NCT07594951

Brief Summary

Abstract: Objective: This study aimed to investigate the effect of different bed angles (0° vs. 15°) on the incidence of intraoperative hypoxemia in patients undergoing gastroscopy and colonoscopy. A prospective randomized controlled trial was conducted to evaluate the impact of patient positioning on respiratory safety, providing evidence for individualized anesthesia management. Background: With the increasing popularity of painless gastrointestinal endoscopy, hypoxemia has become a major safety concern in anesthesia management, particularly in elderly and obese patients. Studies have shown that the incidence of hypoxemia can exceed 26%, highlighting the importance of optimizing respiratory safety during anesthesia. Methods: A total of 400 patients scheduled for painless gastrointestinal endoscopy were recruited and randomly assigned to a control group (0° left lateral position) or an experimental group (15° left lateral position). Baseline data were recorded preoperatively. Intraoperative vital signs were monitored, and the occurrence of hypoxemia and other complications was documented. Data were collected and processed in a blinded manner, followed by statistical analysis using SPSS 26.0.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
1mo left

Started May 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress36%
May 2026Jul 2026

Study Start

First participant enrolled

May 1, 2026

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

May 11, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 19, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

May 19, 2026

Status Verified

March 1, 2026

Enrollment Period

2 months

First QC Date

May 11, 2026

Last Update Submit

May 18, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Hypoxemia

    Hypoxemia (75% \< SpO₂ \< 90% lasting \> 10 seconds and \< 60 seconds)

    During the procedure

Study Arms (2)

Group 15°

OTHER

Elevating the head of the bed to 15 degrees

Other: Elevating the head of the bed to 15 degrees

Group 0°

NO INTERVENTION

Interventions

Elevating the head of the bed to 15 degrees

Group 15°

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years
  • Planned to undergo painless (sedated) gastrointestinal endoscopy
  • Signed informed consent form
  • American Society of Anesthesiologists (ASA) Physical Status classification I to III

You may not qualify if:

  • Pregnancy
  • Emergency examination or inadequate bowel preparation
  • Baseline peripheral oxygen saturation (SpO₂) \< 95%
  • Patient or family members refuse to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

XuZiHang ZiHangXu

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2026

First Posted

May 19, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

May 19, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

We currently have no plan to share individual participant data (IPD). The data belong to the institution as proprietary resources and are exclusively reserved for internal use. Access to the data can only be considered under specific institutional agreements and with proper authorization.