Effect of Different Body Positions on Hypoxemia During Recovery in Patients Undergoing Painless Gastroscopy and Colonoscopy
Effects of Lateral Decubitus Head-up Position, Supine Head-up Position, and Standard Lateral Decubitus Position on Hypoxemia During Recovery in Patients Undergoing Painless Gastroscopy and Colonoscopy: A Multicenter, Three-arm Randomized Controlled Trial
調査の概要
状態
条件
詳細な説明
Painless gastroscopy and colonoscopy have become the gold standard for screening and diagnosing gastrointestinal diseases due to their high patient comfort and excellent compliance rates, with their clinical application expanding annually. This procedure is performed under intravenous general anesthesia to achieve painlessness; however, anesthetic agents exert inhibitory effects on the patient's respiratory center. Additionally, the procedural manipulation causes irritation to the airways and gastrointestinal tract, leading to a high incidence of hypoxemia during the postoperative recovery phase-the most common respiratory adverse event associated with painless gastroscopy and colonoscopy. Mild cases may prolong patient recovery time, while severe cases can result in serious complications such as hypoxic brain injury or cardiac arrest, directly compromising patient safety and healthcare experience.
Positioning is a critical non-pharmacological intervention factor influencing perioperative respiratory function in patients undergoing painless gastroscopy and colonoscopy. Different positions alter thoracic compliance, airway patency, and diaphragmatic position, thereby affecting the patient's ventilation and oxygenation status. Currently, the standard lateral decubitus position is routinely used for painless gastroscopy and colonoscopy, and it has been demonstrated to reduce the incidence of hypoxemia. However, this position presents challenges such as difficulties in patient monitoring and localized pressure-related discomfort. In contrast, the supine head-up and lateral decubitus head-up positions, by elevating the head and adjusting the body angle, effectively mitigate tongue base prolapse and improve thoracic expansion, theoretically reducing the risk of hypoxemia. Nevertheless, there is currently a lack of multicenter, large-sample, prospective randomized controlled studies to compare the efficacy and safety of these three positions in preventing hypoxemia in recovery rooms for painless gastroscopy and colonoscopy patients. Consequently, there is no unified evidence-based guideline for selecting the optimal clinical positioning.
Based on this, this study focuses on three clinically common positions and employs a multicenter, three-arm, randomized controlled parallel design to systematically investigate the effects of lateral supine with head elevated, supine with head elevated, and standard lateral position on postoperative hypoxemia in patients undergoing painless gastroscopy and colonoscopy. The aim is to fill a research gap in this field and provide high-quality evidence-based medical data to optimize postoperative position management during recovery and reduce adverse respiratory events following painless gastrointestinal endoscopy.
Special Note：Prespecified subgroup analyses will be conducted based on age (<65 vs ≥65), sex, BMI, ASA class, smoking and alcohol use, Mallampati score, anesthetic agent (clobupol or propofol), type of endoscopy (gastroscopy, colonoscopy, or gastroenteroscopy), Ramsay sedation score (2-4), pre-procedure hypoxemia, prior pulmonary surgery, OSA, respiratory disease, and intra-procedural hypoxemia (SpO₂ ≤90% for >10 seconds). The influence of heterogeneity on the primary outcome will also be evaluated.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：xiaoyong wei, Master's degree
- 電話番号：86-951-674-3252
- メール：weixy9912@126.com
研究場所
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Ningxia
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Yinchuan、Ningxia、中国、750001
- 募集
- General hospital of Ningxia medical university, Yinchuan, Ningxia
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コンタクト：
- xiaoyong wei
- 電話番号：86-951-674-3252
- メール：weixy9912@126.cm
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-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Age ≥ 18 years.
- Both sexes.
- American Society of Anesthesiologists (ASA) physical status classification I-III.
- Scheduled for combined painless esophagogastroduodenoscopy/colonoscopy or either of the two procedures.
- Ability to understand the study protocol and provide written informed consent.
- A broad set of inclusion criteria was adopted to enroll a patient population that better reflects routine clinical practice. The study aimed to enhance the generalizability of the findings by including patients with various comorbidities, such as preprocedural hypoxemia (room-air SpO₂ ≤ 90%), history of pulmonary surgery, obstructive sleep apnea (OSA), and other pulmonary conditions (including asthma, COPD, chronic bronchitis, emphysema, and pulmonary bullae).
Exclusion Criteria:
- Severe cardiovascular or cerebrovascular diseases.
- Pregnant patients.
- History of hypersensitivity to ciprofol.
Withdrawal Criteria:
- Endotracheal intubation required during the procedure.
- Voluntary withdrawal requested by the patient or their legal representative.
