Obstructive Sleep Apnea Clinical Trial
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
Verified date | May 2016 |
Source | University Health Network, Toronto |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 164 |
Est. completion date | December 2016 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Canada | Mount Sinai Hospital, Department of Anesthesia | Toronto | Ontario |
Canada | Toronto Western Hospital, Department of Aneshtesia | Toronto | Ontario |
Canada | Toronto Western Hospital, Department of Aneshtesia | Toronto | Ontario |
Canada | University Health Network, Department of Anesthesia | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
University Health Network, Toronto |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | The AHI is used as a surrogate outcome to establish the diagnosis of OSA (AHI>5) and severity of OSA as per the guidelines from American Academy of Sleep Physicians (AASP).5 It is a continuous outcome and is measured by counting the number of apneas (complete cessation of airflow for more than 10 s) and hypopneas (airflow reduction more than 50%) despite continuing breathing efforts and thus differentiating from central events (absence of breathing efforts). The relationship of AHI to clinical outcomes of relevance has been well established in the literature. | 3days | |
Secondary | 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. | The oxygen desaturation index; REM sleep related change in AHI at baseline and POD2 and time spent in lateral position while asleep will be deciphered from the PSG data. | 30 days | |
Secondary | Hospital stay | Length of hospital stay, readmission within 30 days, and patient satisfaction score will be recorded and telephonic interview with the patient on POD30. | 30 days |
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