Prevention Of Delirium in Elderly With Obstructive Sleep Apnea (PODESA)
- Conditions
- Sleep Apnea
- Interventions
- Other: CPAP treatment
- Registration Number
- NCT02954224
- Lead Sponsor
- University Health Network, Toronto
- Brief Summary
Delirium is a common complication in elderly patients following surgery. Patients who develop delirium after surgery are at increased risk for serious complications, and even death.This multi-centre randomized controlled trial will enroll elderly patients scheduled for elective hip/knee replacement surgery.The objective of this trial is to identify obstructive sleep apnea using ApneaLink Air and to determine whether auto-titrating CPAP treatment of obstructive sleep apnea will decrease the incidence of post-operative delirium in elderly patients undergoing elective hip and knee replacement surgery.
- Detailed Description
Delirium is an acute and fluctuating change in cognitive function, characterized by poor attention and disorganized thinking. Recent studies show that patients with obstructive sleep apnea (OSA) - a sleep disorder characterized by repeated episodes of complete or partial blockage of the upper airway - are at greater risk to develop delirium. It is estimated that 43% of men and 27% of women aged 50-70 years old have OSA. Elderly individuals with this condition are often undiagnosed. Unrecognized OSA may be a treatable cause of postoperative delirium. However, timely access to polysomnography is usually not possible prior to surgery. This multi-centre randomized controlled trial will enroll elderly patients scheduled for elective hip/knee replacement surgery. All participants who have given the consent to participate will be assessed risks of OSA and comorbidity by 3 basic questionnaires- STOP-Bang, Epworth Sleepiness Scale and Charlson Comorbidity index, Cognitive level assess by Mini-Cog and baseline delirium assessment by CAM. STOP-Bang questionnaire is the validated questionnaire to screen the patients for OSA. Score of 3 or higher has sensitivity of detecting OSA of 93% and 100% for moderate and severe OSA respectively. If participant has STOP-Bang score 3 or higher will have a home sleep study with the ApneaLink Air and overnight oximetry. Patients identified to have OSA(AHI ≥10/h) will be randomized to 1) Auto-titrating continuous positive airway pressure (CPAP) applied 1-3 nights before surgery (if possible) and during day/night sleep for 72 hrs after surgery or 2) Control group - routine care. All patients will be evaluated for delirium for 72h after surgery.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 220
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CPAP therapy arm CPAP treatment Auto-titrating Continuous Positive Airway Pressure (CPAP)) treatment will be given on postoperative days 1, 2, and 3.
- Primary Outcome Measures
Name Time Method postoperative delirium 2 MONTHS The primary outcome is the incidence of postoperative delirium.
- Secondary Outcome Measures
Name Time Method Length of Hospital Stay Depending on post operative recovery(2 days-2 months) This parameter depends on post operative recovery
Perioperative Complications 10-14 days Post operative complications include ICU admissions, hypoxia, re-intubation, Myocardial Infarctions, Wound Infections, Deep Vein Thrombosis, Pneumonia, Sepsis, Urinary Tract Infection, Stroke, etc..)
Time to ambulate 1 week to 2 months This parameter depending on lots of factors( eg; physiotherapy, weight, attitudes, other medical conditions ect...)
Trial Locations
- Locations (3)
Toronto Western Hospital
🇨🇦Toronto, Ontario, Canada
Sunnybrook Hospital
🇨🇦Toronto, Ontario, Canada
Mount Sinai Hospital
🇨🇦Toronto, Ontario, Canada