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
연구 개요
상태
정황
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: xiaoyong wei, Master's degree
- 전화번호: 86-951-674-3252
- 이메일: weixy9912@126.com
연구 장소
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Ningxia
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Yinchuan, Ningxia, 중국, 750001
- 모병
- General hospital of Ningxia medical university, Yinchuan, Ningxia
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연락하다:
- xiaoyong wei
- 전화번호: 86-951-674-3252
- 이메일: weixy9912@126.cm
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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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실험적: 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.
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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°.
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실험적: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Incidence of recovery-phase hypoxemia
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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회복 중 기도 개입의 전체 발생률
기간: 회복실 입실부터 퇴실까지, 최대 30분 동안 평가
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회복 기간 동안 기도 개입(산소 흐름 증가, 턱 들기, 마스크 환기 또는 재삽관)이 필요한 참가자의 비율.
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회복실 입실부터 퇴실까지, 최대 30분 동안 평가
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회복 중 호흡 편안도 점수
기간: PACU 입원부터 퇴원까지, 최대 30분 동안 평가
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환자가 보고한 호흡 편안함은 0(가장 큰 불편함)에서 10(가장 큰 편안함)까지의 수치 평가 척도(NRS)를 사용하여 평가됨
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PACU 입원부터 퇴원까지, 최대 30분 동안 평가
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회복 기간 중 빈맥 발생률
기간: 회복실 입실 시부터 퇴실 시까지, 최대 30분 동안 평가됨
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시술 후 회복 기간 동안 빈맥(심박수 >100회/분)을 경험한 참가자의 비율.
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회복실 입실 시부터 퇴실 시까지, 최대 30분 동안 평가됨
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회복기 중 서맥 발생률
기간: 회복실 입실 시부터 퇴실까지, 최대 30분 동안 평가됨
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회복 기간 중 서맥(심박수 <50회/분)을 경험한 참가자의 비율
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회복실 입실 시부터 퇴실까지, 최대 30분 동안 평가됨
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회복 중 저혈압 발생률
기간: 회복실 입실부터 퇴실까지, 최대 30분 동안 평가
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회복 중 저혈압(수축기 혈압 <80 mmHg)을 경험한 참가자의 비율.
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회복실 입실부터 퇴실까지, 최대 30분 동안 평가
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회복기 동안의 메스꺼움 또는 구토 발생률
기간: PACU 입원부터 퇴원까지, 최대 30분 동안 평가됨
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회복 기간 중 오심(주관적 불편감) 또는 구토(위 내용물의 객관적 배출)를 경험한 참가자 비율.
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PACU 입원부터 퇴원까지, 최대 30분 동안 평가됨
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회복 중 후두경련 발생률
기간: 회복실 입실부터 퇴실까지, 최대 30분 동안 평가됨
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회복 중에 후두경련(스트라이더/환기가 불가능한 급성 상기도 폐쇄, 중재로 해결됨)을 경험한 참가자의 비율.
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회복실 입실부터 퇴실까지, 최대 30분 동안 평가됨
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Incidence of Subclinical Respiratory Depression during Recovery
기간: 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
기간: 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)
기간: 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
기간: 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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공동 작업자 및 조사자
협력자
수사관
- 연구 의자: Xinli Ni, Doctoral, 86-951-674-3252
연구 기록 날짜
연구 주요 날짜
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최초 제출
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