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Obstructive Sleep Apnea in Elective Orthopaedic Surgery

Effects of Obstructive Sleep Apnea in Elective Orthopaedic Surgery

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03166462
Enrollment
0
Registered
2017-05-25
Start date
2018-02-08
Completion date
2018-02-08
Last updated
2018-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

OTHEREvaluation by Sleep Medicine Specialists

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.

Sponsors

University of Miami
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Post Operative Complications both acute and short term90 daysThe 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

MeasureTime frameDescription
Financial Impact90 daysReadmission Rate
Functional Outcomes90 daysOxford Hip/Knee Score measured in units of the scale

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026