Effect of Preoxygenation Position and Examination Position on Hypoxemia During Painless Gastrointestinal Endoscopy: A 2×2 Factorial Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 208
- 试验地点
- 1
- 主要终点
- Incidence of hypoxemia
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
Independent statisticians not involved in the study implementation generated random codes via computer and used sequentially numbered, opaque, sealed envelopes to conceal assignment assignments, which were opened immediately prior to intervention administration. Since postural intervention is an operational procedure, blinding could not be implemented for operators (anesthesiologists, endoscopists, or data collectors); subjects were informed of the standard positioning requirements. Data analysts remained completely blinded throughout the process, unaware of patient group assignments, thereby minimizing bias.
入排标准
- 年龄范围
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Group A1B1 (traditional conventional group)
Pre-oxygenated left lateral position + examination in left lateral position
干预措施: Pre-oxygenation Position (left lateral position) (Procedure)
Group A1B1 (traditional conventional group)
Pre-oxygenated left lateral position + examination in left lateral position
干预措施: Examination Position(left lateral position ) (Procedure)
Group A1B2 (improved examination group)
Left lateral position with pre-oxygenation + left head elevated 30° during examination
干预措施: Pre-oxygenation Position (left lateral position) (Procedure)
Group A2B1 (pre-oxygenation improvement group)
Left-sided head position at 30°, pre-oxygenated air administration + examination in left lateral decubitus position
干预措施: Examination Position(left lateral position ) (Procedure)
Group A1B2 (improved examination group)
Left lateral position with pre-oxygenation + left head elevated 30° during examination
干预措施: Examination Position(left lateral head elevation in a 30-degree position) (Procedure)
Group A2B1 (pre-oxygenation improvement group)
Left-sided head position at 30°, pre-oxygenated air administration + examination in left lateral decubitus position
干预措施: Pre-oxygenation Position( left lateral head elevation in a 30-degree position) (Procedure)
Group A2B2 (double-position improvement group)
Left-sided head height at 30 weeks: pre-oxygenated condition + left-sided head height at 30 weeks examination
干预措施: Pre-oxygenation Position( left lateral head elevation in a 30-degree position) (Procedure)
Group A2B2 (double-position improvement group)
Left-sided head height at 30 weeks: pre-oxygenated condition + left-sided head height at 30 weeks examination
干预措施: Examination Position(left lateral head elevation in a 30-degree position) (Procedure)
结局指标
主要结局
Incidence of hypoxemia
时间窗: During procedure
Incidence of SpO₂ ≤ 90% for \>10 seconds during the examination.
次要结局
- Requirement for increased oxygen flow(During procedure)
- Requirement for mask ventilation(During procedure)
- Requirement for endotracheal intubation(During procedure)
- Incidence of airway intervention(During procedure)
- Severity of coughing(During procedure)
- Length of stay in recovery room(Up to 30 minutes post-anesthesia care unit (PACU) admission)
- Endoscopist satisfaction score(During procedure)
- Incidence of postoperative nausea, vomiting, headache, and dizziness(Up to 30 minutes post-anesthesia care unit (PACU) admission)
- Requirement for nasal cannula oxygen(During procedure)
- Safe duration of pre-oxygenation(During procedure)
- Incidence of subclinical respiratory depression(During procedure)
- Requirement for jaw thrust(During procedure)
