General hospital of Ningxia medical university, Yinchuan, Ningxia
Yinchuan, Ningxia, 750001, China
Location status: Recruiting
NCT Number: NCT07545642
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.
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Request Info18 year and older
All sexes
Interventional
Not applicable
Yinchuan, Ningxia, 750001, China
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Withdrawal Criteria:
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 position. Standard monitoring was applied, and nasal cannula oxygen was administered at 2 L/min. If SpO₂ remained >95% for at least 5 minutes, oxygen was discontinued for observation. To ensure strict adherence to the protocol, an independent researcher continuously monitored and verified patient positioning (corrections were made only if the patient rolled unconsciously). Patients were evaluated using the Aldrete discharge scoring system; discharge from the PACU occurred when a score of >9 was a
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 to the supine position without a head pillow (head-of-bed elevation at 0 degrees). Standard monitoring was applied, and nasal cannula oxygen was administered at 2 L/min. If SpO₂ remained >95% for at least 5 minutes, oxygen was discontinued for observation. To ensure strict adherence to the protocol, an independent researcher continuously monitored and verified patient positioning (corrections were made only if the patient rolled unconsciously). Patients were evaluated using the Aldrete discharge
Time frame: 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.
Time frame: From PACU admission until discharge, assessed up to 30 minutes
Proportion of participants experiencing severe hypoxemia, defined as pulse oxygen saturation (SpO₂) < 85% lasting >10 seconds during the post-procedure recovery period.
Time frame: From PACU admission until discharge, assessed up to 30 minutes.
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.
Time frame: From PACU admission until discharge, assessed up to 30 minutes
Proportion of participants requiring any grade of airway intervention (increase oxygen flow, chin lift, mask ventilation, or reintubation) during recovery.
Time frame: From PACU admission until discharge, assessed up to 30 minutes
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).
Time frame: From PACU admission until discharge
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.
Time frame: From PACU admission until discharge, assessed up to 30 minutes
Patient-reported respiratory comfort assessed using a Numerical Rating Scale (NRS) ranging from 0 (worst discomfort) to 10 (greatest comfort)
Time frame: From PACU admission until discharge, assessed up to 30 minutes
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.
Time frame: From PACU admission until discharge, assessed up to 30 minutes
Proportion of participants experiencing tachycardia (heart rate >100 beats/min) during the post-procedure recovery period.
Time frame: From PACU admission until discharge, assessed up to 30 minutes
Proportion of participants experiencing bradycardia (heart rate <50 beats/min) during recovery.
Time frame: From PACU admission until discharge, assessed up to 30 minutes
Proportion of participants experiencing hypotension (systolic blood pressure <80 mmHg) during recovery.
Time frame: From PACU admission until discharge, assessed up to 30 minutes
Proportion of participants experiencing nausea (subjective complaint) or vomiting (objective expulsion of gastric contents) during recovery.
Time frame: From PACU admission until discharge, assessed up to 30 minutes
Proportion of participants experiencing laryngospasm (acute upper airway obstruction with stridor/inability to ventilate, resolving with intervention) during recovery.
Time frame: From PACU admission until discharge, assessed up to 30 minutes
Subgroup analyses will be conducted to explore heterogeneity of treatment effects on the primary outcome (incidence of recovery-phase hypoxemia) across baseline categories:
Demographics: age (<65 vs ≥65 years), sex, body mass index (BMI) category; Clinical characteristics: ASA physical status (I-II vs III), smoking/alcohol history, Mallampati classification (I-II vs III-IV); Procedural factors: endoscopy type (gastroscopy vs colonoscopy vs combined), preprocedural hypoxemia (room-air SpO₂ ≤90%), history of pulmonary surgery, obstructive sleep apnea (OSA), respiratory comorbidities (asthma/COPD/chronic bronchitis/emphysema/bullae), and intraprocedural hypoxemia (SpO₂ ≤90% >10 s); Postprocedural sedation: Ramsay Sedation Score (2-6). Effect modification will be tested using interaction terms in regression models (or stratified analysis with Cochran-Mantel-Haenszel test).
Contact information is provided by the study sponsor or research team.
General Hospital of Ningxia Medical University
Other
Effect of Lateral Versus Supine Positions on Postoperative Hypoxemia in Patients Undergoing Painless Gastroscopy and Colonoscopy: A Prospective Randomized Controlled Study
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