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Obstructive Sleep Apnea in Elective Orthopaedic Surgery

Primary Purpose

Sleep Apnea, Obstructive, Total Knee Arthroplasty, Total Hip Arthroplasty

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Evaluation by Sleep Medicine Specialists
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sleep Apnea, Obstructive

Eligibility Criteria

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

Inclusion Criteria:

  • > 18 years of age
  • Have signed the written informed consent form
  • STOP-BANG score greater than or equal to 5

Exclusion Criteria:

  • Patients not fluent in the language of the informed consent form (English, Spanish, Creole)
  • Prisoners
  • Pregnancy
  • Reported to have mental illness or belonging to a vulnerable population
  • Patients with previous diagnosis and treatment of Obstructive sleep apnea

Sites / Locations

  • University of Miami Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Intervention

Arm Description

Patients in this arm will proceed through the current standard of care for pre-operative screening performed by either the patient's primary care physician or the "pre-operative" anesthesia clinic which screens patients prior to total knee or total hip arthroplasty.

Patients in this arm will be referred to the Sleep Medicine clinic at the University of Miami Hospital for additional testing and evaluation for obstructive sleep apnea. If they are successfully diagnosed, they will receive appropriate treatment and any interventions for the peri-operative period as recommended by the pulmonary medicine team.

Outcomes

Primary Outcome Measures

Post Operative Complications both acute and short term
The investigators will assess if screening and subsequent treatment for obstructive sleep apnea reduces the incidence of unplanned admission to the intensive care unit, post operative delirium, post operative hypoxia necessitating supplemental oxygen, myocardial infarction as measured by objective measures such as troponin levels and EKG changes and thromboembolism. The incidence of any one of these factors is relatively low. Therefore the investigators will aggregate them as the number of subjects needed to asses them individually would be too large.

Secondary Outcome Measures

Financial Impact
Readmission Rate
Financial Impact
Length of inpatient stay postoperatively
Financial Impact
Discharge location: Home versus skilled nursing facility versus inpatient rehabilitation versus long term care facility versus other
Functional Outcomes
Oxford Hip/Knee Score measured in units of the scale
Functional Outcomes
Western Ontario and McMaster Universities Arthritis Index measured in units of the scale, WOMAC
Functional Outcomes
Harris Hip/Knee Score measured in units of the scale

Full Information

First Posted
September 7, 2016
Last Updated
March 8, 2018
Sponsor
University of Miami
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1. Study Identification

