This trial is active, not recruiting.

Condition obstructive sleep apnea
Treatments semi-upright position, supine position
Sponsor University Health Network, Toronto
Start date July 2011
End date December 2016
Trial size 56 participants
Trial identifier NCT02152202, Protocol version july 17, 2011


Our main objective is to perform an explanatory, first stage proof of concept, randomized controlled trial to determine whether a semi-upright patient position versus a supine position while asleep in the postoperative period helps decrease the worsening of AHI in patients diagnosed with OSA and compare this to usual care (i.e. supine patient positioning while asleep).

The investigators will evaluate whether a semi-upright position reduces: worsening of AHI (as measured with a portable PSG) on the second postoperative night (POD2); oxygen desaturation index (using a portable oxygen saturation monitor, oxygen desaturation defined as >4% change below baseline lasting for 10 seconds); REM sleep related change in AHI at baseline and POD2.; major and minor perioperative complications on postoperative day POD1, POD2, at discharge and POD 30.; length of hospital stay and readmission within 30 days; and patient satisfaction score on POD30

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model single group assignment
Masking single blind (subject)
Primary purpose treatment
Semi-upright position defined as 45 degrees incline from horizontal of the patients bed during nocturnal sleep, for two postoperative nights. Daytime naps will be excluded. A regular pillow may be used by the patients based upon the level of comfort and also to support the head in a neutral position.
semi-upright position Semi-upright position (45 degree bed angle)
In this group patients' bed will be set into 45 degree angle during sleep in the night time.
In this group patients' bed will be set into Supine/0 degree angle during sleep in the night time. Patient will be managed according to routine care
supine position Control group
Control: Supine position during nocturnal sleep for at least two postoperative nights.

Primary Outcomes

Comparison of worsening of severity of OSA using the Apnea-hypopnea index (AHI) as determined by a portable polysomnography study from baseline (preoperatively) to the second postoperative night.
time frame: 3days

Secondary Outcomes

Major and minor perioperative complications and length of hospital stay on postoperative day (POD) 1, POD2, at discharge and POD 30 will be recorded based on chart review.
time frame: 30 days
Hospital stay
time frame: 30 days

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Adult patients (18 years and above), - ASA physical status I to IV, - Undergoing elective inpatient surgery with obstructive sleep apnea (as determined by initial screening using STOP-Bang questionnaire and if at high risk (>3 points), - Confirmed by an Apnea-hypopnea index (AHI) >5 using a diagnostic home portable polysomnography) Exclusion Criteria: - Patients previously diagnosed as OSA and on continuous positive airway pressure (CPAP) device; - Known cervical, shoulder, spine abnormalities, and/or chronic pain predisposing to difficulty in maintaining a sitting position; or - Previous intervention for OSA (e.g., uvulopalatopharyngoplasty, bariatric surgery); where sitting position is contraindicated postoperatively such as hip or spine surgery, hemodynamic instability; ambulatory surgery i.e. planned discharge on the same day of surgery.

Additional Information

Official title Does a Semi-upright Position During Sleep Prevent Worsening of Severity of Obstructive Sleep Apnea (OSA) on the Second Postoperative Night in Patients Following Elective Inpatient Surgery? A Two Arm, Parallel, Randomized, Controlled, First Stage Proof of Concept Trial
Principal investigator Frances Chung, MD
Description The proposed study is to determine whether patient positioning in supine or semi-sitting position can effectively control the worsening of OSA see in the postoperative period. The study patient will be randomized to semi-sitting position (45 degrees incline) group or supine (0 degrees incline) group. Patients will undergo a portable sleep study on the first or second postoperative night. They will also be monitored with wristwatch oximeter pre and postoperatively according to the study protocol. Patients will be managed according to the routine care determined by the health care team. There will be no change in the clinical management of patients.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University Health Network, Toronto.