Respiratory Distress SyndromeNCT04168554
Telemedicine in the Generals Practitioners Office
An observational study of Respiratory Distress Syndrome and Pneumonia, run by Rijnstate Hospital.
Trial summary
Pediatrician does physical examination through telemedicine and in real life to see whether the telemedicine consultation corresponds with the real life examination. Goal is to determine: 1. Check practical feasability 2. Check whether there are no great objections for a larger study (ie. Read more about this study
- Who is it for?
- Ages 3 months to 18 years
- Conditions the study is for
- Respiratory Distress Syndrome, Pneumonia, Bronchiolitis
- What is being tested?
- Telemedicine
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Dec 2019to Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 3 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric patients with any type of respiratory disease
Who may be able to join
- Pediatric patients with respiratory symptoms whom are referred by a general practitioner to be evaluated by a pediatrician
Who cannot join
- Infants younger than 2 months of age
- 19 years and older
- Ex-premature with post-conceptional age <48 weeks
- Congenital heart disease
- Down Syndrome
- Immune deficiency
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- Pre-existent pulmonary disorder (Broncho-pulmonary dysplasia, Cystic Fibrosis)
- Pre-existent neurological disorders
- Apnea's
- Patients with respiratory distress with dehydration symptoms
- Patients who have already been treated with salbutamol inhalers of nebulizer - Emergency patient with respiratory insufficiency
- Technical problems which cause a delay longer than 10 minutes before a video-connection is made
- expected delay before commencing telemedicine consultation of longer than 30 minutes
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Pilotonderzoek Naar Het Gebruik Van Telemedicine Bij Het Beoordelen Van Het Benauwde Kind in de Huisartsenpraktijk English: The Use of Telemedicine in the General Practitioners Office for a Child With Respiratory Symptoms: a Pilot Study
Pediatrician does physical examination through telemedicine and in real life to see whether the telemedicine consultation corresponds with the real life examination.
Goal is to determine:
- Check practical feasability
- Check whether there are no great objections for a larger study (ie. in case telemedicine consultation is much more unreliable to do a physical examination a larger study is deemed unsafe)
Read the detailed description
40 pediatric patients seen by a general practitioner (GP) whom the GP has referred or wants to refer to a pediatrician for clinical evaluation are included in this study.
Study is designed in 2 parts. Part 1 is at the emergency room in the hospital Part 2 is at the GPs office
The pediatrician sees the patient through a telemedicine consultation. Then sees the patient in real life to see if what was seen during telemedicine corresponds with the real life consultation.
With telemedicine and real life consultation the pediatrician rates the patient as either a candidate to go home or to be admitted. With the telemedicine consultation there is also an option "in doubt: i want to see the patient in real life".
Also with both telemedicine and real life examination the pediatrician scores the patient using the respiratory observation scale (Siew et al, 2016)
Goal is to:
- Check practical feasability
- Check whether there are no great objections for a larger study (ie. in case telemedicine consultation is much harder to do a physical examination
- Conditions
- Respiratory Distress Syndrome, Pneumonia, Bronchiolitis, Croup, Croup; False, Asthma
- Being tested
- Telemedicine
- Keywords
- Telemedicine, Respiratory distress, Pediatric, General practitioner
- Medical subject headings
- Respiratory Distress Syndrome, Pneumonia, Bronchiolitis, Croup, Asthma, Bronchial Hyperreactivity, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelemedicineDevice
Patient is examined using telemedicine
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 and Phase 2 | 20 patients studied in the emergency room with a pediatrician not presen in the ER performing the telemedicine examination from a distance (ie an office down the hall) followed directly by a face-to-face
20 patients included in the general practitioners office, telemedicine is performed from within the hospital to the GPs office.
Patient is then still referred to the hospital in order to check whether the telemedicine and face-to-face examination are somewhat similarce physical examination Receives: Device: Telemedicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Discharge or admitted?
Patients are categorized in one of three categories through telemedicine-evaluation Group 1: "Patient can safely go home" Group 2: "Patient will need to be admitted" Group 3: "In doubt between group 1 and group 2, emergency room consultation required" FTF evaluation: Group 1: "Patient can safely go home" Group 2: "Patient will need to be admitted"
Measured: within 30-60 minutes after inclusion
Respiratory Observation Scale
Observe the presence of: tachypnea, nasal flaring, perioral cyanosis, tripoding, thoracoabdominal asynchrony, supraclavicular-, substernal- or intercostal retractions, mental status and patient in respiratory distress
Measured: within 30-60 minutes after inclusion
Secondary outcomes (2)
Patient reported experience measure
questionnaire on patient / parent satisfaction with regard to the telemedicine
Measured: within 60 minutes after telemedicine evaluation
Doctor reported experience measure
Interview with participating doctors with regard to satisfaction of the telemedicine
Measured: within 4 weeks after inclusion of patients
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2019
- Study startDec 2019 (estimated)
- Primary completionNov 2020 (estimated)
- Study completionNov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rijnstate Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Margreet Wessels, MD, PhD, Principal investigator, Rijnstate Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04168554
- Sponsor's protocol ID
- 2019-1384
- Status last verified
- Nov 2019
- First submitted
- 11 Nov 2019
- Last updated
- 19 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Siew L, Hsiao A, McCarthy P, Agarwal A, Lee E, Chen L. Reliability of Telemedicine in the Assessment of Seriously Ill Children. Pediatrics. 2016 Mar;137(3):e20150712. doi: 10.1542/peds.2015-0712. Epub 2016 Feb 5.
