Evaluation of Sleep Apnea and Cardiac Rhythm Abnormalities After Surgery Under General Anesthesia (Etude3A)

Grenoble Alpes University Hospital Center (CHU)

Status: Unknown

Conditions: Arrhythmia; Obstructive Sleep Apnea

Treatments: Other: Measure of ODI and heart rhythm

Study type: Interventional

Funder types: Other

Identifiers

NCT02833662

38RC15.080

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 45 to 99 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 1 patient group

Patients suspected to present a Sleep Apnea Syndrom

Other group

Description:

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.

Treatment:

Other: Measure of ODI and heart rhythm