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

Primary Purpose

Sleep Apnea

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
CPAP treatment
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sleep Apnea focused on measuring sleep apnea, delirium

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sunnybrook Hospital
  • Toronto Western Hospital
  • Mount Sinai Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

CPAP therapy arm

Control arm

Arm Description

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

no auto-titrating CPAP, standard care

Outcomes

Primary Outcome Measures

postoperative delirium
The primary outcome is the incidence of postoperative delirium.

Secondary Outcome Measures

Length of Hospital Stay
This parameter depends on post operative recovery
Time to ambulate
This parameter depending on lots of factors( eg; physiotherapy, weight, attitudes, other medical conditions ect...)
Perioperative Complications
Post operative complications include ICU admissions, hypoxia, re-intubation, Myocardial Infarctions, Wound Infections, Deep Vein Thrombosis, Pneumonia, Sepsis, Urinary Tract Infection, Stroke, etc..)

Full Information

First Posted
September 23, 2016
Last Updated
October 31, 2022
Sponsor
University Health Network, Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT02954224
Brief Title
Prevention Of Delirium in Elderly With Obstructive Sleep Apnea (PODESA)
Acronym
PODESA
Official Title
Prevention Of Delirium in Elderly With Obstructive Sleep Apnea (PODESA)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
March 24, 2016 (Actual)
Primary Completion Date
April 30, 2021 (Actual)
Study Completion Date
December 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Health Network, Toronto

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea
Keywords
sleep apnea, delirium

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
220 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CPAP therapy arm
Arm Type
Experimental
Arm Description
Auto-titrating Continuous Positive Airway Pressure (CPAP)) treatment will be given on postoperative days 1, 2, and 3.
Arm Title
Control arm
Arm Type
No Intervention
Arm Description
no auto-titrating CPAP, standard care
Intervention Type
Other
Intervention Name(s)
CPAP treatment
Intervention Description
Patients who are randomized to auto-titrating CPAP will use an auto CPAP device on postoperative days 1, 2, and 3
Primary Outcome Measure Information:
Title
postoperative delirium
Description
The primary outcome is the incidence of postoperative delirium.
Time Frame
2 MONTHS
Secondary Outcome Measure Information:
Title
Length of Hospital Stay
Description
This parameter depends on post operative recovery
Time Frame
Depending on post operative recovery(2 days-2 months)
Title
Time to ambulate
Description
This parameter depending on lots of factors( eg; physiotherapy, weight, attitudes, other medical conditions ect...)
Time Frame
1 week to 2 months
Title
Perioperative Complications
Description
Post operative complications include ICU admissions, hypoxia, re-intubation, Myocardial Infarctions, Wound Infections, Deep Vein Thrombosis, Pneumonia, Sepsis, Urinary Tract Infection, Stroke, etc..)
Time Frame
10-14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean Wong, MD
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sunnybrook Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Toronto Western Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
Facility Name
Mount Sinai Hospital
City
Toronto
State/Province
Ontario
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36104664
Citation
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.
Results Reference
derived
PubMed Identifier
29298664
Citation
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.
Results Reference
derived

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

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