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：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：lateral decubitus head-up position group (LH group)
The patient maintains the predetermined lateral position with the head of the bed elevated at 30 degrees.
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An angle measuring device is placed beside the head of the examination bed to facilitate precise adjustment of the head position.
Upon admission to the recovery room, the patient's Ramsay Sedation Scale score is assessed by an independent investigator (the attending anesthesiologist): 1 = agitated; 2 = fully awake, calm and cooperative; 3 = drowsy but responsive to verbal commands; 4 = drowsy but responsive to tactile or pain stimuli; 5 = asleep but slow to tactile or pain responses; 6 = deep sleep with no response.
Patients scoring 2-4 are immediately randomized into the study group, while those below this range are randomized after achieving the required score.
All patients are initially positioned in the left lateral decubitus position (head elevated at 0°, the same as during examination).
Patients assigned to the supine head-elevated group (SH group) are transitioned from the lateral position to supine without a headrest, with the head elevated at 30°.
An angle measuring device was placed beside the head of the examination bed to facilitate precise adjustment of the head position.
Upon admission to the recovery room, the patient's Ramsay Sedation Scale was assessed by an independent investigator (the attending anesthesiologist): 1 = agitated; 2 = fully awake, calm and cooperative; 3 = drowsy but responsive to verbal commands; 4 = drowsy but responsive to touch or pain; 5 = asleep but slow to respond to touch or pain; 6 = deep sleep with no response.
Patients scoring 2-4 were immediately randomized into the study group, while those below this range were randomized after achieving the required score.
All patients were initially positioned in the left lateral decubitus position (head elevated at 0°, the same as during examination).
Patients in the Standard Lateral Position Group (SL group) maintained their original left lateral position with the head elevated at 0°.
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|
実験的：supine head-up position group (SH group)
The patient was transferred from a pre-existing lateral decubitus position to a supine position without a headrest, with the head of the bed elevated at 30 degrees.
|
An angle measuring device was placed beside the head of the examination bed to facilitate precise adjustment of the head position.
Upon admission to the recovery room, the patient's Ramsay Sedation Scale was assessed by an independent investigator (the attending anesthesiologist): 1 = agitated; 2 = fully awake, calm and cooperative; 3 = drowsy but responsive to verbal commands; 4 = drowsy but responsive to touch or pain; 5 = asleep but slow to respond to touch or pain; 6 = deep sleep with no response.
Patients scoring 2-4 were immediately randomized into the study group, while those below this range were randomized after achieving the required score.
All patients were initially positioned in the left lateral decubitus position (head elevated at 0°, the same as during examination).
Patients in the Standard Lateral Position Group (SL group) maintained their original left lateral position with the head elevated at 0°.
An angle measuring device is placed beside the head of the examination bed to facilitate precise adjustment of the head position.
Upon admission to the recovery room, the patient's Ramsay Sedation Scale score is assessed by an independent investigator (the attending anesthesiologist): 1 = agitated; 2 = fully awake, calm and cooperative; 3 = drowsy but responsive to verbal commands; 4 = drowsy but responsive to touch or pain; 5 = asleep but slow to respond to touch or pain; 6 = deep sleep with no response.
Patients scoring 2-4 are immediately randomized into the study group, while those below this range are randomized after achieving the required score.
Prior to enrollment, all patients remain in the left lateral position (bed head elevated 0°, consistent with the examination position).
Patients assigned to the lateral supine head-elevated group (LH group) maintain their pre-assigned lateral position with the head elevated 30°.
|
|
実験的：standard lateral decubitus position group (SL group)
Patients should maintain their original left lateral position with the head of the bed elevated at 0 degrees.
|
An angle measuring device is placed beside the head of the examination bed to facilitate precise adjustment of the head position.
Upon admission to the recovery room, the patient's Ramsay Sedation Scale score is assessed by an independent investigator (the attending anesthesiologist): 1 = agitated; 2 = fully awake, calm and cooperative; 3 = drowsy but responsive to verbal commands; 4 = drowsy but responsive to tactile or pain stimuli; 5 = asleep but slow to tactile or pain responses; 6 = deep sleep with no response.
Patients scoring 2-4 are immediately randomized into the study group, while those below this range are randomized after achieving the required score.
All patients are initially positioned in the left lateral decubitus position (head elevated at 0°, the same as during examination).
Patients assigned to the supine head-elevated group (SH group) are transitioned from the lateral position to supine without a headrest, with the head elevated at 30°.
An angle measuring device is placed beside the head of the examination bed to facilitate precise adjustment of the head position.
