- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06277518
System for Postoperative Admission to ICU for Patients With Digestive System Malignancy
February 19, 2024 updated by: General Hospital of Ningxia Medical University
Establishment and Application of Decision System for Postoperative Admission to ICU for Patients With Digestive System Malignancy
Postoperative admission to ICU for patients with digestive system tumors is one of the most common postoperative complications of all non-cardiac surgeries.
The study found that supportive treatment of critically ill patients admitted to ICU after surgery was conducive to reducing mortality, and the most common complications of postoperative ICU admission were infections, especially respiratory infections and surgical site infections.
A growing body of evidence supports that ICU stays are expensive, always occupy major hospital resources, and are associated with the worst outcomes.
To date, there is insufficient evidence to determine which patients with digestive system tumors benefit the most from being admitted to the ICU after surgery.
Therefore, this study intends to adopt retrospective study to determine the risk factors of postoperative ICU transfer for patients with digestive system malignant tumor, and build a risk prediction model for postoperative ICU admission, so as to guide the decision of postoperative ICU transfer for patients with digestive system malignant tumor.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
The incidence of malignant tumors of digestive system is increasing year by year in the world, and surgical treatment is the first choice for malignant tumors of digestive system.
Most of these patients were elderly, had more complications before surgery, had greater surgical trauma, and had a high proportion of postoperative ICU admission.
In recent three years, 28.1% of patients with malignant tumor of digestive system were admitted to ICU after surgery.
The study found that postoperative ICU care in critically ill patients was conducive to reducing mortality, while non-essential postoperative ICU care in some patients was associated with the worst outcome.
At present, there is still a lack of accurate and reliable decision making system for postoperative admission to ICU for patients with digestive system malignancies at home and abroad.
Therefore, this project intends to establish a predictive model for postoperative ICU admission of patients with malignant tumors of the digestive system, develop a friendly interface that is convenient for medical care, help medical care quickly determine the biggest beneficiaries of postoperative ICU admission, rationally allocate medical resources, improve medical quality, reduce medical costs, ensure perioperative safety of patients, and promote postoperative rehabilitation of patients.
At present, there is still a lack of accurate and reliable decision making system for postoperative admission to ICU for patients with digestive system malignancies at home and abroad.
Therefore, this project intends to establish a predictive model for postoperative ICU admission of patients with malignant tumors of the digestive system, develop a friendly interface that is convenient for medical care, help medical care quickly determine the biggest beneficiaries of postoperative ICU admission, rationally allocate medical resources, improve medical quality, reduce medical costs, ensure perioperative safety of patients, and promote postoperative rehabilitation of patients.
Study Type
Observational
Enrollment (Actual)
2000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ningxia
-
Yinchuan, Ningxia, China, 750004
- General Hospital of Ningxia Medical University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients undergoing surgery for malignant tumors of digestive system under general anesthesia in Shaanxi Provincial Cancer Hospital and Ningxia Medical University General Hospital from January 2019 to December 2023
Description
Inclusion Criteria:
- Postoperative patients with malignant tumor of digestive system under general anesthesia, ASA Ⅱ~ Ⅳ
Exclusion Criteria:
- Emergency operation, operation stopped after entering the operating room, ASA > Ⅳ
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
observation group,
the risk factors of patients with malignant tumors of digestive system meeting the inclusion criteria were observed without special intervention
|
Related treatment or palliative surgery under general anesthesia for digestive system malignancies
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
admitted to ICU after surgery
Time Frame: the day and three days after surgery
|
whether the patient was admitted to ICU after surgery or within three days
|
the day and three days after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Liqin Deng, M.D, General Hospital of Ningxia Medical University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 20, 2023
Primary Completion (Estimated)
December 1, 2025
Study Completion (Estimated)
June 20, 2026
Study Registration Dates
First Submitted
February 19, 2024
First Submitted That Met QC Criteria
February 19, 2024
First Posted (Actual)
February 26, 2024
Study Record Updates
Last Update Posted (Actual)
February 26, 2024
Last Update Submitted That Met QC Criteria
February 19, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Liqin Deng
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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