Effect of Preoxygenation Position and Examination Position on Hypoxemia During Painless Gastrointestinal Endoscopy
2026년 6월 24일 업데이트: General Hospital of Ningxia Medical University
Effect of Preoxygenation Position and Examination Position on Hypoxemia During Painless Gastrointestinal Endoscopy: A 2×2 Factorial Randomized Controlled Trial
To investigate the independent effects and interaction of pre-oxygenation position (left lateral vs left lateral with 30° head-up tilt) and examination position (left lateral vs left lateral with 30° head-up tilt) on hypoxemia during painless gastroscopy and colonoscopy using a 2×2 factorial design.
연구 개요
상태
아직 모집하지 않음
정황
상세 설명
Painless gastroscopy and colonoscopy represent core minimally invasive techniques for colorectal cancer screening and the diagnosis and treatment of gastrointestinal diseases. By utilizing intravenous sedation to ensure a pain-free experience, these procedures are widely adopted in clinical practice. However, perioperative hypoxemia remains the most common and critical safety complication during sedation for endoscopy. It is primarily caused by anesthesia-induced respiratory depression, tongue base collapse, airway obstruction, diaphragmatic compression, and restricted thoracic movement, with significantly elevated risks observed in obese, elderly, snoring, and short-necked patients.
Hypoxemia may trigger bradycardia, arrhythmias, myocardial ischemia, and cerebral hypoxia. In severe cases, it can lead to apnea, laryngospasm, and forced termination of the procedure, making it a key indicator in endoscopic anesthesia quality control.
Pre-oxygenation is a fundamental measure to increase functional residual capacity (FRC) and prolong the safe apneic time prior to induction, thereby preventing hypoxemia. The examination position directly determines airway patency, mandibular relaxation, diaphragmatic position, and thoracic compliance throughout the procedure. Both are critical, controllable factors regulating perioperative oxygenation. Studies have confirmed that the left lateral position reduces the incidence of hypoxemia, while the left lateral position with 30° head elevation effectively relaxes the mandible, alleviates tongue base collapse, reduces abdominal organ pressure on the diaphragm, and improves ventilation and oxygenation by increasing FRC.
Current research largely focuses on either the pre-oxygenation position or the examination position in isolation, presenting notable limitations: first, the interaction between these two positions has not been evaluated, leaving the synergistic or antagonistic effects of combined interventions unclear; second, there is a lack of efficient validation using a factorial design, which is necessary to simultaneously analyze the main effects and interactions of both independent variables.
Addressing these clinical challenges and research gaps, this study employs a 2×2 factorial randomized controlled design. With pre-oxygenation position and examination position serving as the two intervention factors, the study aims to explore the individual and combined effects of both factors on perioperative hypoxemia. The objective is to identify the optimal positional combination, establish standardized and generalizable positioning protocols for painless endoscopy, accurately reduce the incidence of hypoxemia, enhance the precision of anesthesia management, and provide high-level evidence to guide clinical practice.
연구 유형
중재적
등록 (추정된)
208
단계
- 해당 없음
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이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
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
- General Hospital of Ningxia Medical University
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연락하다:
- xiaoyong wei, Master's degree
- 전화번호: 86-951-674-3252
- 이메일: weixy9912@126.cm
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
- Aged 18 to 75 years, regardless of gender
- Body mass index (BMI): 18.5 - 35 kg/m²
- ASA physical status class I, II or III
- Scheduled for painless gastroscopy, painless colonoscopy, or combined painless gastroenteroscopy
- Able to understand the study procedure and provide written informed consent
Exclusion Criteria:
- Severe cardiopulmonary diseases, including severe COPD, heart failure, severe arrhythmia and pulmonary hypertension
- Difficult airway identified before anesthesia
- Severe obstructive sleep apnea (OSA)
- Spinal or thoracic deformity
- Preoperative baseline hypoxemia
- Known allergy to any anesthetic drugs used in this study
- Pregnant females
- Unable to cooperate with required intraoperative body position
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: Group A1B1 (traditional conventional group)
Pre-oxygenated left lateral position + examination in left lateral position
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An angle measuring device is placed beside the head of the examination bed to enable precise adjustment of the head position.
Pre-oxygenation phase: Administer pure oxygen via a standardized mask with tight fit, at a flow rate of 6 L/min; instruct the patient to take deep breaths while receiving continuous oxygen for 3 minutes, maintaining the same body position throughout.
