular and metabolic risk factor responsible for excess mortality in patients with severe OSAHS, while life expectancy, when the SAHOS is treated by continuous positive airway pressure (CPAP) is close to that of the general population. It also represents a factor of excess mortality, little known and poorly explored, in relation to morbidity and mortality occurring during the perioperative period accompanying any general anesthesia.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06-14
• Study First Submitted: 2018-08-06
• Primary Completion: 2018-12
• Study Completion: 2018-12
• Status Verified: 2020-04
• Study First Submitted QC: 2020-04-10
• Last Update Submitted: 2020-04-10
• Study First Posted: 2020-04-14
• Last Update Posted: 2020-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• Patients over 18 years old and naive to any treatment with obstructive sleep apnea-hypopnea syndrome,
• Patients at high risk of obstructive sleep apnea-hypopnea syndrome (STOP BANG ≥ 3),
• Patients scheduled for major abdominal surgery (all intraperitoneal surgeries excluding vesicles, eventrations and hernias, all aortic surgeries excluding endovascular surgeries) within a minimum of 10 days,
• It is possible to integrate the explanations concerning the realization of the ApneaLink ™ Air in autonomy and to ensure its restitution under 24-48h,

Exclusion Criteria

• Patients with obstructive sleep apnea-hypopnea syndrome diagnosed before surgery,
• Patients with heart failure (NYHA> II),
• Patients with moderate to severe COPD
• Patients participating in a clinical trial,

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluate rate of respiratory complications with moderate sleep apnea syndrome with continuous positive airway pressure treatment	7 days
Evaluate rate of respiratory complications with moderate sleep apnea syndrome without continuous positive airway pressure treatment	7 days
Evaluate rate of cardiovascular complications with moderate sleep apnea syndrome with continuous positive airway pressure treatment	7 days
Evaluate rate of cardiovascular complications with moderate sleep apnea syndrome without continuous positive airway pressure treatment	7 days

Secondary Outcome Measures

Name	Time	Method
Evaluate the prevalence of obstructive sleep apnea-hypopnea syndrome patients to the severity level of the STOPBANG score,	7 days
Evaluate tolerance and observance of continuous positive airway pressure treatment	7 days
Evaluate the feasibility of the ApneaLink	7 days
Evaluate the duration and place of hospitalization during the post-surgical course	28 days

Trial Locations

Locations (1)

Chu de Poitiers; 🇫🇷 Poitiers, France