ExtubationNCT05098834
Electrical Impedence Tomography With ENLIGHT2100
A study testing ENLIGHT 2100 ventilatory electrical impedance tomograph in people with Extubation, run by Duke University at 1 site in United States.
Trial summary
Children with acute respiratory failure often need a breathing tube attached to a breathing machine, called a mechanical ventilator, to assist their breathing until they can recover. Once the cause of respiratory failure has resolved or improved enough, the breathing tube can be removed, and that is called extubation. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Extubation
- What is being tested?
- ENLIGHT 2100 ventilatory electrical impedance tomograph
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2024to Jan 2025
- 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 less than 17 years of age admitted to the Duke Children's PICU or PCICU with acute respiratory failure due to a pulmonary illness will be considered eligible for the study
Who cannot join
- Patients with corrected gestational age less than 37 weeks
- Patients with contraindications to the ENLIGHT device (i.e. temporary or permanent pacemaker, vagal nerve stimulator, automatic implanted defibrillator, chest tubes that interfere with electrode belt placement, open chest wounds, unstable thorax, severe chest wall deformities)
- known pregnancy
- Patients previously enrolled in this study will be excluded from participation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Lung Volumes During Liberation From Mechanical Ventilation Using Electrical Impedance Tomography in Children
Children with acute respiratory failure often need a breathing tube attached to a breathing machine, called a mechanical ventilator, to assist their breathing until they can recover. Once the cause of respiratory failure has resolved or improved enough, the breathing tube can be removed, and that is called extubation. The Extubation Readiness Test (ERT) is a simple evaluation commonly performed in the intensive care unit to determine if a child is ready to have the breathing tube removed.
The purpose of this study is to better understand how the ERT and the eventual removal of the breathing tube affect where the air is in the lungs, and whether this can help predict which children will succeed or fail having the breathing tube taken out. This can done be at the bedside with a device called electrical impedance tomograph. This novel device is painless and uses a belt fitted with sensors placed around the chest to show where the air is in the lungs.
- Conditions
- Extubation
- Being tested
- ENLIGHT 2100 ventilatory electrical impedance tomograph
- Keywords
- Acute respiratory failure, Breathing tube, Mechanical ventilator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ENLIGHT 2100 ventilatory electrical impedance tomographDevice
The ENLIGHT 2100 system will remain connected to the patient for data acquisition from immediately prior to initiation of the ERT until up to 24 hours following extubation.
| Study group | Role | What they receive |
|---|---|---|
| PICU and PCICU Patients | Experimental | Patients younger than 17 years of age receiving mechanical ventilation for an acute respiratory illness will be approached to participate prior to initiation of an ERT for clinical purposes. Receives: Device: ENLIGHT 2100 ventilatory electrical impedance tomograph |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in expiratory lung volume as measured by global lung electrical impedance
Measured: Baseline, 60 mins, 75 mins, 90 mins
Secondary outcomes (3)
Change in regional ventilation (Anterior/Posterior) distribution as measured by regional electrical impedance
Measured: Baseline, 60 mins, 75 mins, 90 mins
Change in regional ventilation (Right/Left) distribution as measured by regional electrical impedance
Measured: Baseline, 60 mins, 75 mins, 90 mins
Percent of failed extubation as measured by need for re-intubation
Measured: Within 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2021
- Study startAug 2024 (estimated)
- Primary completionJan 2025 (estimated)
- Study completionJan 2025 (estimated)
Why it stopped: Device received FDA approval
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ExtubationStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexandre Rotta, MD, FCCM, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05098834
- Sponsor's protocol ID
- Pro00108931
- Status last verified
- Jun 2024
- First submitted
- 18 Oct 2021
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Lung Volumes During Liberation From Mechanical Ventilation Using Electrical Impedance Tomography in Children
- ClinicalTrials.gov ID
- NCT05098834
- Acronym / sponsor ID
- Pro00108931
- Conditions
- Extubation
- Keywords
- Acute respiratory failure, Breathing tube, Mechanical ventilator
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Device received FDA approval
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Aug 2024 (estimated)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 28 Oct 2021 (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.
Children with acute respiratory failure often need a breathing tube attached to a breathing machine, called a mechanical ventilator, to assist their breathing until they can recover. Once the cause of respiratory failure has resolved or improved enough, the breathing tube can be removed, and that is called extubation. The Extubation Readiness Test (ERT) is a simple evaluation commonly performed in the intensive care unit to determine if a child is ready to have the breathing tube removed.
The purpose of this study is to better understand how the ERT and the eventual removal of the breathing tube affect where the air is in the lungs, and whether this can help predict which children will succeed or fail having the breathing tube taken out. This can done be at the bedside with a device called electrical impedance tomograph. This novel device is painless and uses a belt fitted with sensors placed around the chest to show where the air is in the lungs.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PICU and PCICU Patients | Experimental | Device: ENLIGHT 2100 ventilatory electrical impedance tomographPatients younger than 17 years of age receiving mechanical ventilation for an acute respiratory illness will be approached to participate prior to initiation of an ERT for clinical purposes. |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Patients less than 17 years of age admitted to the Duke Children's PICU or PCICU with acute respiratory failure due to a pulmonary illness will be considered eligible for the study
Key exclusion criteria (4 listed)
- Patients with corrected gestational age less than 37 weeks
- Patients with contraindications to the ENLIGHT device (i.e. temporary or permanent pacemaker, vagal nerve stimulator, automatic implanted defibrillator, chest tubes that interfere with electrode belt placement, open chest wounds, unstable thorax, severe chest wall deformities)
- known pregnancy
- Patients previously enrolled in this study will be excluded from participation.
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 |
|---|---|---|
| ENLIGHT 2100 ventilatory electrical impedance tomographThe ENLIGHT 2100 system will remain connected to the patient for data acquisition from immediately prior to initiation of the ERT until up to 24 hours following extubation. | Device | PICU and PCICU Patients |
Primary outcome
Change in expiratory lung volume as measured by global lung electrical impedance
Time frame: Baseline, 60 mins, 75 mins, 90 mins
3 secondary outcomes
Change in regional ventilation (Anterior/Posterior) distribution as measured by regional electrical impedance
Time frame: Baseline, 60 mins, 75 mins, 90 mins
Change in regional ventilation (Right/Left) distribution as measured by regional electrical impedance
Time frame: Baseline, 60 mins, 75 mins, 90 mins
Percent of failed extubation as measured by need for re-intubation
Time frame: Within 24 hours
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 19 Sep 2024.
- 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.
Alexandre Rotta, MD, FCCM principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ENLIGHT 2100 ventilatory electrical impedance tomograph in people with Extubation, run by Duke University at 1 site 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 1 inclusion and 4 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
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?
Change in expiratory lung volume as measured by global lung electrical impedance (time frame: Baseline, 60 mins, 75 mins, 90 mins). 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 Sep 2024.