Prevention Of Delirium in Elderly With Obstructive Sleep Apnea (PODESA)

NCT02954224 | Completed DMC

• 1 other identifier: 2014-0122-B
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 3

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.

Conditions

Sleep Apnea

Keywords

sleep apnea, delirium

Outcome Measures

Primary Outcomes (1)

• postoperative delirium

  The primary outcome is the incidence of postoperative delirium.

  2 MONTHS

Secondary Outcomes (3)

• Length of Hospital Stay

  Depending on post operative recovery(2 days-2 months)

• Time to ambulate

  1 week to 2 months

• Perioperative Complications

  10-14 days

Study Arms (2)

CPAP therapy arm

EXPERIMENTAL

Auto-titrating Continuous Positive Airway Pressure (CPAP)) treatment will be given on postoperative days 1, 2, and 3.

Other: CPAP treatment

Control arm

NO INTERVENTION

no auto-titrating CPAP, standard care

Interventions

CPAP treatment OTHER

Patients who are randomized to auto-titrating CPAP will use an auto CPAP device on postoperative days 1, 2, and 3

CPAP therapy arm

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age more than 60 years, Scheduled for elective hip or knee replacement surgery at least 4 working days after the preadmission clinic visit
• Possess cognitive and physical capability necessary to comprehend and complete the study questionnaires
• Proficient in English, reading level at Grade 6 (patient or accompanying person),
• Be accessible for follow-up via telephone, or via the Internet, Ability to provide informed consent

You may not qualify if:

• Conditions potentially interfering with comprehension and delivery of informed consent , Schizophrenia, anxiety disorders, poorly controlled depression, multiple psychiatric disorders
• Active psychosis within the last 3 months
• Current use of antipsychotic medication
• Dementia, and/or clinically significant neurological disorder (stroke, epilepsy, brain tumors, Parkinson's Disease etc.)
• History of drug or alcohol dependence or abuse within last 3 months
• Surgery that is two-staged involving more than one surgical procedure to be performed within the same hospitalization period
• Emergency surgery when preoperative testing is not possible
• Patients with prior diagnosis of sleep-related breathing disorder with CPAP treatment
• Patients who may have had sleep studies earlier may be included, if they have been lost to follow-up by a sleep physician, are not on treatment or are non-compliant to treatment (mean CPAP nightly use \<4 hours, or median nightly CPAP use \<50% of total sleep time),Severe tracheal or lung disease,Contraindication to CPAP face-mask, Central Sleep Apnea, Significant Cardiac disease(New York Heart Association Functional Class III and IV Severe Valvular Heart Disease, Dilated Cardiomyopathy, Implanted Cardiac Pacemaker, unstable angina)
• bMyocardial Infarction or Cardiac Surgery or Percutaneous coronary interventions within 3 months

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (3)

Sunnybrook Hospital

Toronto, Ontario, M4N 3M5, Canada

Location

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

Mount Sinai Hospital

Toronto, Ontario, Canada

Location

Related Publications (2)

• Wong J, Doherty HR, Singh M, Choi S, Siddiqui N, Lam D, Liyanage N, Tomlinson G, Chung F. The prevention of delirium in elderly surgical patients with obstructive sleep apnea (PODESA): a randomized controlled trial. BMC Anesthesiol. 2022 Sep 14;22(1):290. doi: 10.1186/s12871-022-01831-1.

  PMID: 36104664 DERIVED

• Wong J, Lam D, Choi S, Singh M, Siddiqui N, Sockalingam S, Chung F. The prevention of delirium in elderly with obstructive sleep apnea (PODESA) study: protocol for a multi-centre prospective randomized, controlled trial. BMC Anesthesiol. 2018 Jan 3;18(1):1. doi: 10.1186/s12871-017-0465-5.

  PMID: 29298664 DERIVED

MeSH Terms

Conditions

Sleep Apnea Syndromes; Delirium

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Jean Wong, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: September 23, 2016
• First Posted: November 3, 2016
• Study Start: March 24, 2016
• Primary Completion: April 30, 2021
• Study Completion: December 30, 2021
• Last Updated: November 2, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)