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

October 31, 2022 updated by: Jean Wong, University Health Network, Toronto
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

220

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5T 2S8
        • Toronto Western Hospital
      • Toronto, Ontario, Canada
        • Mount Sinai Hospital
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CPAP therapy arm
Auto-titrating Continuous Positive Airway Pressure (CPAP)) treatment will be given on postoperative days 1, 2, and 3.
Other: CPAP treatment
Patients who are randomized to auto-titrating CPAP will use an auto CPAP device on postoperative days 1, 2, and 3
No Intervention: Control arm
no auto-titrating CPAP, standard care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative delirium
Time Frame: 2 MONTHS
The primary outcome is the incidence of postoperative delirium.
2 MONTHS

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of Hospital Stay
Time Frame: Depending on post operative recovery(2 days-2 months)
This parameter depends on post operative recovery
Depending on post operative recovery(2 days-2 months)
Time to ambulate
Time Frame: 1 week to 2 months
This parameter depending on lots of factors( eg; physiotherapy, weight, attitudes, other medical conditions ect...)
1 week to 2 months
Perioperative Complications
Time Frame: 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..)
10-14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Investigators

  • Principal Investigator: Jean Wong, MD, University Health Network, Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 24, 2016

Primary Completion (Actual)

April 30, 2021

Study Completion (Actual)

December 30, 2021

Study Registration Dates

First Submitted

September 23, 2016

First Submitted That Met QC Criteria

November 1, 2016

First Posted (Estimate)

November 3, 2016

Study Record Updates

Last Update Posted (Actual)

November 2, 2022

Last Update Submitted That Met QC Criteria

October 31, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-0122-B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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