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.

NCT04345354 | Completed

• 1 other identifier: APNOSIS-BIS
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Abdominal Surgery

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Evaluate tolerance and observance of continuous positive airway pressure treatment

  7 days

• Evaluate the feasibility of the ApneaLink

  7 days

• Evaluate the prevalence of obstructive sleep apnea-hypopnea syndrome patients to the severity level of the STOPBANG score,

  7 days

• Evaluate the duration and place of hospitalization during the post-surgical course

  28 days

Study Arms (2)

Patient with continuous positive airway pressure treatment

without continuous positive airway pressure treatment

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients without known obstructive sleep apnea-hypopnea syndrome, presenting at anesthesia consultation for visceral surgery to be performed at least within 10 days.

You may qualify if:

• 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,

You may not qualify if:

• 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,

Sponsors & Collaborators

• Poitiers University Hospital: lead

Study Sites (1)

Chu de Poitiers

Poitiers, 86021, France

Location

Study Officials

• Jean-Claude MEURICE

  Poitiers University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2018
• First Posted: April 14, 2020
• Study Start: June 14, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: April 14, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)