Obstructive Sleep Apnea in Elective Orthopaedic Surgery

Sleep Apnea, Obstructive Clinical Trial

Official title:

Effects of Obstructive Sleep Apnea in Elective Orthopaedic Surgery

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03166462
• Other study ID #: 20160732
• Status: Withdrawn
• Phase: N/A
• First received: September 7, 2016
• Last updated: March 8, 2018
• Start date: February 8, 2018
• Est. completion date: February 8, 2018

Study information

• Verified date: March 2018
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 8, 2018
• Est. primary completion date: February 8, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• Evaluation 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.

Locations

Country	Name	City	State
United States	University of Miami Hospital	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	90 days
Secondary	Financial Impact	Readmission Rate	90 days
Secondary	Financial Impact	Length of inpatient stay postoperatively	30 days
Secondary	Financial Impact	Discharge location: Home versus skilled nursing facility versus inpatient rehabilitation versus long term care facility versus other	90 days
Secondary	Functional Outcomes	Oxford Hip/Knee Score measured in units of the scale	90 days
Secondary	Functional Outcomes	Western Ontario and McMaster Universities Arthritis Index measured in units of the scale, WOMAC	90 days
Secondary	Functional Outcomes	Harris Hip/Knee Score measured in units of the scale	90 days