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GUARD-PH: Guided Use of AI-ECG for Risk Detection of PH in Surgery (GUARD-PH Trial)

ConditionsPulmonary Hypertension (Diagnosis)Pre-operative AssessmentPostoperative Complications (Cardiopulmonary)Treatment Outcomes
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTaipei Veterans General Hospital, Taiwan

About this trial

This study is a prospective, open-label, randomized controlled trial designed to evaluate a new artificial intelligence (AI) tool for heart monitoring. Researchers will use an AI-enabled electrocardiography (ECG) system to screen patients before they undergo surgery. The main goal is to determine if this AI system can accurately detect pulmonary hypertension and related heart diseases in the preoperative setting. The study is being conducted at Taipei Veterans General Hospital.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age between 18 and 80 years.

Patients scheduled for non-cardiac surgery under general anesthesia.

Patients who have a scheduled standard preoperative electrocardiogram (ECG).

Patients capable of understanding the study and willing to provide medical records for research purposes, and who have signed the informed consent form.

Disqualifiers

Patients scheduled for emergency surgery.

Patients who explicitly refuse to participate or withdraw consent.

Patients with specific comorbidities that interfere with ECG interpretation or data collection (e.g., implanted pacemakers).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Artificial Intelligence-Enabled Electrocardiography System

    Diagnostic test

    The intervention involves using an artificial intelligence-enabled electrocardiography system to analyze standard ECGs for the preoperative detection of pulmonary hypertension.

Treatment groups

1,380 Participants
are divided into 2 treatment groups
Group A: AI-ECG Screening GroupExperimental treatment 1 intervention
Group B: Standard of Care GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

The incidence of newly diagnosed pulmonary hypertension or pulmonary hypertension-related cardiopulmonary diseases

The incidence of newly diagnosed pulmonary hypertension (defined as an echocardiographic right ventricular systolic pressure \> 50 mmHg) or pulmonary hypertension-related cardiopulmonary diseases before surgery, or within 90 days after electrocardiography in patients who did not undergo surgery.

Time frame
Before surgery, or within 90 days after electrocardiography in patients who did not undergo surgery.

Secondary outcomes

1

Incidence of Surgical Complications

Comparison of the incidence rates of surgical complications between the two groups.

Time frame
From the date of surgery up to 3 months post-operation.
2

Length of Hospital Stay

Comparison of the total duration of hospitalization (in days) between the intervention and control groups.

Time frame
From admission until hospital discharge (assessed up to 3 months).
3

Cardiovascular Mortality

Evaluation of the rates of cardiovascular-related death between the two groups during the postoperative observation period.

Time frame
From the date of surgery up to 3 months post-operation.
4

All-Cause Mortality

Evaluation of the rates of all cause mortality between the two groups during the postoperative observation period.

Time frame
From the date of surgery up to 3 months post-operation.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Taipei Veterans General Hospital, Taiwan

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: