Under 17, any sex, with Respiratory Distress Syndrome. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Agreement in Assessment of Respiratory DistressPrimary· During transport to the hospital via ambulance, up to 4 hours
Each subject will be remotely assessed by a Medical Control Physician using the HIPAA-compliant Zoom Pro web application pre-loaded on a tablet device. The remote medical control physician and the transport team member at the patient bedside in the ambulance will score the Respiratory Observation Checklist simultaneously. The range for agreement is 0 to 1.0, where 0=no agreement and 1 is perfect agreement. The following scale: 0.01-0.20=none to slight, 0.21-0.40=fair, 0.41-0.60=moderate, 0.61-0.80=substantial, 0.81-1.0=almost perfect agreement will be used.
Group
Value
95% CI
Teleconsultation Group
0.83
0.58 – 0.96
Total Usability ScoreSecondary· Immediately after the transport was completed, up to 48 hours
The total usability score is measured by the Telehealth Usability Questionnaire (TUQ), a 21-item questionnaire which is a validated measure of all the key usability characteristics of telehealth platforms (usefulness, ease of use, effectiveness, reliability, and satisfaction). Users \[transport nurses and physicians\] rate items on 7-point Likert-scales (1=disagree to 7=agree) in 6 separate domains (usefulness, ease of use and learnability, interface quality, interaction quality, reliability, satisfaction and future use). The investigators modified this questionnaire to specifically address th
Nurses
Group
Value
95% CI
Teleconsultation Group
6
± 0.9
Physicians
Group
Value
95% CI
Teleconsultation Group
5.7
± 0.7
Video QualitySecondary· Immediately after the transport was completed, up to 48 hours
This will be measured by TUQ items #11 and #14 within the "Interaction Quality" domain. Users \[transport nurses and physicians\] will rate each item on a 7-point Likert-scale (1=disagree to 7=agree), so scores will range from 1 to 7. The mean score and standard deviation (SD) for each item will be reported. Higher scores suggest higher quality.
Nurses- "I could easily talk to the patient/clinician using the telemedicine system."
Group
Value
95% CI
Teleconsultation Group
6.6
± 0.8
Physicians- "I could easily talk to the patient/clinician using the telemedicine system".
Group
Value
95% CI
Teleconsultation Group
6.2
± 0.8
Nurses- "Using the telemedicine system, I can see the patient/clinician as if we met in person."
Group
Value
95% CI
Teleconsultation Group
6.2
± 1.3
Physicians- "Using the telemedicine system, I can see the patient/clinician as if we met in person."
Group
Value
95% CI
Teleconsultation Group
3.9
± 1.3
Audio QualitySecondary· immediately after the transport was completed, up to 48 hours
This will be measured by TUQ items #12 and #13 within the "Interaction Quality" domain. Users \[transport nurses and physicians\] will rate each item on a 7-point Likert-scale (1=disagree to 7=agree), so scores will range from 1 to 7. The mean score and SD for each item will be reported. Higher scores suggest higher quality.
Nurses- "I could hear the patient/clinician easily using the telemedicine system."
Group
Value
95% CI
Teleconsultation Group
6.3
± 1.2
Physicians- "I could hear the patient/clinician easily using the telemedicine system."
Group
Value
95% CI
Teleconsultation Group
6.2
± 0.9
Nurses- "I felt I was able to express myself effectively."
Group
Value
95% CI
Teleconsultation Group
6.9
± 0.3
Physicians- "I felt I was able to express myself effectively."
Group
Value
95% CI
Teleconsultation Group
6.1
± 0.8
Adequacy of Successful Video-call ConnectionsSecondary· immediately after the transport was completed, up to 48 hours
The number of attempts transport team providers make to successfully connect with the medical control physician via video-call will be recorded. Adequacy of successful video-call connection is defined as ≤2 attempts to achieve a video-call connection.
Adequate (≤2 attempts)
Group
Value
95% CI
Teleconsultation Group
14
Inadequate (>2 attempts)
Group
Value
95% CI
Teleconsultation Group
6
Percentage of Successful Tablet MountsSecondary· Success/failure was assessed during transport, up to 4 hours
Study investigators will note any problems with tablet mounts in the ambulance cabin (e.g., location makes call activation difficult), as well as specific qualitative comments from participants regarding tablet mount strategy. If no problems are noted the tablet mount will be considered successful and the percentage of successful table mounts will be reported.
Successful
Group
Value
95% CI
Teleconsultation Group
100
Not successful
Group
Value
95% CI
Teleconsultation Group
0
Percentage of Calls With Adequate Video Quality for AssessmentSecondary· during ambulance transport, up to 4 hours
This will be measured as the proportion of video-calls where clinicians are able to observe all ten items on the Respiratory Observation Checklist. This checklist tool has been previously validated for rapid, reliable assessment of children by teleconsultants in emergency settings. Medical control physicians will score 9 observable signs and a global assessment of respiratory distress dichotomously (present/absent).
