Pulmonary EmbolismNCT06057688
Construction of Early Warning Model for Pulmonary Complications Risk of Surgical Patients Based on Multimodal Data Fusion
An observational study of Pulmonary Embolism and Respiratory Failure, run by Renrong Gong at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Embolism, Respiratory Failure, Infection Complication
- How many people
- 1,770 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2023to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 90 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Clinical information of patients in general surgery (gastrointestinal surgery, biliary surgery, pancreatic surgery)
Who may be able to join
- aged from 14 to 90 years; ② Patients undergoing surgery under general anesthesia; ③ Informed consent to participate in this study
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
West China Hospital, Sichuan University.
Chengdu, Sichuan, 610041
翠芳 曾, 13518109099, zengcuifang007@163.com
About this study
Official title: (Professor Gong Renrong) Ward Matron
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
- 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.
- 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.
Read the detailed description
The project prospectively collected the clinical information of patients in general surgery (gastrointestinal surgery, biliary surgery, pancreatic surgery), noninvasively monitored the patient's temperature, heart rate, ECG, respiratory rate through the body surface with wireless vital signs sensor, guided the patient to wear correctly from the first day of admission, and continuously monitored the patient's preoperative, intraoperative and postoperative vital signs throughout the whole process until leave hospital,The traditional "point" vital signs monitoring will be updated to continuous "line" monitoring, returning to the real world of patients' vital signs. The vital signs data of patients are continuously collected, transmitted in real-time and stored in the local central workstation of the ward, and the researchers of the project are specially assigned to be responsible for data export, storage and analysis. In view of the lack of early warning means for acute and critical complications in surgical ward, wearable devices with verified accuracy were used to collect continuous vital signs big data, fully mining the internal relationship between the change trend of patients' multiple vital signs parameters and complications, and establishing an intelligent risk warning model for perioperative complications of surgical patients, It lays the foundation for the establishment of a higher-level real-time patient risk warning and clinical decision support system, so as to improve the perioperative safety of patients and promote the penetration of artificial intelligence in clinical medicine and nursing.
Participants will use the Clavien Dindo grading criteria to determine the severity of complications according to the Cohort study method. According to whether the patient has experienced complications and the type of complications, the patient is divided into different subgroups and the patient outcome is manually calibrated. Mining the change trend of patient's vital signs over time, Convolutional neural network is used to extract morphological features from the continuous vital sign curves of the past 24 hours, and two-way short-term memory neural network is used to extract temporal features to obtain two sets of feature vectors. All data are feature fused, and sparse features are specially processed, and then sent to another weighted recurrent neural network to establish a complication prediction model, and predict the patient's Respiratory failure risk level, ICU risk level, and death risk level in the next 24 hours. Continuously revise the algorithm and set alarm threshold logic based on personal baseline data. Compare the predictive power of this model with the predictive power obtained from the national warning score NEWS, and determine the sensitivity, specificity, false positive rate, false negative rate, positive predictive value, and negative predictive value of the two in predicting patient outcomes.
- Medical subject headings
- Pulmonary Embolism, Respiratory Insufficiency, Heart Arrest
What is being measured
The primary outcome is the main question the study is designed to answer.
Unplanned ICU admission
The patient was unplanned admitted to ICU due to pulmonary complications after operation
Measured: During the whole hospitalization, the average was 7 days
Secondary outcomes (1)
Death
The patient died after surgery due to pulmonary complications
Measured: During the whole hospitalization, the average was 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start1 Aug 2023
- Primary completion1 Oct 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,770 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Renrong Gong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Renrong Gong, West China Hospital
- Investigators
- GONG professor, Study director, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06057688
- Sponsor's protocol ID
- ChiCTR2300072424
- Status last verified
- Sep 2023
- First submitted
- 7 Aug 2023
- Last updated
- 28 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- (Professor Gong Renrong) Ward Matron
- ClinicalTrials.gov ID
- NCT06057688
- Acronym / sponsor ID
- ChiCTR2300072424
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,770 participants (estimated)
- Lead sponsor
- Renrong GongUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 28 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
- 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.
Detailed description
The project prospectively collected the clinical information of patients in general surgery (gastrointestinal surgery, biliary surgery, pancreatic surgery), noninvasively monitored the patient's temperature, heart rate, ECG, respiratory rate through the body surface with wireless vital signs sensor, guided the patient to wear correctly from the first day of admission, and continuously monitored the patient's preoperative, intraoperative and postoperative vital signs throughout the whole process until leave hospital,The traditional "point" vital signs monitoring will be updated to continuous "line" monitoring, returning to the real world of patients' vital signs. The vital signs data of patients are continuously collected, transmitted in real-time and stored in the local central workstation of the ward, and the researchers of the project are specially assigned to be responsible for data export, storage and analysis. In view of the lack of early warning means for acute and critical complications in surgical ward, wearable devices with verified accuracy were used to collect continuous vital signs big data, fully mining the internal relationship between the change trend of patients' multiple vital signs parameters and complications, and establishing an intelligent risk warning model for perioperative complications of surgical patients, It lays the foundation for the establishment of a higher-level real-time patient risk warning and clinical decision support system, so as to improve the perioperative safety of patients and promote the penetration of artificial intelligence in clinical medicine and nursing.
Participants will use the Clavien Dindo grading criteria to determine the severity of complications according to the Cohort study method. According to whether the patient has experienced complications and the type of complications, the patient is divided into different subgroups and the patient outcome is manually calibrated. Mining the change trend of patient's vital signs over time, Convolutional neural network is used to extract morphological features from the continuous vital sign curves of the past 24 hours, and two-way short-term memory neural network is used to extract temporal features to obtain two sets of feature vectors. All data are feature fused, and sparse features are specially processed, and then sent to another weighted recurrent neural network to establish a complication prediction model, and predict the patient's Respiratory failure risk level, ICU risk level, and death risk level in the next 24 hours. Continuously revise the algorithm and set alarm threshold logic based on personal baseline data. Compare the predictive power of this model with the predictive power obtained from the national warning score NEWS, and determine the sensitivity, specificity, false positive rate, false negative rate, positive predictive value, and negative predictive value of the two in predicting patient outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 14 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Clinical information of patients in general surgery (gastrointestinal surgery, biliary surgery, pancreatic surgery)
Key inclusion criteria (1 listed)
- aged from 14 to 90 years; ② Patients undergoing surgery under general anesthesia; ③ Informed consent to participate in this study
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Unplanned ICU admission
Time frame: During the whole hospitalization, the average was 7 days
The patient was unplanned admitted to ICU due to pulmonary complications after operation
1 secondary outcome
Death
Time frame: During the whole hospitalization, the average was 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GONG professor study director
West China Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Embolism and Respiratory Failure, run by Renrong Gong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact GONG professor (+862885421887, gongrenrong@wchscu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unplanned ICU admission (time frame: During the whole hospitalization, the average was 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.