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

Taipei Veterans General Hospital

Status: Not yet enrolling

Conditions: Postoperative Complications (Cardiopulmonary); Treatment Outcomes; Pre-operative Assessment; Pulmonary Hypertension (Diagnosis)

Treatments: Diagnostic Test: Artificial Intelligence-Enabled Electrocardiography System

Study type: Interventional

Funder types: Other

Identifiers

NCT07344207

2025-10-004CCF

Details and patient eligibility

About

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.

Full description

This is an open-label, prospective, randomized controlled trial at Taipei Veterans General Hospital. Approximately 1,380 adult patients who already have a preoperative electrocardiogram (ECG) scheduled as part of routine care and have an established plan for elective surgery will be enrolled, along with approximately 30-60 participating physicians responsible for preoperative assessment and perioperative clinical care. The study evaluates whether integrating the Taiwan Medical Imaging Pulmonary Hypertension Detection System (TAIMedImg PHDS), an ECG-based clinical decision-support tool, during the preoperative preparation period can enable earlier identification of patients at risk of pulmonary hypertension and cardiopulmonary complications, and supports assessment of the potential cost-effectiveness of earlier risk recognition.

Patients are randomized to determine whether their responsible participating physician will receive TAIMedImg PHDS output derived from the patient's routine ECG. In the intervention arm, research staff upload the ECG to TAIMedImg PHDS and provide the analysis result to the participating physician; all other processes proceed as usual care. In the control arm, usual care proceeds without provision of TAIMedImg PHDS output. Randomization affects only access to this supplementary ECG-based output; it does not change patients' scheduled tests, clinical workflow, or rights to care. Clinical evaluation and management remain at the physician's discretion according to standard practice.

The study measures physicians' responses to ECG interpretation with versus without TAIMedImg PHDS output and documents the clinical decision-making trajectory, using routinely available medical record data for analysis. Results may inform improved preoperative pulmonary hypertension risk assessment and future perioperative care.

Enrollment: 1,380 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age between 18 and 80 years.
2. Patients scheduled for non-cardiac surgery under general anesthesia.
3. Patients who have a scheduled standard preoperative electrocardiogram (ECG).
4. Patients capable of understanding the study and willing to provide medical records for research purposes, and who have signed the informed consent form.

Exclusion criteria

1. Patients scheduled for emergency surgery.
2. Patients who explicitly refuse to participate or withdraw consent.
3. Patients with specific comorbidities that interfere with ECG interpretation or data collection (e.g., implanted pacemakers).

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

1,380 participants in 2 patient groups

AI-ECG Screening Group

Experimental group

Description:

The physician responsible for the participant in this arm will receive the results generated by the artificial intelligence-enabled electrocardiography (AI-ECG) system for pulmonary hypertension.

Treatment:

Diagnostic Test: Artificial Intelligence-Enabled Electrocardiography System

Standard of Care Group

No Intervention group

Description:

The physician responsible for the participant in this arm will not receive the results generated by the artificial intelligence-enabled electrocardiography (AI-ECG) system for pulmonary hypertension.