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.

Major Abdominal Surgery Clinical Trial

— APNOSIS-BIS  

Official title:

Observational Study of the Value of Using Continuous Positive Airway Pressure (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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04345354
• Other study ID #: APNOSIS-BIS
• Status: Completed
• Start date: June 14, 2016
• Est. completion date: December 2018

Study information

• Verified date: April 2020
• Source: Poitiers University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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,

Related Conditions & MeSH terms

• Major Abdominal Surgery
• Sleep Apnea, Obstructive

Locations

Country	Name	City	State
France	Chu de Poitiers	Poitiers

Sponsors (1)

Lead Sponsor	Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate rate of respiratory complications with moderate sleep apnea syndrome with continuous positive airway pressure treatment		7 days
Primary	Evaluate rate of respiratory complications with moderate sleep apnea syndrome without continuous positive airway pressure treatment		7 days
Primary	Evaluate rate of cardiovascular complications with moderate sleep apnea syndrome with continuous positive airway pressure treatment		7 days
Primary	Evaluate rate of cardiovascular complications with moderate sleep apnea syndrome without continuous positive airway pressure treatment		7 days
Secondary	Evaluate tolerance and observance of continuous positive airway pressure treatment		7 days
Secondary	Evaluate the feasibility of the ApneaLink		7 days
Secondary	Evaluate the prevalence of obstructive sleep apnea-hypopnea syndrome patients to the severity level of the STOPBANG score,		7 days
Secondary	Evaluate the duration and place of hospitalization during the post-surgical course		28 days