NCT06057688

Brief Summary

The goal of this observational study is to establish an intelligent early warning system for acute and critical complications of the respiratory system such as pulmonary embolism and respiratory failure. Based on the electronic case database of the biomedical big data research center and the clinical real-world vital signs big data collected by wearable devices, the hybrid model architecture with multi-channel gated circulation unit neural network and deep neural network as the core is adopted, Mining the time series trends of multiple vital signs and their linkage change characteristics, integrating the structural nursing observation, laboratory examination and other multimodal clinical information to establish a prediction model, so as to improve patient safety, and lay the foundation for the later establishment of a higher-level and more comprehensive artificial intelligence clinical nursing decision support system. Issues addressed in this study

  1. 1.The big data of vital signs of patients collected in real-time by wearable devices were used to explore the internal relationship between the change trend of vital signs and postoperative complications (mainly including infection complications, respiratory failure, pulmonary embolism, cardiac arrest). Supplemented with necessary nursing observation, laboratory examination and other information, and use machine learning technology to build a prediction model of postoperative complications.
  2. 2.Develop the prediction model into software to provide auxiliary decision support for clinical medical staff, and lay the foundation for the later establishment of a higher-level and more comprehensive AI clinical decision support system.

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
1,770

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2023

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2023

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

August 7, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 28, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

September 28, 2023

Status Verified

September 1, 2023

Enrollment Period

1.2 years

First QC Date

August 7, 2023

Last Update Submit

September 24, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Unplanned ICU admission

    The patient was unplanned admitted to ICU due to pulmonary complications after operation

    During the whole hospitalization, the average was 7 days

Secondary Outcomes (1)

  • Death

    During the whole hospitalization, the average was 7 days

Eligibility Criteria

Age14 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Clinical information of patients in general surgery (gastrointestinal surgery, biliary surgery, pancreatic surgery)

You may qualify if:

  • aged from 14 to 90 years; ② Patients undergoing surgery under general anesthesia; ③ Informed consent to participate in this study

You may not qualify if:

  • The operation duration is less than 1 hour; ② Patients who cannot wear sensors for vital signs monitoring due to local skin abnormalities; ③ Combined with bilateral axillary surgery; ④ Incomplete bilateral axillary skin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West China Hospital, Sichuan University.

Chengdu, Sichuan, 610041, China

RECRUITING

MeSH Terms

Conditions

Pulmonary EmbolismRespiratory InsufficiencyHeart Arrest

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesRespiration DisordersHeart Diseases

Study Officials

  • GONG professor

    West China Hospital

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof.Gongrenrong

Study Record Dates

First Submitted

August 7, 2023

First Posted

September 28, 2023

Study Start

August 1, 2023

Primary Completion

October 1, 2024

Study Completion

December 31, 2024

Last Updated

September 28, 2023

Record last verified: 2023-09

Locations