"Critical State" Early Warning Score After CHD Surgery and Rapid Response Team

NCT ID: NCT06578312

Last Updated: 2024-08-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 4115 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2024-07-01

Brief Summary

By establishing a warning scoring tool for the early "critical state" after congenital heart disease surgery, the multidisciplinary rapid response team is proactively activated, forming an integrated treatment model of early warning-team decision-making-organ assistance.

Detailed Description

All children aged 0-14 years admitted to the PICU from 2021-2022 were enrolled continuously, and their baseline data such as gender, age, RACHS-1 score, cardiopulmonary bypass time, aortic clamping time, whether there was chromosomal lesions, whether there was preoperative endotracheal intubation/heart failure, changes in oxygenation index, lactate, and vasoactive drug scores were obtained. All variables that may lead to composite malignant events including death in the early postoperative period were included, including death, pulmonary hypertension crisis, malignant arrhythmias (supraventricular tachycardia, ventricular tachycardia, ventricular fibrillation, high-degree atrioventricular block) requiring antiarrhythmic drugs or pacemaker treatment, cardiopulmonary resuscitation, ECPR, emergency sternal expansion, severe AKI, severe ARDS, neurological complications (cerebral hemorrhage, cerebral infarction), gastrointestinal complications (gastrointestinal bleeding, intestinal obstruction, intestinal necrosis).The variables were included in the machine learning analysis to establish the model.

Conditions

Congenital Heart Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• pediatrics admitted to ICU

Exclusion Criteria

• surgery without cardiopulmonary bypass
• neonatal
• using extra-corporeal circulation during surgery
• Delayed chest closing during surgery

• Minimum Eligible Age: 28 Days
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese Academy of Medical Sciences, Fuwai Hospital

OTHER

Sponsor Role: lead

Responsible Party

Xu Wang

Chief Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xu Wang

Role: PRINCIPAL_INVESTIGATOR

Chinese Academy of Medical Sciences, Fuwai Hospital

Locations

Fuwai hospital

Beijing, , China

Countries

China

Other Identifiers

2022-GSP-GG-32

Identifier Type: -

Identifier Source: org_study_id