Effect of Lateral Versus Supine Positions on Postoperative Hypoxemia in Patients Undergoing Painless Gastroscopy and Colonoscopy: A Prospective Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 960
- 试验地点
- 1
- 主要终点
- Incidence of recovery-phase hypoxemia,
研究概览
简要总结
Using prospective real-world data, this study aims to determine whether the lateral decubitus position reduces the incidence of post-procedure hypoxemia in patients undergoing painless gastroscopy/colonoscopy, thereby providing a simple, non-invasive, and low-cost optimization strategy for clinical practice.
详细描述
Painless gastroscopy and colonoscopy have become essential modalities for the screening and diagnosis of digestive tract diseases, with their utilization increasing annually. However, hypoxemia remains the most common complication during these procedures, with reported incidences ranging widely from 1.8% to 69%. Severe hypoxemia can lead to adverse outcomes, including arrhythmias, hemodynamic decompensation, and hypoxic brain injury. Consequently, developing effective strategies to prevent hypoxemia in patients undergoing sedation for gastrointestinal (GI) endoscopy is of significant clinical value.
Current clinical research has primarily focused on hypoxemia occurring during the endoscopic procedure itself, whereas there is a paucity of high-quality evidence regarding the incidence and preventive measures of hypoxemia during the recovery phase. Specifically, the impact of body positioning on post-procedural hypoxemia remains largely unexplored. Emerging evidence suggests that the lateral decubitus position significantly reduces the incidence of hypoxemia during adult sedation. Anatomically, in the supine position, residual sedative effects combined with gravity cause the tongue and soft palate-structures lacking bony support-to collapse posteriorly, leading to upper airway obstruction. Conversely, the lateral position helps maintain a patent airway by preventing this collapse and optimizing the ventilation-perfusion (V/Q) matching, thereby stabilizing oxygenation.
Despite this theoretical basis, prospective studies investigating the effect of body positioning on recovery-phase hypoxemia in real-world settings are lacking. Therefore, this study hypothesizes that the lateral decubitus position reduces the incidence of recovery-phase hypoxemia compared to the supine position. Using prospective real-world data, we aim to validate this hypothesis and provide a simple, non-invasive, and cost-effective optimization strategy for 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
- Treatment
- 盲法
- Single (Participant)
盲法说明
Random sequence generation was performed by an independent statistician using computer-generated codes. Allocation concealment was maintained using sequentially numbered, opaque, sealed envelopes (SNOSE), which were opened immediately prior to intervention implementation. Due to the nature of the intervention (body positioning), blinding of participants and personnel was not feasible; however, outcome assessors were blinded, and objective outcome measures were utilized to minimize detection bias."
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
Supine position group (Group S)
The patient was turned from the predetermined left lateral position to the supine position without a head pillow (head-of-bed elevation at 0 degrees）
干预措施: Supine position group (Group S) (Procedure)
Lateral decubitus position group (Group L)
Upon arrival in the post-anesthesia care unit (PACU), the patient was kept in the left lateral decubitus position
干预措施: Lateral decubitus position group (Group L) (Procedure)
结局指标
主要结局
Incidence of recovery-phase hypoxemia,
时间窗: From PACU admission until discharge, assessed up to 30 minutes
Proportion of participants experiencing hypoxemia (SpO₂ ≤ 90% lasting \>10 seconds) during the post-procedure recovery period.
次要结局
- Incidence of Subclinical Respiratory Depression during Recovery(From PACU admission until discharge, assessed up to 30 minutes.)
- Incidence of Severe Hypoxemia During Recovery(From PACU admission until discharge, assessed up to 30 minutes)
- Overall Incidence of Airway Intervention During Recovery(From PACU admission until discharge, assessed up to 30 minutes)
- Cough Severity Grade During Recovery(From PACU admission until discharge, assessed up to 30 minutes)
- Length of Stay in Post-Anesthesia Care Unit (PACU)(From PACU admission until discharge)
- Respiratory Comfort Score During Recovery(From PACU admission until discharge, assessed up to 30 minutes)
- PACU Nurse Satisfaction Score(From PACU admission until discharge, assessed up to 30 minutes)
- Incidence of Tachycardia During Recovery(From PACU admission until discharge, assessed up to 30 minutes)
- Incidence of Bradycardia During Recovery(From PACU admission until discharge, assessed up to 30 minutes)
- Incidence of Hypotension During Recovery(From PACU admission until discharge, assessed up to 30 minutes)
- Incidence of Nausea or Vomiting During Recovery(From PACU admission until discharge, assessed up to 30 minutes)
- Incidence of Laryngospasm During Recovery(From PACU admission until discharge, assessed up to 30 minutes)