Two-way video support for paramedics caring for infants with life-threatening breathing problems.

Efficacy of Teleconsultation to Improve Prehospital Patient Safety for Critically Ill Infants and Children - A Multicenter, Simulation-based Randomized Control Trial

This project will test whether a two-way video link with pediatric emergency doctors helps paramedics give better care to infants with life-threatening breathing problems during transport.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 420 (estimated)
• Ages: 21 Years and up
• Sex: All
• Sponsor: Boston Medical Center (other)
• Locations: 4 sites (Aurora, Colorado and 3 other locations)
• Trial ID: NCT06441760 on ClinicalTrials.gov

What this trial studies

In a pilot randomized controlled simulation trial, paramedics will manage infant mannequin scenarios of respiratory failure while receiving either standard audio-only radio consultation or two-way audiovisual telemedical support from pediatric emergency medicine experts. Performance will be compared using objective quality-of-care measures such as timing and correctness of interventions in simulated prehospital scenarios. Certified EMTs/AEMTs/paramedics and board-certified PEM or EM physicians who provide online medical direction will participate, while resident physicians and non-physician providers are excluded. The work is conducted at multiple US academic centers in collaboration with NICHD to inform whether larger clinical trials are warranted.

Who should consider this trial

Good fit: Ideal candidates are front-line paramedics and the PEM/EM physicians who provide online medical direction at the participating EMS agencies and hospitals.

Not a fit: This approach is unlikely to benefit adults, patients handled by specialized pediatric transport teams, or emergencies in locations without reliable cellular/video connectivity.

Why it matters

Potential benefit: If successful, this approach could help paramedics deliver faster, more accurate lifesaving treatments to infants before they reach the hospital, potentially improving outcomes.

How similar studies have performed: Telemedicine in emergency care has improved decision-making and adherence to protocols in adults and in-hospital settings, but randomized evidence for pediatric prehospital telemedical support is limited.

Eligibility criteria

Inclusion Criteria:

* Certified Emergency Medical Technicians (EMTs), Advanced EMTs (AEMTs), and Paramedics (EMT-Ps) who provide direct scene response.
* Board-certified Pediatric Emergency Medicine (PEM) and Emergency Medicine (EM) physicians whose practice includes online medical support for EMS are eligible.
* The control arm will include physicians who provide radio/telephone support in usual care at each site. In the intervention arm, experts will be PEM with/without EMS board-certification as they have relevant pediatric training and experience.

Exclusion Criteria:

* EMS personnel providing interfacility transport and/or pediatric specialty transport
* Resident physicians-in-training
* Non-physician providers

Where this trial is running

Aurora, Colorado and 3 other locations

• Children's Hospital Colorado, University of Colorado Denver Anschutz Medical Campus — Aurora, Colorado, United States (NOT_YET_RECRUITING)
• Yale University — New Haven, Connecticut, United States (RECRUITING)
• BostonMedical Center — Boston, Massachusetts, United States (RECRUITING)
• University of Utah — Salt Lake City, Utah, United States (NOT_YET_RECRUITING)

Study contacts

• Principal investigator: Tehnaz Boyle, MD PhD — Bosotn Medical Center, Pediatrics Department
• Study coordinator: Tehnaz Boyle, MD PhD

Conditions: Emergencies, Cardiopulmonary Arrest, Acute Respiratory Failure, Status Epilepticus, Prehospital emergency care, Emergency medical services, Paramedics, Infant simulator mannequins