- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07546474
Telemedicine-Assisted vs Conventional Telephone Instruction in Cardiopulmonary Resuscitation (TACTIC)
Out-of-hospital cardiac arrest (OHCA) is a life-threatening emergency where early cardiopulmonary resuscitation (CPR) by bystanders can significantly improve survival. Emergency dispatchers often guide bystanders to perform CPR over the phone, a method known as dispatcher-assisted CPR (DA-CPR). While this approach has increased bystander CPR rates worldwide, it relies on voice communication only, which may limit the dispatcher's ability to assess the situation and guide CPR effectively.
With advances in telecommunication technology, video-based communication has become more widely available. Telemedicine-assisted CPR (TA-CPR) allows dispatchers or emergency medical providers to see the patient and the rescuer through a live video call, potentially improving CPR performance by providing real-time visual feedback. However, evidence on whether this approach improves outcomes in real-world emergency medical service (EMS) systems is still limited.
This study aims to compare the effectiveness of TA-CPR with conventional DA-CPR in adult patients with suspected non-traumatic OHCA. The study is designed as a pragmatic cluster-randomized controlled trial conducted within a hospital-based EMS system in Bangkok, Thailand. Instead of randomizing individual patients, the CPR instruction protocol is assigned by month (cluster randomization). During each month, all eligible patients receive either the TA-CPR protocol or the DA-CPR protocol.
In both groups, CPR instructions are first provided through voice communication to avoid delaying the start of chest compressions. In the TA-CPR group, responders may switch to video communication if it is feasible, depending on factors such as the caller's device capability and the availability of another person to hold the camera. In the DA-CPR group, only voice communication is used throughout.
The study includes adult patients (aged 18 years or older) with suspected non-traumatic cardiac arrest who are managed by the participating EMS unit. Patients are excluded if resuscitation is declined, if the location is unsafe, if the cardiac arrest is witnessed by EMS personnel, or if communication barriers prevent CPR instructions.
The primary outcome of the study is the proportion of patients who receive bystander CPR before EMS arrival. Secondary outcomes include whether bystanders continue chest compressions until EMS arrives, how well responders follow the assigned protocol, and selected patient outcomes such as return of spontaneous circulation and survival.
Data are collected from an EMS cardiac arrest registry and hospital medical records. Audio recordings of dispatcher and responder communications are reviewed to assess adherence to the study protocols. The results of this study will help determine whether adding video communication to dispatcher-assisted CPR provides additional benefit in real-world EMS settings and inform future implementation of telemedicine in emergency care systems.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Bangkok
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Bangkok Noi, Bangkok, Thailand, 10700
- Faculty of Medicine Siriraj Hospital, Mahidol University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adult patients aged ≥18 years
- Suspected non-traumatic out-of-hospital cardiac arrest
- Managed by the participating advanced life support (ALS) EMS unit
Exclusion Criteria:
- Resuscitation declined by patient's relatives
- Cardiac arrest occurring in unsafe or inappropriate locations for EMS intervention
- EMS-witnessed cardiac arrest
- Inability of bystander to communicate in Thai
- Cases where ALS unit is not directly dispatched to the scene
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Telemedicine-Assisted CPR (TA-CPR)
Participants receive prearrival cardiopulmonary resuscitation (CPR) instructions provided by emergency medical service (EMS) personnel using a telemedicine-assisted approach.
CPR instructions are initiated using audio (telephone) communication to avoid delays in chest compression initiation.
Following initial instruction, EMS personnel assess the feasibility of establishing real-time video communication based on device capability, internet connectivity, and the availability of an additional bystander to assist with video transmission.
When feasible, CPR guidance is continued with live video support to provide real-time visual feedback.
If video communication cannot be established, CPR instructions continue via audio only.
|
Participants receive dispatcher or EMS-guided cardiopulmonary resuscitation (CPR) with an initial audio-based instruction followed by real-time video communication when feasible.
Video guidance is implemented based on device capability, connectivity, and availability of an additional bystander to assist with video transmission.
If video is not feasible, CPR instructions continue via audio.
|
|
Active Comparator: Dispatcher-Assisted CPR (DA-CPR)
Participants receive conventional prearrival cardiopulmonary resuscitation (CPR) instructions provided by emergency medical service (EMS) personnel using audio-only (telephone) communication.
CPR guidance is delivered continuously via voice without the use of video communication throughout the prehospital period.
|
Participants receive conventional dispatcher-assisted CPR instructions delivered exclusively via audio (telephone communication) without the use of video support.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Bystander CPR rate
Time Frame: From enrollment to the end of resuscitation at 1 day
|
Proportion of patients with suspected out-of-hospital cardiac arrest who receive cardiopulmonary resuscitation from a bystander prior to EMS arrival
|
From enrollment to the end of resuscitation at 1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Ongoing bystander CPR at EMS arrival
Time Frame: From enrollment to the end of resuscitation at 1 day
|
Proportion of patients receiving continuous chest compressions by bystanders at the time EMS arrives
|
From enrollment to the end of resuscitation at 1 day
|
|
Protocol compliance
Time Frame: From enrollment to the audit protocol at 4 weeks
|
Proportion of cases in which EMS personnel adhere to all required steps of the assigned CPR instruction protocol (including successful video use in TA-CPR when applicable)
|
From enrollment to the audit protocol at 4 weeks
|
|
Return of spontaneous circulation (ROSC) at emergency department
Time Frame: From enrollment to the end of resuscitation at 1 day
|
Return of spontaneous circulation (ROSC) at emergency department
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From enrollment to the end of resuscitation at 1 day
|
|
Survival to hospital admission
Time Frame: During hospitalization (assessed up to 5 days)
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During hospitalization (assessed up to 5 days)
|
|
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Survival to hospital discharge
Time Frame: During hospitalization (assessed up to 24 weeks)
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During hospitalization (assessed up to 24 weeks)
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Lee SY, Song KJ, Shin SD, Hong KJ, Kim TH. Comparison of the effects of audio-instructed and video-instructed dispatcher-assisted cardiopulmonary resuscitation on resuscitation outcomes after out-of-hospital cardiac arrest. Resuscitation. 2020 Feb 1;147:12-20. doi: 10.1016/j.resuscitation.2019.12.004. Epub 2019 Dec 13.
- Lin YY, Chiang WC, Hsieh MJ, Sun JT, Chang YC, Ma MH. Quality of audio-assisted versus video-assisted dispatcher-instructed bystander cardiopulmonary resuscitation: A systematic review and meta-analysis. Resuscitation. 2018 Feb;123:77-85. doi: 10.1016/j.resuscitation.2017.12.010. Epub 2017 Dec 12.
- Nikolaou N, Dainty KN, Couper K, Morley P, Tijssen J, Vaillancourt C; International Liaison Committee on Resuscitation's (ILCOR) Basic Life Support and Pediatric Task Forces. A systematic review and meta-analysis of the effect of dispatcher-assisted CPR on outcomes from sudden cardiac arrest in adults and children. Resuscitation. 2019 May;138:82-105. doi: 10.1016/j.resuscitation.2019.02.035. Epub 2019 Mar 8.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SI821/2024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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