Respiratory Distress SyndromeNCT05967624
Prehospital Telemedicine Feasibility/Acceptability Pilot
A study testing Teleconsultation in people with Respiratory Distress Syndrome, run by Boston Medical Center at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Respiratory Distress Syndrome
- What is being tested?
- Teleconsultation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Jun 2024to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children in New England transported by the Boston Children Hospital for respiratory illness from any cause
- Clinically stable for transportation [e.g., need supplemental oxygen, medications, or are stable on mechanical ventilation]
Who cannot join
- Children with non-respiratory complaints
- Children whose illness is anticipated by providers to be acutely life-threatening during transportation [e.g., requiring emergency resuscitation procedures in the ambulance]
- Non-English speaking parents/guardians
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Boston Children's Hospital
Boston, Massachusetts, 02115
Boston Medical Center
Boston, Massachusetts, 02118
About this study
Official title: Feasibility and Acceptability of a Low-cost, Mobile Telemedicine Platform for Remote Assessment of Children Transported by Ambulance
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.
Read the detailed description
An open-label, nonrandomized, pilot feasibility trial will be conducted of children with respiratory distress transported by the Boston Children's Hospital (BCH) critical care transport team that also serves Boston Medical Center (BMC). Transport providers will initiate a video-call from the ambulance to medical control physician on call who will be at a geographically distant location. The physician will view streamed video of the child and complete a brief respiratory assessment checklist tool to determine video quality, a feasibility measure.
The investigators will measure acceptability (primary outcome) and feasibility (secondary outcomes) on a validated questionnaire administered to users after each call. In this pilot study, efficacy will not be tested; all decision making will occur according to usual care protocols.
- Conditions
- Respiratory Distress Syndrome
- Being tested
- Teleconsultation
- Keywords
- Teleconsultation
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeleconsultationOther
Each subject will be remotely assessed by a Medical Control Physician (MCP) using Zoom Pro (HIPAA-compliant video-conferencing software) on tablet devices as a low-cost mobile telemedicine platform and the Respiratory Observation Checklist, validated for telemedicine use in emergency settings. All prehospital clinical decision making will be made at the discretion of evaluating paramedics as per standard state-approved protocols and procedures, independent of checklist results.
| Study group | Role | What they receive |
|---|---|---|
| Teleconsultation group | Experimental | Eligible children managed by urban paramedic teams responding to 911 calls in the prehospital setting to support a future trial of clinical efficacy. Receives: Other: Teleconsultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement in Assessment of Respiratory Distress
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.
Measured: During transport to the hospital via ambulance, up to 4 hours
Secondary outcomes (10)
Total Usability Score
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 the usability of the study telemedicine platform. The range of the total usability score is 1-7. Low scores reflect a worse outcome, while high scores are a better outcome.
Measured: Immediately after the transport was completed, up to 48 hours
Video Quality
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.
Measured: Immediately after the transport was completed, up to 48 hours
Audio Quality
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.
Measured: immediately after the transport was completed, up to 48 hours
Adequacy of Successful Video-call Connections
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.
Measured: immediately after the transport was completed, up to 48 hours
Percentage of Successful Tablet Mounts
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.
Measured: Success/failure was assessed during transport, up to 4 hours
Percentage of Calls With Adequate Video Quality for Assessment
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).
Measured: during ambulance transport, up to 4 hours
Time to Arrival at Referring Facility
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.
Measured: up to 240 minutes
Scene Time
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.
Measured: up to 240 minutes
Time to Arrival at Destination Facility
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.
Measured: up to 240 minutes
Total Transport Time
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.
Measured: up to 240 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start21 Jun 2024
- Primary completion14 Feb 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Respiratory Distress SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Tehnaz Boyle, MD PhD, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05967624
- Sponsor's protocol ID
- H-38282
- Other IDs
- 5K23HL145126-03
- Status last verified
- Feb 2026
- First submitted
- 21 Jul 2023
- Last updated
- 19 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acceptability of a Low-cost, Mobile Telemedicine Platform for Remote Assessment of Children Transported by Ambulance
- ClinicalTrials.gov ID
- NCT05967624
- Acronym / sponsor ID
- H-38282
- Conditions
- Respiratory Distress Syndrome
- Keywords
- Teleconsultation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 21 Jun 2024 (actual)
- Primary completion
- 14 Feb 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 1 Aug 2023 (actual)
- Results
- Posted 19 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
An open-label, nonrandomized, pilot feasibility trial will be conducted of children with respiratory distress transported by the Boston Children's Hospital (BCH) critical care transport team that also serves Boston Medical Center (BMC). Transport providers will initiate a video-call from the ambulance to medical control physician on call who will be at a geographically distant location. The physician will view streamed video of the child and complete a brief respiratory assessment checklist tool to determine video quality, a feasibility measure.
The investigators will measure acceptability (primary outcome) and feasibility (secondary outcomes) on a validated questionnaire administered to users after each call. In this pilot study, efficacy will not be tested; all decision making will occur according to usual care protocols.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Teleconsultation group | Experimental | Other: TeleconsultationEligible children managed by urban paramedic teams responding to 911 calls in the prehospital setting to support a future trial of clinical efficacy. |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children in New England transported by the Boston Children Hospital for respiratory illness from any cause
- Clinically stable for transportation [e.g., need supplemental oxygen, medications, or are stable on mechanical ventilation]
Key exclusion criteria (3 listed)
- Children with non-respiratory complaints
- Children whose illness is anticipated by providers to be acutely life-threatening during transportation [e.g., requiring emergency resuscitation procedures in the ambulance]
- Non-English speaking parents/guardians
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TeleconsultationEach subject will be remotely assessed by a Medical Control Physician (MCP) using Zoom Pro (HIPAA-compliant video-conferencing software) on tablet devices as a low-cost mobile telemedicine platform and the Respiratory Observation Checklist, validated for telemedicine use in emergency settings. All prehospital clinical decision making will be made at the discretion of evaluating paramedics as per standard state-approved protocols and procedures, independent of checklist results. | Other | Teleconsultation group |
Primary outcome
Agreement in Assessment of Respiratory Distress
Time frame: 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.
10 secondary outcomes
Total Usability Score
Time frame: Immediately after the transport was completed, up to 48 hours
Video Quality
Time frame: Immediately after the transport was completed, up to 48 hours
Audio Quality
Time frame: immediately after the transport was completed, up to 48 hours
Adequacy of Successful Video-call Connections
Time frame: immediately after the transport was completed, up to 48 hours
Percentage of Successful Tablet Mounts
Time frame: Success/failure was assessed during transport, up to 4 hours
Percentage of Calls With Adequate Video Quality for Assessment
Time frame: during ambulance transport, up to 4 hours
Time to Arrival at Referring Facility
Time frame: up to 240 minutes
Scene Time
Time frame: up to 240 minutes
Time to Arrival at Destination Facility
Time frame: up to 240 minutes
Total Transport Time
Time frame: up to 240 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tehnaz Boyle, MD PhD principal investigator
Boston Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Teleconsultation in people with Respiratory Distress Syndrome, run by Boston Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement in Assessment of Respiratory Distress (time frame: During transport to the hospital via ambulance, up to 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026.