Upon admission to the recovery room, the patient's Ramsay Sedation Scale score is assessed by an independent investigator (the attending anesthesiologist): 1 = agitated; 2 = fully awake, calm and cooperative; 3 = drowsy but responsive to verbal commands; 4 = drowsy but responsive to touch or pain; 5 = asleep but slow to respond to touch or pain; 6 = deep sleep with no response.
Patients scoring 2-4 are immediately randomized into the study group, while those below this range are randomized after achieving the required score.
Prior to enrollment, all patients remain in the left lateral position (bed head elevated 0°, consistent with the examination position).
Patients assigned to the lateral supine head-elevated group (LH group) maintain their pre-assigned lateral position with the head elevated 30°.
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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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Incidence of recovery-phase hypoxemia
時間枠：From PACU admission until discharge, assessed up to 30 minutes
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Proportion of participants experiencing hypoxemia (SpO₂ ≤ 90% lasting >10 seconds) during the post-procedure recovery period
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From PACU admission until discharge, assessed up to 30 minutes
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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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回復中の気道介入の全般的発生率
時間枠：PACU入室から退室まで、最大30分間評価
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回復期間中に気道処置（酸素流量の増加、顎挙上、マスク換気、または再挿管）を必要とした参加者の割合。
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PACU入室から退室まで、最大30分間評価
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回復時の呼吸快適度スコア
時間枠：PACU入室時から退室時まで、最大30分間評価
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患者報告による呼吸快適度を、0（最悪の不快感）から10（最大の快適感）までの数値評価尺度（NRS）を用いて評価
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PACU入室時から退室時まで、最大30分間評価
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回復中の頻脈発生率
時間枠：PACU入室時から退室時まで、最大30分間評価
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処置後の回復期間中に頻脈（心拍数>100回/分）を経験した参加者の割合。
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PACU入室時から退室時まで、最大30分間評価
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回復中の徐脈発生率
時間枠：PACU入室時から退室時まで、最大30分間評価
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回復期に徐脈（心拍数 <50拍／分）を経験した参加者の割合。
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PACU入室時から退室時まで、最大30分間評価
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回復中の低血圧の発症率
時間枠：PACU入室時から退室時まで、最大30分間評価
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回復期に低血圧（収縮期血圧 <80 mmHg）を経験した参加者の割合。
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PACU入室時から退室時まで、最大30分間評価
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回復期における吐き気または嘔吐の発生率
時間枠：PACU入室時から退室時まで、最大30分間評価
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回復期に悪心（主観的な訴え）または嘔吐（胃内容物の客観的排出）を経験した参加者の割合。
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PACU入室時から退室時まで、最大30分間評価
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回復中の喉頭痙攣の発生率
時間枠：PACU入室から退室まで、最大30分間評価
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回復期に喉頭痙攣（急性上気道閉塞、ストライダー／換気不能、介入により解消）を経験した参加者の割合。
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PACU入室から退室まで、最大30分間評価
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Incidence of Subclinical Respiratory Depression during Recovery
時間枠：From PACU admission until discharge, assessed up to 30 minutes.
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Proportion of participants experiencing subclinical respiratory depression, defined as any episode of pulse oxygen saturation (SpO₂) in the range of 90% to <95% (inclusive of 90%, exclusive of 95%) during the post-procedure recovery period
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From PACU admission until discharge, assessed up to 30 minutes.
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Cough Severity Grade During Recovery
時間枠：From PACU admission until discharge, assessed up to 30 minutes
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Severity of cough assessed during the recovery period, graded as: Grade I: No cough, smooth breathing; Grade II: Single mild cough; Grade III: Multiple coughs lasting <15 seconds; Grade IV: Continuous coughing lasting ≥15 seconds.
Reported as the proportion of participants reaching each grade (I-IV).
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From PACU admission until discharge, assessed up to 30 minutes
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Length of Stay in Post-Anesthesia Care Unit (PACU)
時間枠：From PACU admission until discharge, assessed up to 30 minutes
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Time from admission to the post-anesthesia care unit (PACU) until discharge criteria are met (modified Aldrete score ≥9 on three consecutive assessments), recorded in minutes.
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From PACU admission until discharge, assessed up to 30 minutes
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PACU Nurse Satisfaction Score
時間枠：From PACU admission until discharge, assessed up to 30 minutes
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Nurse-assessed satisfaction with patient respiratory stability and overall recovery management, rated using a Numerical Rating Scale (NRS) ranging from 0 (lowest satisfaction) to 10 (highest satisfaction), recorded at patient discharge from the post-anesthesia care unit
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From PACU admission until discharge, assessed up to 30 minutes
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協力者と研究者
協力者
捜査官
- スタディチェア：Xinli Ni, Doctoral、86-951-674-3252
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
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
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その他の研究ID番号
- dywe0002
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