Clinical trial NCT02833662: Evaluation of Sleep Apnea and Cardiac Rhythm Abnormalities After Surgery Under General Anesthesia
Official title: Evolution of the Severity of Obstructive Sleep Apnea and Consequences on Cardiac Rhythm Abnormalities After Surgery Under General Anesthesia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obstructive Sleep Apnea
Arrhythmia
Keywords: Hypoxia
Perioperative outcomes
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: AGIR à Dom
First posted: 2016-07-14
Enrollment: 120
Sex: ALL
Minimum age (years): 45
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in heart rhythm troubles linked to hypoxemia events
timeFrame: Before surgery and at first and third night after surgery
Secondary outcomes:
measure: Change from baseline in severity of OSA defined by the oxygen saturation index
timeFrame: Before surgery and at first and third night after surgery
measure: Aggravation of cardiac events linked to hypoxemia
timeFrame: After surgery from night 1 to night 15 maximum
measure: Change from baseline OSA prevalence and cardiorespiratory complications after surgery
timeFrame: Before surgery and at first and third night after surgery
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Grenoble
name: Renaud TAMISIER, Md,PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Seguin L, Tamisier R, Deletombe B, Lopez M, Pepin JL, Payen JF. Preoperative Screening for Obstructive Sleep Apnea Using Alternative Scoring Models of the Sleep Tiredness Observed Pressure-Body Mass Index Age Neck Circumference Gender Questionnaire: An External Validation. Anesth Analg. 2020 Oct;131(4):1025-1031. doi: 10.1213/ANE.0000000000004909.