Unique Protocol Identification Number
NCT03166462
Brief Title
Obstructive Sleep Apnea in Elective Orthopaedic Surgery
Official Title
Effects of Obstructive Sleep Apnea in Elective Orthopaedic Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Lack of funding and clinical resources
Study Start Date
February 8, 2018 (Actual)
Primary Completion Date
February 8, 2018 (Anticipated)
Study Completion Date
February 8, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Demand for Total Knee Arthroplasty (TKA) and Total Hip Arthroplasty (THA) is increasing steadily and is projected to continue trending upwards in the coming years. Concomitant with that trend is the increase in prevalence of obesity. Obesity serves as a common risk factor for osteoarthritis, obstructive sleep apnea and medical complications. Obstructive Sleep Apnea (OSA) is defined as episodes of obstructive apneas and hypopneas during sleep, with daytime somnolence. It occurs commonly in obese, middle age and elderly men and has an estimated prevalence of 5% - 9%. Pre-operative screening for elective surgical procedures is a critical component of a successful surgical outcome. Patients with medical comorbidities ideally will undergo medical treatment or optimization to minimize the risk peri-operatively and post-operatively. Obstructive sleep apnea has been shown in numerous studies to be a risk factor for cardiopulmonary complications following surgery. The contributing factors include alterations in REM sleep post-operatively and opioid induced respiratory suppression post-operatively. The STOP-BANG patient questionnaire is a validated patient survey that uses both objective and subjective data to screen patients for their risk of OSA. The sensitivity of the STOP-BANG questionnaire for moderate-to-severe OSA has been estimated as high as 97.74%. Authors have also shown that higher STOP-BANG scores are independently associated with increased risk for post-operative complication. Other authors have utilized similar pre-operative questionnaires to screen for occult pulmonary disease in patients scheduled for elective joint arthroplasty. They found a slightly increased incidence of OSA in this population as compared with the national average, over 50% of which were previously undiagnosed. The American Society of Anesthesiologists task force on perioperative management of patients with OSA published extensive guidelines aimed at reducing morbidity and mortality. Improved diagnosis pre-operatively could aid in proper compliance with these guidelines. These recommendations include preferential use of regional analgesia, reduction in systemic opioids, monitoring of oxygen saturation and nonsupine posture. The mainstay of treatment for OSA is a positive pressure airway device such as Continuous Positive Airway Pressure (CPAP) or in severe cases Nasal Intermittent Positive Pressure Ventilation (NIPPV). Post-operatively continuation of these treatments in patients with known OSA is often recommended. Some authors have demonstrated reductions in Apnea-Hypopnea Index postoperatively through the use of CPAP. However, a recent meta-analysis evaluating the effect of pre-operative or post-operative CPAP in patients with OSA concluded that the use of CPAP did not reduce post-operative adverse events. Given the projected increase in demand for joint arthroplasty, the ever-increasing incidence of obesity, the ambiguity surrounding the topic and the potential to clinically impact post-operative morbidity, mortality and health care costs, shows the need for further studies.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, Obstructive, Total Knee Arthroplasty, Total Hip Arthroplasty

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients in this arm will proceed through the current standard of care for pre-operative screening performed by either the patient's primary care physician or the "pre-operative" anesthesia clinic which screens patients prior to total knee or total hip arthroplasty.
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Patients in this arm will be referred to the Sleep Medicine clinic at the University of Miami Hospital for additional testing and evaluation for obstructive sleep apnea. If they are successfully diagnosed, they will receive appropriate treatment and any interventions for the peri-operative period as recommended by the pulmonary medicine team.
Intervention Type
Other
Intervention Name(s)
Evaluation by Sleep Medicine Specialists
Intervention Description
Patients randomized to the intervention arm will be referred to the sleep medicine specialists for evaluation. All of their recommendations will be followed if indicated.
Primary Outcome Measure Information:
Title
Post Operative Complications both acute and short term
Description
The investigators will assess if screening and subsequent treatment for obstructive sleep apnea reduces the incidence of unplanned admission to the intensive care unit, post operative delirium, post operative hypoxia necessitating supplemental oxygen, myocardial infarction as measured by objective measures such as troponin levels and EKG changes and thromboembolism. The incidence of any one of these factors is relatively low. Therefore the investigators will aggregate them as the number of subjects needed to asses them individually would be too large.
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Financial Impact
Description
Readmission Rate
Time Frame
90 days
Title
Financial Impact
Description
Length of inpatient stay postoperatively
Time Frame
30 days
Title
Financial Impact
Description
Discharge location: Home versus skilled nursing facility versus inpatient rehabilitation versus long term care facility versus other
Time Frame
90 days
Title
Functional Outcomes
Description
Oxford Hip/Knee Score measured in units of the scale
Time Frame
90 days
Title
Functional Outcomes
Description
Western Ontario and McMaster Universities Arthritis Index measured in units of the scale, WOMAC
Time Frame
90 days
Title
Functional Outcomes
Description
Harris Hip/Knee Score measured in units of the scale
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: > 18 years of age Have signed the written informed consent form STOP-BANG score greater than or equal to 5 Exclusion Criteria: Patients not fluent in the language of the informed consent form (English, Spanish, Creole) Prisoners Pregnancy Reported to have mental illness or belonging to a vulnerable population Patients with previous diagnosis and treatment of Obstructive sleep apnea
Facility Information:
Facility Name
University of Miami Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Obstructive Sleep Apnea in Elective Orthopaedic Surgery

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