Obstructive Sleep Apnea in Elective Orthopaedic Surgery
Effects of Obstructive Sleep Apnea in Elective Orthopaedic Surgery
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.
調査の概要
研究の種類
段階
- 適用できない
連絡先と場所
研究場所
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Florida
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Miami、Florida、アメリカ、33136
- University of Miami Hospital
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:防止
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
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介入なし:Control
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.
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実験的:Intervention
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.
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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.
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Post Operative Complications both acute and short term
時間枠:90 days
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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.
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90 days
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Financial Impact
時間枠:90 days
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Readmission Rate
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90 days
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Financial Impact
時間枠:30 days
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Length of inpatient stay postoperatively
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30 days
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Financial Impact
時間枠:90 days
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Discharge location: Home versus skilled nursing facility versus inpatient rehabilitation versus long term care facility versus other
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90 days
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Functional Outcomes
時間枠:90 days
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Oxford Hip/Knee Score measured in units of the scale
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90 days
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Functional Outcomes
時間枠:90 days
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Western Ontario and McMaster Universities Arthritis Index measured in units of the scale, WOMAC
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90 days
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Functional Outcomes
時間枠:90 days
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Harris Hip/Knee Score measured in units of the scale
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90 days
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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
睡眠時無呼吸、閉塞性の臨床試験
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Fujian Shengdi Pharmaceutical Co., Ltd.募集
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University Hospital, Bonnわからない合併症 | 睡眠時無呼吸 (Apnea Hypopnea Index > 5/h として定義) | 頭蓋内動脈瘤のサイズ | 血圧の薬 | 合併症(くも膜下出血)ドイツ