Effect of Different Body Positions on Hypoxemia During Recovery in Patients Undergoing Painless Gastroscopy and Colonoscopy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGeneral Hospital of Ningxia Medical University

About this trial

Through a multicenter, three-arm randomized controlled trial design, this study aimed to compare the effects of three positioning strategies-side-lying with elevated head position, supine with elevated head position, and standard side-lying position-on the incidence of hypoxemia during the recovery phase in patients undergoing painless gastroscopy and colonoscopy. The goal was to provide clinicians with a simple, non-invasive, and cost-effective optimization strategy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Severe cardiovascular or cerebrovascular diseases.

Pregnant patients.

History of hypersensitivity to ciprofol.

Endotracheal intubation required during the procedure.

Trial design

Design model

Parallel

Treatments tested in this trial

  • lateral decubitus head-up position (LH group)

    Procedure/Surgery

    An angle measuring device is placed beside the head of the examination bed to facilitate precise adjustment of the head position. Upon admission to the recovery room, the patient's Ramsay Sedation Scale score is assessed by an independent investigator (the attending anesthesiologist): 1 = agitated; 2 = fully awake, calm and cooperative; 3 = drowsy but responsive to verbal commands; 4 = drowsy but responsive to touch or pain; 5 = asleep but slow to respond to touch or pain; 6 = deep sleep with no response. Patients scoring 2-4 are immediately randomized into the study group, while those below this range are randomized after achieving the required score. Prior to enrollment, all patients remain in the left lateral position (bed head elevated 0°, consistent with the examination position). Patients assigned to the lateral supine head-elevated group (LH group) maintain their pre-assigned lateral position with the head elevated 30°.

  • supine head-up position (SH group)

    Procedure/Surgery

    An angle measuring device is placed beside the head of the examination bed to facilitate precise adjustment of the head position. Upon admission to the recovery room, the patient's Ramsay Sedation Scale score is assessed by an independent investigator (the attending anesthesiologist): 1 = agitated; 2 = fully awake, calm and cooperative; 3 = drowsy but responsive to verbal commands; 4 = drowsy but responsive to tactile or pain stimuli; 5 = asleep but slow to tactile or pain responses; 6 = deep sleep with no response. Patients scoring 2-4 are immediately randomized into the study group, while those below this range are randomized after achieving the required score. All patients are initially positioned in the left lateral decubitus position (head elevated at 0°, the same as during examination). Patients assigned to the supine head-elevated group (SH group) are transitioned from the lateral position to supine without a headrest, with the head elevated at 30°.

  • standard lateral decubitus position group (SL group)

    Procedure/Surgery

    An angle measuring device was placed beside the head of the examination bed to facilitate precise adjustment of the head position. Upon admission to the recovery room, the patient's Ramsay Sedation Scale was assessed by an independent investigator (the attending anesthesiologist): 1 = agitated; 2 = fully awake, calm and cooperative; 3 = drowsy but responsive to verbal commands; 4 = drowsy but responsive to touch or pain; 5 = asleep but slow to respond to touch or pain; 6 = deep sleep with no response. Patients scoring 2-4 were immediately randomized into the study group, while those below this range were randomized after achieving the required score. All patients were initially positioned in the left lateral decubitus position (head elevated at 0°, the same as during examination). Patients in the Standard Lateral Position Group (SL group) maintained their original left lateral position with the head elevated at 0°.

Treatment groups

1,617 Participants
are divided into 3 treatment groups
Group A: lateral decubitus head-up position group (LH group)Experimental treatment 2 interventions
Group B: supine head-up position group (SH group)Experimental treatment 2 interventions
Group C: standard lateral decubitus position group (SL group)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Incidence of recovery-phase hypoxemia

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

Secondary outcomes

1

Incidence of Subclinical Respiratory Depression during Recovery

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.
2

Overall Incidence of Airway Intervention During Recovery

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
3

Cough Severity Grade During Recovery

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, assessed up to 30 minutes
4

Length of Stay in Post-Anesthesia Care Unit (PACU)

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

General Hospital of Ningxia Medical University

Lead sponsor

Yinchuan Traditional Chinese Medicine Hospital

Collaborator

Guyuan Municipal People's Hospital

Collaborator

Wuzhong City People's Hospital

Collaborator

Zhongwei City People's Hospital

Collaborator

Shizuishan City People's Hospital

Collaborator

Zhongwei City Traditional Chinese Medicine Hospital

Collaborator

Pingluo County People's Hospital

Collaborator

Tongxin County People's Hospital

Collaborator

Yanchi County People's Hospital

Collaborator

Zhongning County People's Hospital

Collaborator

Lingwu City People's Hospital

Collaborator

Qingtongxia City People's Hospital

Collaborator