If the position is altered during this phase, discontinue the procedure.
Left lateral pre-oxygenation: The patient assumes a left lateral position on a horizontal bed surface with the head elevated at 0°, supported by pillows to maintain a neutral spine position and avoid excessive neck extension or flexion.
다른 이름들:
Examination Phase: From the initiation of anesthesia and endoscope insertion until completion of the procedure, the patient's position and head-of-bed angle must remain fixed throughout; any adjustments are prohibited during this phase.
If the position is altered midway through the examination, the patient will be excluded from the study.
Left lateral position examination: The patient assumes a 90-degree left lateral position on a horizontal bed surface with the head of the bed elevated to 0°, supported by pillows to maintain a neutral spinal alignment, avoiding excessive neck extension or flexion.
다른 이름들:
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실험적: Group A1B2 (improved examination group)
Left lateral position with pre-oxygenation + left head elevated 30° during examination
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An angle measuring device is placed beside the head of the examination bed to enable precise adjustment of the head position.
Pre-oxygenation phase: Administer pure oxygen via a standardized mask with tight fit, at a flow rate of 6 L/min; instruct the patient to take deep breaths while receiving continuous oxygen for 3 minutes, maintaining the same body position throughout.
If the position is altered during this phase, discontinue the procedure.
Left lateral pre-oxygenation: The patient assumes a left lateral position on a horizontal bed surface with the head elevated at 0°, supported by pillows to maintain a neutral spine position and avoid excessive neck extension or flexion.
다른 이름들:
Examination Phase: From the initiation of anesthesia and endoscope insertion until completion of the procedure, the patient's position and head-of-bed angle must remain fixed throughout; any adjustments are prohibited during this phase.
If the position is altered midway through the examination, the patient will be excluded from the study.
Left lateral decubitus examination: The patient assumes a left lateral position on a horizontal bed surface with the head elevated at 30°, supported by a pillow to maintain a neutral spinal alignment, avoiding excessive neck extension or flexion.
다른 이름들:
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실험적: Group A2B1 (pre-oxygenation improvement group)
Left-sided head position at 30°, pre-oxygenated air administration + examination in left lateral decubitus position
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Examination Phase: From the initiation of anesthesia and endoscope insertion until completion of the procedure, the patient's position and head-of-bed angle must remain fixed throughout; any adjustments are prohibited during this phase.
If the position is altered midway through the examination, the patient will be excluded from the study.
Left lateral position examination: The patient assumes a 90-degree left lateral position on a horizontal bed surface with the head of the bed elevated to 0°, supported by pillows to maintain a neutral spinal alignment, avoiding excessive neck extension or flexion.
다른 이름들:
An angle measuring device is placed beside the head of the examination bed to allow precise adjustment of the head position.
Pre-oxygenation phase: The patient receives pure oxygen via a standardized mask with tight fit, at a flow rate of 6 L/min; they are instructed to take deep breaths while receiving continuous oxygen for 3 minutes, maintaining the same body position throughout.
If the position is altered during this phase, the procedure is discontinued.
Left-sided head elevation (30°): During pre-oxygenation, the patient lies in a left lateral position on a horizontal bed surface with the head elevated by 30°, supported by pillows to maintain a neutral spinal alignment and prevent excessive neck extension or flexion.
다른 이름들:
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실험적: Group A2B2 (double-position improvement group)
Left-sided head height at 30 weeks: pre-oxygenated condition + left-sided head height at 30 weeks examination
|
Examination Phase: From the initiation of anesthesia and endoscope insertion until completion of the procedure, the patient's position and head-of-bed angle must remain fixed throughout; any adjustments are prohibited during this phase.
If the position is altered midway through the examination, the patient will be excluded from the study.
Left lateral decubitus examination: The patient assumes a left lateral position on a horizontal bed surface with the head elevated at 30°, supported by a pillow to maintain a neutral spinal alignment, avoiding excessive neck extension or flexion.
다른 이름들:
An angle measuring device is placed beside the head of the examination bed to allow precise adjustment of the head position.
Pre-oxygenation phase: The patient receives pure oxygen via a standardized mask with tight fit, at a flow rate of 6 L/min; they are instructed to take deep breaths while receiving continuous oxygen for 3 minutes, maintaining the same body position throughout.