Optimal video quality for assessment
Group
Value
95% CI
Teleconsultation Group
33.3
Video quality not optimal for assessment
Group
Value
95% CI
Teleconsultation Group
66.7
Time to Arrival at Referring FacilitySecondary· up to 240 minutes
This is the time interval (minutes) from when BCH receives the patient transport request from the referring facility to the time the transport team arrives at the referring facility. This will be abstracted from transport records.
Group
Value
95% CI
Teleconsultation Group
66.0
50.0 – 78.5
Scene TimeSecondary· up to 240 minutes
This is the time interval (minutes) from when the BCH transport team arrives at the referring facility to when the transport team leaves the referring facility. This will be abstracted from transport records.
Group
Value
95% CI
Teleconsultation Group
51.5
42.0 – 56.0
Time to Arrival at Destination FacilitySecondary· up to 240 minutes
This is the time interval (minutes) from when the BCH transport team leaves the referring facility to the time of arrival at BCH/BMC (the destination facility). This will be abstracted from transport records.
Group
Value
95% CI
Teleconsultation Group
58.5
49.0 – 70.5
Total Transport TimeSecondary· up to 240 minutes
This time interval encompasses the time from when the transport team is dispatched to the referring facility to when they arrive at the destination (receiving facility). This will be abstracted from transport records.
Group
Value
95% CI
Teleconsultation Group
173.5
159.0 – 202.5
Sponsor's own description
Teleconsultation, or the use of video telecommunications technology to deliver expert recommendations for care remotely, has been used to improve the safety and quality of emergency care for children in hospital-based acute care settings by providing real-time access to remote pediatric physician experts. Whether extending teleconsultation as a patient safety intervention to emergency medical systems (EMS) outside hospitals can similarly benefit sick and injured children in the community is unknown. Advances in mobile technology have made teleconsultation more accessible and affordable for EMS systems. However, this intervention has been underutilized by EMS partially due to the lack of prehospital research supporting its efficacy for pediatric applications.
In prior simulation studies, the investigators found high intervention acceptance among key stakeholder groups (pediatric emergency physicians and paramedics), and demonstrated that it was feasible to integrate video communication into prehospital clinical workflows involving critical care delivery in high-risk pediatric scenarios. These initial simulation studies were conducted in a controlled prehospital setting in static ambulances using infant simulator manikins to minimize risk to children and providers. Demonstrating feasibility and acceptability with real children in moving ambulances is the next step to build the necessary evidence base to support future planned prehospital efficacy trials with children.
The investigators hypothesize that remote respiratory assessment of children by medical control physicians (expert physicians) using a mobile teleconsultation platform is acceptable to users (physicians and transport providers), and technically feasible in real transports.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
NCT06365177 — Evaluation of the Concordance of Five Times Sit To Stand Results Between a Physical Consultation and a Teleconsultation
· NA
· recruiting
NCT04497259 — Follow-up of Bariatric Surgery by Teleconsultations
· NA
· recruiting
NCT06272344 — Remote Programming of Cardiac Implantable Electronic Devices 2
· NA
· completed
NCT05633784 — Telemedicine Home-based Management in Patients With CHF and Type 2 Diabetes
· NA
· completed
NCT05241951 — Preventing Medication-Related Problems in Care Transitions to Skilled Nursing Facilities
· NA
· completed
Other recruiting trials for Respiratory Distress Syndrome
Currently open trials in the same condition.
NCT07437391 — Effect of L-Carnitine Supplementation in Preterm Neonates
· NA
· recruiting
NCT06807983 — LUng and Cardiac Ultrasound for REspiratory Distress in ElDerly
· NA
· recruiting
NCT07154134 — Endocan and Copeptin Serum Levels in Preterm Neonates With Respiratory Distress Syndrome
· recruiting
NCT06684379 — Study on Safety and Efficacy of Two Doses of PRS CK STORM in the Modulation of the Cytokine Storm for the Treatment of A
· Phase 1, PHASE2
· recruiting
NCT06430554 — Personalized Ventilation Based on Ventilation-perfusion Mismatch and Lung Recruitability
· recruiting
Other Boston Medical Center trials
Trials by the same sponsor.
NCT06679114 — Preventing Mental Disorders Among Women Internally Displaced by War in Ukraine: The SHAWL Trial
· NA
· completed
NCT06093893 — Hypotensive Anesthesia for Orthognathic Surgery
· Phase 4
· completed
NCT06489522 — Parenting Intervention for Mothers With Substance Use Disorder
· NA
· completed
NCT05769218 — PrEP and MOUD Rapid Access for Persons Who Inject Drugs: The CHORUS+ Study
· NA
· recruiting
NCT06427967 — A Novel Social Emotional Learning Curriculum for Youth With Epilepsy
· NA
· completed
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Boston Medical Center
Last refreshed: 19 February 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05967624.