Evaluation of Sleep Apnea and Cardiac Rhythm Abnormalities After Surgery Under General Anesthesia

Not Applicable

• Conditions: Arrhythmia; Obstructive Sleep Apnea
• Interventions: Other: Measure of ODI and heart rhythm

• Registration Number: NCT02833662
• Lead Sponsor: University Hospital, Grenoble

Brief Summary

Higher risk of cardiac and respiratory post-operative events is observed in patients with unrecognised Obstructive Sleep Apnea (OSA). The efficiency of a simple method of OSA screening by analysing ventilation with measurement of nose pressure and nocturnal hypoxemia (oxygen desaturation index) will be assessed. These sleep respiratory analyses will be compared with the research of arrhythmia, in order to show if they are linked to the hypoxemia events.

Aggravation of nocturnal respiratory disorder and higher incidence of cardiac and respiratory postoperative complications will be assessed in OSA patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-06-03
• Status Verified: 2016-05
• Study First Submitted QC: 2016-07-12
• Last Update Submitted: 2016-07-12
• Study First Posted: 2016-07-14
• Last Update Posted: 2016-07-14
• Primary Completion: 2016-12
• Study Completion: 2017-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• orthopaedic, urologic, vascular, digestive surgery
• under general anaesthesia or sedation
• age > 45 years old
• STOP-BANG score>3

Exclusion Criteria

• Head and neck surgery, planned prolonged mechanical ventilation after surgery (>24h)
• Severe COPD
• Post-operative ICU planned
• Diagnosed OSA or other sleep disorder breathing

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients suspected to present a Sleep Apnea Syndrom	Measure of ODI and heart rhythm	Record nocturnal respiratory and cardiac parameters before and after surgery : Severity of sleep respiratory disorders and relationship with cardiac rhythm abnormalities will be assessed in patients suspected to present Sleep Apnea, before and after surgery under general anesthesia.

Primary Outcome Measures

Name	Time	Method
Change from baseline in heart rhythm troubles linked to hypoxemia events	Before surgery and at first and third night after surgery	Heart rhythm troubles will be assessed 3 times: * First time = baseline assessment, during one night before surgery; * second assessment will occur during the first night after surgery; * last assessment will take place during the third night after surgery

Secondary Outcome Measures

Name	Time	Method
Aggravation of cardiac events linked to hypoxemia	After surgery from night 1 to night 15 maximum
Change from baseline OSA prevalence and cardiorespiratory complications after surgery	Before surgery and at first and third night after surgery
Change from baseline in severity of OSA defined by the oxygen saturation index	Before surgery and at first and third night after surgery	OSA will be assessed 3 times: * First time = baseline assessment, during one night before surgery; * second assessment will occur during the first night after surgery; * last assessment will take place during the third night after surgery oxygen saturation index \> 10 mandatory for the study oxygen saturation index \> 40 : result qualified severe