Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06441760 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Simulation Trial of Telemedical Support for Paramedics

Study acronym: R01
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Minor Site details revised at 1 of 9 sitesv11
  2. Minor Study sites: 4 to 9
    • Secondary endpoints revised (6)
    v10
  3. Minor Start date changed from estimate of Jul 2025 to Jul 10, 2025v9
  4. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 1 to 4
    v8
  5. Minor 2 versions Re-verified since Sep 9, 2024, no change to tracked fieldsv6-v7
Show 4 earlier versionsHide 4 earlier versions
  1. Notable Start date: Jul 2024 to Jul 2025v5
  2. Minor Re-verified, no change to tracked fieldsv4
  3. Minor Trial status: Recruiting to Not Yet Recruiting
    • Start date: Jun 10, 2024 to Jul 2024
    • Site details revised
    v3
  4. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Jul 2024 to Jun 10, 2024
    v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
In the United States, the current standard of prehospital (i.e. outside of hospitals) emergency care for children with life-threatening illnesses in the community includes remote physician support for paramedics providing life-saving therapy while transporting the child to the hospital. Most prehospital emergency medical services (EMS) agencies use radio-based (audio only) communication between paramedics and physicians to augment this care. However, this communication strategy is inherently limited as the remote physician cannot visualize the patient for accurate assessment and to direct treatment. The purpose of this pilot randomized controlled trial (RCT) is to evaluate whether use of a 2-way audiovisual connection with a pediatric emergency medicine expert (intervention = "telemedical support") will improve the quality of care provided by paramedics to infant simulator mannequins with life threatening illness (respiratory failure). Paramedics receiving real-time telemedical support by a pediatric expert may provide better care due to decreased cognitive burden, critical action checking, protocol verification, and error correction. Because real pediatric life-threatening illnesses are rare, high stakes events and involve a vulnerable population (children), this RCT will test the effect of the intervention on paramedic performance in simulated cases of pediatric medical emergencies. The two specific aims for this research are: * Aim 1: To test the intervention efficacy by determining if there is a measurable difference in the frequency of serious safety events between study groups * Aim 2: To compare two safety event detection methods, medical record review, and video review
Trial Details
NCT Number NCT06441760
Lead Sponsor Boston Medical Center
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions
(from sponsor)
Emergencies, Cardiopulmonary Arrest, Acute Respiratory Failure, Status Epilepticus
Related terms Emergencies, Heart Arrest, Status Epilepticus
Enrollment 420 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov