COVID 19NCT04519411
Transpulmonary Pressure Measurements in Intubated Children With Covid-19 Respiratory Failure
A study testing Transpulmonary pressure measurements in people with COVID 19, run by Mayo Clinic.
Trial summary
The purpose of this study is to gather information to help doctors understand how Covid-19 affects the lungs in children. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- COVID 19
- What is being tested?
- Transpulmonary pressure measurements
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 21 May 2020to Dec 2022
- Phase
- Interventional
- 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 Up to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients 0-17 years of age, 10 kg or greater, with suspected or confirmed Covid-19 respiratory failure requiring endotracheal intubation and mechanical ventilation admitted to Mayo Clinic Hospital, St. Mary's Campus Pediatric Intensive Care Unit.
Who cannot join
- Patients <10 kg
- Patients with pre-existing chronic mechanical ventilation (chronic respiratory failure)
- Patients with known esophageal disease (strictures, known esophageal anatomic abnormalities)
- Patients with severe coagulopathy (for which placement of esophageal balloon or other gastric tube via nose or mouth is contraindicated)
- Patients who are pregnant (as determined by standard pregnancy testing criteria for Pediatric ICU admission).
About this study
The purpose of this study is to gather information to help doctors understand how Covid-19 affects the lungs in children.
- Conditions
- COVID 19
- Being tested
- Transpulmonary pressure measurements
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transpulmonary pressure measurementsDiagnostic test
Transpulmonary pressure measurements
| Study group | Role | What they receive |
|---|---|---|
| Intubated pediatric patients with COVID-19 respiratory failure | Experimental | Not described Receives: Diagnostic Test: Transpulmonary pressure measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transpulmonary pressure
Numerical data
Measured: Through study complication, usually 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2020
- Study start21 May 2020
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Why it stopped: The study was stopped due to a very low rate of children with COVID-19 pneumonia that required endotracheal intubation, resulting in no eligible subjects to enroll.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID 19Studies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephen J. Gleich, Mayo Clinic
- Investigators
- Stephen J Gleich, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04519411
- Sponsor's protocol ID
- 20-003743
- Status last verified
- Feb 2023
- First submitted
- 18 Aug 2020
- Last updated
- 15 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transpulmonary Pressure Measurements in Intubated Children With Covid-19 Respiratory Failure
- ClinicalTrials.gov ID
- NCT04519411
- Acronym / sponsor ID
- 20-003743
- Conditions
- COVID 19
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was stopped due to a very low rate of children with COVID-19 pneumonia that required endotracheal intubation, resulting in no eligible subjects to enroll.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 21 May 2020 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 19 Aug 2020 (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.
The purpose of this study is to gather information to help doctors understand how Covid-19 affects the lungs in children.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intubated pediatric patients with COVID-19 respiratory failure | Experimental | Diagnostic Test: Transpulmonary pressure measurements |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Patients 0-17 years of age, 10 kg or greater, with suspected or confirmed Covid-19 respiratory failure requiring endotracheal intubation and mechanical ventilation admitted to Mayo Clinic Hospital, St. Mary's Campus Pediatric Intensive Care Unit.
Key exclusion criteria (5 listed)
- Patients <10 kg
- Patients with pre-existing chronic mechanical ventilation (chronic respiratory failure)
- Patients with known esophageal disease (strictures, known esophageal anatomic abnormalities)
- Patients with severe coagulopathy (for which placement of esophageal balloon or other gastric tube via nose or mouth is contraindicated)
- Patients who are pregnant (as determined by standard pregnancy testing criteria for Pediatric ICU admission).
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 |
|---|---|---|
| Transpulmonary pressure measurementsTranspulmonary pressure measurements | Diagnostic test | Intubated pediatric patients with COVID-19 respiratory failure |
Primary outcome
Transpulmonary pressure
Time frame: Through study complication, usually 2 weeks
Numerical data
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2023.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- 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.
Stephen J Gleich, MD principal investigator
Mayo Clinic
Questions about this trial
What is this clinical trial studying?
A study testing Transpulmonary pressure measurements in people with COVID 19, run by Mayo Clinic.
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 5 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: withdrawn, as of the sponsor's last update on 15 Feb 2023. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Transpulmonary pressure (time frame: Through study complication, usually 2 weeks). 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 15 Feb 2023; AzTrials last refreshed its copy on 8 Nov 2026.