If the position is altered during this phase, the procedure is discontinued.
Left-sided head elevation (30°): During pre-oxygenation, the patient lies in a left lateral position on a horizontal bed surface with the head elevated by 30°, supported by pillows to maintain a neutral spinal alignment and prevent excessive neck extension or flexion.
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Incidence of hypoxemia
기간: During procedure
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Incidence of SpO₂ ≤ 90% for >10 seconds during the examination.
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During procedure
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Safe duration of pre-oxygenation
기간: During procedure
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Time from cessation of oxygen administration (start of anesthesia induction) to first SpO₂ <92% for ≥3 seconds.
If no desaturation occurs, the value equals the duration from oxygen cessation to end of procedure (right-censored).
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During procedure
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Incidence of subclinical respiratory depression
기간: During procedure
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Defined as the proportion of participants experiencing SpO₂ between 90% and 95% (inclusive) at any time during the examination.
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During procedure
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Requirement for jaw thrust
기간: During procedure
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Number of participants requiring manual jaw thrust to relieve airway obstruction during the examination.
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During procedure
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Requirement for nasal cannula oxygen
기간: During procedure
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Number of participants requiring oxygen supplementation via nasal cannula during the examination.
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During procedure
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Requirement for increased oxygen flow
기간: During procedure
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Number of participants requiring an increase in oxygen flow rate during the examination.
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During procedure
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Requirement for mask ventilation
기간: During procedure
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Number of participants requiring bag-mask ventilation during the examination.
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During procedure
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Requirement for endotracheal intubation
기간: During procedure
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Number of participants requiring endotracheal intubation during the examination.
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During procedure
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Incidence of airway intervention
기간: During procedure
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Proportion of participants requiring any airway intervention (jaw thrust, nasal cannula, increased flow, mask ventilation, or intubation)
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During procedure
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Severity of coughing
기간: During procedure
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Assessed using a 4-grade scale: Grade I (none), Grade II (single mild episode), Grade III (multiple episodes <15s), Grade IV (continuous >15s)
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During procedure
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Length of stay in recovery room
기간: Up to 30 minutes post-anesthesia care unit (PACU) admission
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Time from arrival to discharge from the recovery room (maximum observation 30 minutes)
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Up to 30 minutes post-anesthesia care unit (PACU) admission
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Endoscopist satisfaction score
기간: During procedure
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Assessed using a Numerical Rating Scale (NRS) ranging from 0 to 10, with higher scores indicating greater satisfaction.
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During procedure
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Incidence of postoperative nausea, vomiting, headache, and dizziness
기간: Up to 30 minutes post-anesthesia care unit (PACU) admission
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Proportion of participants experiencing nausea, vomiting, headache, or dizziness after awakening in the recovery room.
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Up to 30 minutes post-anesthesia care unit (PACU) admission
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Safety outcome endpoints：heart rate
기간: Baseline and during procedure
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Recorded at T0 (before pre-oxygenation), T1 (before induction), T2 (scope insertion), and T3 (scope removal).
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Baseline and during procedure
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Safety outcome endpoints：blood pressure
기간: Baseline and during procedure
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Recorded at T0 (before pre-oxygenation), T1 (before induction), T2 (scope insertion), and T3 (scope removal)
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Baseline and during procedure
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Safety outcome endpoints：peripheral oxygen saturation (SpO₂)
기간: Baseline and during procedure
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Recorded at T0 (before pre-oxygenation), T1 (before induction), T2 (scope insertion), and T3 (scope removal).
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Baseline and during procedure
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Safety outcome endpoints：Incidence of hemodynamic instability in recovery
기간: Up to 30 minutes post-anesthesia care unit (PACU) admission
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Occurrence of tachycardia (>100 bpm), bradycardia (<50 bpm), or hypotension (systolic blood pressure <80 mmHg) during the recovery period.
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Up to 30 minutes post-anesthesia care unit (PACU) admission
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여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 연구 의자: Xinli Ni, Doctoral, General Hospital of Ningxia Medical University
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 6월 23일
기본 완료 (추정된)
2026년 7월 31일
연구 완료 (추정된)
2026년 8월 31일
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처음 게시됨 (실제)
2026년 6월 29일
연구 기록 업데이트
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