NCT07362706

Brief Summary

This study aims to investigate the effect of prolonged tracheal intubation removal on the incidenceof postoperative complications in patients with gastric cancer complicated with severe obstructive sleepapnea.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
240

participants targeted

Target at P75+ for all trials

Timeline
25mo left

Started Jan 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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 Progress63%
Jan 2023Jun 2028

Study Start

First participant enrolled

January 1, 2023

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

August 27, 2025

Completed
5 months until next milestone

First Posted

Study publicly available on registry

January 23, 2026

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2026

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2028

Expected
Last Updated

January 23, 2026

Status Verified

March 1, 2025

Enrollment Period

3.1 years

First QC Date

August 27, 2025

Last Update Submit

January 15, 2026

Conditions

Keywords

Radical gastrectomySevere obstructive sleep apnea

Outcome Measures

Primary Outcomes (1)

  • Postoperative complications

    The incidence of postoperative complications in patients with gastric cancer complicated with severe obstructive sleepapnea.

    48-72 hour

Interventions

The patients were divided into two groups, the extended tracheal intubationremoval time group (24-48h)and the non-extended tracheal intubation removal time group, and the incidenceof surgery-related complications and non-surgical-related complications in the two groups werecompared.

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with gastric cancer complicated with severe sleep apnea

You may qualify if:

  • Patients preoperatively diagnosed with resectable gastric cancer
  • Patients without distant organ metastasis
  • Patients with preoperative Overnight Cardiorespiratory Sleep Testing (OCST) or Polysomnography (PSG) results showing Apnea-Hypopnea Index (AHI) \>30 events/hour and SaO₂ \<80%
  • Patients with cardiopulmonary function deemed suitable for surgery
  • Patients aged 18-85 years
  • Patients who voluntarily joined this study and provided written informed consent

You may not qualify if:

  • Patients with a history of or concurrent other malignant tumors
  • Patients who underwent palliative resection
  • Subjects who experienced acute cardiovascular or cerebrovascular events (e.g., acute cerebral infarction, acute coronary syndrome) within the past 3 months, or whose cardiovascular clinical symptoms/diseases are not well-controlled
  • Patients with a history of psychotropic drug abuse that cannot be abstained, or those with psychiatric disorders
  • Patients with concomitant diseases that, in the investigator's judgment, seriously endanger the patient's safety or affect the completion of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, 250000, China

Location

MeSH Terms

Conditions

Sleep Apnea, ObstructiveStomach Neoplasms

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 27, 2025

First Posted

January 23, 2026

Study Start

January 1, 2023

Primary Completion

February 10, 2026

Study Completion (Estimated)

June 30, 2028

Last Updated

January 23, 2026

Record last verified: 2025-03

Locations