Effect of Lateral Versus Supine Positions on Postoperative Hypoxemia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Lateral decubitus position group (Group L), Supine position group (Group S).
- Who it may be relevant to
- Registry conditions: Postoperative Hypoxemia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Lateral Versus Supine Positions on Postoperative Hypoxemia in Patients Undergoing Painless Gastroscopy and Colonoscopy: A Prospective Randomized Controlled Study
Overview
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.
Detailed description
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.
Interventions
- Procedure Lateral decubitus position group (Group L)
Upon admission to the Post-Anesthesia Care Unit (PACU), an independent researcher (attending anesthesiologist) assessed the patient using the Ramsay Sedation Scale (1: anxious and agitated; 2: awake, calm, and cooperative; 3: drowsy but responsive to verbal commands; 4: asleep but responsive to tactile stimulation or pain; 5: asleep with a sluggish response to stimulation; 6: deep sleep with no response). Patients in the Lateral Group (Group L) were maintained in the predetermined left lateral p - Procedure Supine position group (Group S)
Upon admission to the Post-Anesthesia Care Unit (PACU), an independent researcher (attending anesthesiologist) assessed the patient using the Ramsay Sedation Scale (1: anxious and agitated; 2: awake, calm, and cooperative; 3: drowsy but responsive to verbal commands; 4: asleep but responsive to tactile stimulation or pain; 5: asleep with a sluggish response to stimulation; 6: deep sleep with no response). Patients in the Supine Group (Group S) were turned from the predetermined lateral position
Primary outcome measures
- Incidence of recovery-phase hypoxemia, [Time frame: From PACU admission until discharge, assessed up to 30 minutes]
Secondary outcome measures (12)
- Incidence of Severe Hypoxemia During Recovery [Time frame: From PACU admission until discharge, assessed up to 30 minutes]
- Incidence of Subclinical Respiratory Depression during Recovery [Time frame: From PACU admission until discharge, assessed up to 30 minutes.]
- Overall Incidence of Airway Intervention During Recovery [Time frame: From PACU admission until discharge, assessed up to 30 minutes]
- Cough Severity Grade During Recovery [Time frame: From PACU admission until discharge, assessed up to 30 minutes]
- Length of Stay in Post-Anesthesia Care Unit (PACU) [Time frame: From PACU admission until discharge]
- Respiratory Comfort Score During Recovery [Time frame: From PACU admission until discharge, assessed up to 30 minutes]
- PACU Nurse Satisfaction Score [Time frame: From PACU admission until discharge, assessed up to 30 minutes]
- Incidence of Tachycardia During Recovery [Time frame: From PACU admission until discharge, assessed up to 30 minutes]
- Incidence of Bradycardia During Recovery [Time frame: From PACU admission until discharge, assessed up to 30 minutes]
- Incidence of Hypotension During Recovery [Time frame: From PACU admission until discharge, assessed up to 30 minutes]
- Incidence of Nausea or Vomiting During Recovery [Time frame: From PACU admission until discharge, assessed up to 30 minutes]
- Incidence of Laryngospasm During Recovery [Time frame: From PACU admission until discharge, assessed up to 30 minutes]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- General hospital of Ningxia medical university, Yinchuan, Ningxia — Yinchuan
Identifiers
NCT: NCT07545642 · dywe0001