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

NCT07587970 | Recruiting

• 1 other identifier: dywe0002
• Study Type: interventional
• Target: 1,617
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Hypoxemia

Outcome Measures

Primary Outcomes (1)

• Incidence of recovery-phase hypoxemia

  Proportion of participants experiencing hypoxemia (SpO₂ ≤ 90% lasting \>10 seconds) during the post-procedure recovery period

  From PACU admission until discharge, assessed up to 30 minutes

Secondary Outcomes (11)

• Incidence of Subclinical Respiratory Depression 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, assessed up to 30 minutes

• Respiratory Comfort Score During Recovery

  From PACU admission until discharge, assessed up to 30 minutes

Study Arms (3)

lateral decubitus head-up position group (LH group)

EXPERIMENTAL

The patient maintains the predetermined lateral position with the head of the bed elevated at 30 degrees.

Procedure: supine head-up position (SH group); Procedure: standard lateral decubitus position group (SL group)

supine head-up position group (SH group)

EXPERIMENTAL

The patient was transferred from a pre-existing lateral decubitus position to a supine position without a headrest, with the head of the bed elevated at 30 degrees.

Procedure: lateral decubitus head-up position (LH group); Procedure: standard lateral decubitus position group (SL group)

standard lateral decubitus position group (SL group)

EXPERIMENTAL

Patients should maintain their original left lateral position with the head of the bed elevated at 0 degrees.

Procedure: lateral decubitus head-up position (LH group); Procedure: supine head-up position (SH group)

Interventions

lateral decubitus head-up position (LH group) PROCEDURE

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°.

standard lateral decubitus position group (SL group); supine head-up position group (SH group)

supine head-up position (SH group) PROCEDURE

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°.

lateral decubitus head-up position group (LH group); standard lateral decubitus position group (SL group)

standard lateral decubitus position group (SL group) PROCEDURE

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°.

lateral decubitus head-up position group (LH group); supine head-up position group (SH group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• General Hospital of Ningxia Medical University: lead
• 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

Study Sites (1)

General hospital of Ningxia medical university, Yinchuan, Ningxia

Yinchuan, Ningxia, 750001, China

RECRUITING

Study Officials

• Xinli Ni, Doctoral

  86-951-674-3252

  STUDY CHAIR

Central Study Contacts

xiaoyong wei, Master's degree

CONTACT

86-951-674-3252; weixy9912@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: An independent statistician not involved in the study implementation generated random codes via computer. The allocation was concealed using sequentially numbered, opaque, sealed envelopes that were opened immediately before intervention implementation. Due to the nature of the intervention (postural factors), blinding was not feasible; instead, outcome evaluators were blinded. Data collection and statistical analysis of outcome indicators were performed by healthcare professionals independent of the study operations to minimize bias.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2026
• First Posted: May 14, 2026
• Study Start: May 12, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: May 14, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)