PubMed 26908666
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilotonderzoek Naar Het Gebruik Van Telemedicine Bij Het Beoordelen Van Het Benauwde Kind in de Huisartsenpraktijk English: The Use of Telemedicine in the General Practitioners Office for a Child With Respiratory Symptoms: a Pilot Study
- ClinicalTrials.gov ID
- NCT04168554
- Acronym / sponsor ID
- 2019-1384
- Conditions
- Respiratory Distress Syndrome, Pneumonia, Bronchiolitis, Croup, Croup; False, Asthma
- Keywords
- Telemedicine, Respiratory distress, Pediatric, General practitioner
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Rijnstate HospitalUniversity, hospital or other
- Study start
- Dec 2019 (estimated)
- Primary completion
- Nov 2020 (estimated)
- Study completion
- Nov 2020 (estimated)
- First posted
- 19 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pediatrician does physical examination through telemedicine and in real life to see whether the telemedicine consultation corresponds with the real life examination.
Goal is to determine:
- Check practical feasability
- Check whether there are no great objections for a larger study (ie. in case telemedicine consultation is much more unreliable to do a physical examination a larger study is deemed unsafe)
Detailed description
40 pediatric patients seen by a general practitioner (GP) whom the GP has referred or wants to refer to a pediatrician for clinical evaluation are included in this study.
Study is designed in 2 parts. Part 1 is at the emergency room in the hospital Part 2 is at the GPs office
The pediatrician sees the patient through a telemedicine consultation. Then sees the patient in real life to see if what was seen during telemedicine corresponds with the real life consultation.
With telemedicine and real life consultation the pediatrician rates the patient as either a candidate to go home or to be admitted. With the telemedicine consultation there is also an option "in doubt: i want to see the patient in real life".
Also with both telemedicine and real life examination the pediatrician scores the patient using the respiratory observation scale (Siew et al, 2016)
Goal is to:
- Check practical feasability
- Check whether there are no great objections for a larger study (ie. in case telemedicine consultation is much harder to do a physical examination
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Phase 1 and Phase 2 | – | Device: Telemedicine20 patients studied in the emergency room with a pediatrician not presen in the ER performing the telemedicine examination from a distance (ie an office down the hall) followed directly by a face-to-face 20 patients included in the general practitioners office, telemedicine is performed from within the hospital to the GPs office. Patient is then still referred to the hospital in order to check whether the telemedicine and face-to-face examination are somewhat similarce physical examination |
Who may qualify
- Ages
- 3 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric patients with any type of respiratory disease
Key inclusion criteria (1 listed)
- Pediatric patients with respiratory symptoms whom are referred by a general practitioner to be evaluated by a pediatrician
Key exclusion criteria (13 listed)
- Infants younger than 2 months of age
- 19 years and older
- Ex-premature with post-conceptional age <48 weeks
- Congenital heart disease
- Down Syndrome
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 |
|---|---|---|
| TelemedicinePatient is examined using telemedicine | Device | Phase 1 and Phase 2 |
Primary outcome
Discharge or admitted?
Time frame: within 30-60 minutes after inclusion
Patients are categorized in one of three categories through telemedicine-evaluation Group 1: "Patient can safely go home" Group 2: "Patient will need to be admitted" Group 3: "In doubt between group 1 and group 2, emergency room consultation required" FTF evaluation: Group 1: "Patient can safely go home" Group 2: "Patient will need to be admitted"
Respiratory Observation Scale
Time frame: within 30-60 minutes after inclusion
Observe the presence of: tachypnea, nasal flaring, perioral cyanosis, tripoding, thoracoabdominal asynchrony, supraclavicular-, substernal- or intercostal retractions, mental status and patient in respiratory distress
2 secondary outcomes
Patient reported experience measure
Time frame: within 60 minutes after telemedicine evaluation
Doctor reported experience measure
Time frame: within 4 weeks after inclusion of patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2019.
- Background: PubMed 26908666Siew L, Hsiao A, McCarthy P, Agarwal A, Lee E, Chen L. Reliability of Telemedicine in the Assessment of Seriously Ill Children. Pediatrics. 2016 Mar;137(3):e20150712. doi: 10.1542/peds.2015-0712. Epub 2016 Feb 5.
- 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.
Margreet Wessels, MD, PhD principal investigator
Rijnstate Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Distress Syndrome and Pneumonia, run by Rijnstate Hospital.
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 1 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 19 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mendel Ottow, Drs, MD (+31880058888, mottow@rijnstate.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Discharge or admitted? (time frame: within 30-60 minutes after inclusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04168554, which also lists 1 linked publication.
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 Nov 2019.