NCT05131009

Brief Summary

This study aims to collect perioperative diagnosis and treatment information of patients undergoing abdominal surgery at plateau and plain areas , collect blood and others samples for laboratory testing when necessary, analyzing the data to clarify the incidence and risk factors of pulmonary complications in patients undergoing abdominal surgery at different altitudes, so as to reduce the risk of pulmonary complications and even death in clinical practice.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

October 25, 2021

Completed
7 days until next milestone

Study Start

First participant enrolled

November 1, 2021

Completed
22 days until next milestone

First Posted

Study publicly available on registry

November 23, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

November 23, 2021

Status Verified

November 1, 2021

Enrollment Period

10 months

First QC Date

October 25, 2021

Last Update Submit

November 10, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • incidence and risk factors of pulmonary complications

    1 week after surgery

Secondary Outcomes (4)

  • ventilation duration,length of stay in ICU and Hospital Stay and death

    within the 30 days after surgery

  • incidence of Major Extrapulmonary Complications

    within the 30 days after surgery

  • Biomarkers

    1 week after surgery

  • incidence and risk factors of various specific pulmonary complications

    1 week after surgery

Study Arms (2)

Patients with pulmonary complications following abdominal surgery

Patients without pulmonary complications following abdominal surgery

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients aged 18 years or older who planned elective abdominal surgery under general anesthesia

You may qualify if:

  • ≥ 18 years old;
  • scheduled for elective abdominal surgery under general anesthesia;
  • ASAⅠ-Ⅲ

You may not qualify if:

  • Patients and their family members refused to be enrolled;
  • patients were unable to communicate because of language disorders such as dementia and hearing impairment;
  • patients were admitted to ICU 48 hours before operation;
  • preoperative diagnosis of ARDS, aspiration pneumonia, pulmonary embolism or pulmonary edema or other acute respiratory diseases;
  • mechanical ventilation within one week before operation;
  • death or discharge within 24 hours after operation;
  • second operation due to postoperative complications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China

Location

Central Study Contacts

Qingping Wu, Professor

CONTACT

Study Design

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

Study Record Dates

First Submitted

October 25, 2021

First Posted

November 23, 2021

Study Start

November 1, 2021

Primary Completion

September 1, 2022

Study Completion

September 1, 2022

Last Updated

November 23, 2021

Record last verified: 2021-11

Locations