Pediatric Acute Respiratory Distress SyndromeNCT06684119
Pediatric Positive End Expiratory Pressure (PEEP) Titration Using Electrical Impedence Tomography (EIT)
A study testing Electrical Impedance Tomography positive end-expiratory pressure titration in people with Pediatric Acute Respiratory Distress Syndrome, run by Children's Hospital Los Angeles at 1 site in United States.
Trial summary
The goal of this clinical trial is to perform a PEEP titration protocol and use EIT to identify the optimal PEEP at which lung overdistention and collapse are most effectively balanced. Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- Pediatric Acute Respiratory Distress Syndrome
- What is being tested?
- Electrical Impedance Tomography positive end-expiratory pressure titration
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Dec 2024to 1 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 0 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Any person who is less than 18 years of age
- is on invasive mechanical ventilation
- is not spontaneously breathing
- meets PARDS criteria
Who cannot join
- Contraindication to the use of EIT
- Hemodynamic instability
- Contraindications to hypercapnia
- patients with uncuffed endotracheal or tracheostomy tubes
- diagnosis of pneumothorax or bronchopleural fistula
- non-conventional ventilation
Show all 11Show fewer
- any patient on extra-corporeal membrane oxygenation (ECMO) support
- less than 1 week post-operatively from cardiac surgery
- the following cardiac diagnoses: Glenn or Fontan physiology, significant right to left shunt
- Corrected Gestational Age < 37 weeks
- pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Children's Hospital Los Angeles
Los Angeles, California, 90027
Hayden Leeds
About this study
Official title: Assessing Optimal Positive End-expiratory Pressure (PEEP) Using Electrical Impedance Tomography (EIT) During a PEEP Titration Protocol in Mechanically Ventilated Children with Pediatric Acute Respiratory Distress Syndrome (PARDS)
The goal of this clinical trial is to perform a PEEP titration protocol and use EIT to identify the optimal PEEP at which lung overdistention and collapse are most effectively balanced. The primary and secondary aims of the study are as follows:
Identify the difference between the optimal PEEP recommended by EIT metrics and the current guideline recommended approach to identifying optimal PEEP in PARDS. There will be a statistically significant difference in the recommended optimal PEEP identified using the EIT PEEP titration tool and that of the PEEP/FiO2 grid recommendations.
Read more
Determine the difference in physiologic metrics between EIT optimal PEEP and the PEEP/FiO2 recommended PEEP.
Participants will undergoing EIT monitoring while being subjected to PEEP titration protocol.
- Being tested
- Electrical Impedance Tomography positive end-expiratory pressure titration
- Keywords
- positive end-expiratory pressure, Electrical Impedance Tomography, respiratory distress
- Medical subject headings
- Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical Impedance Tomography positive end-expiratory pressure titrationDevice
A PEEP titration will occur for the patient with the PEEP increased by 2 cm H2O every 2 minutes until a maximum PEEP of 20 or three steps (+ 6 cm H2O) above the set clinical PEEP. The PEEP will then be decreased by 2 cmH2O every 2 minutes until a minimum PEEP of 6 cmH2O or three steps (- 6 cm H2O) below their clinical PEEP.
| Study group | Role | What they receive |
|---|---|---|
| Electrical Impedance Tomography positive end-expiratory pressure | Experimental | Patients will be monitored using Electrical Impedance Tomography and the positive end-expiratory pressure titration tool as their positive end-expiratory pressure is adjusted according to a step wise positive end-expiratory pressure titration protocol. Receives: Device: Electrical Impedance Tomography positive end-expiratory pressure titration |
What is being measured
The primary outcome is the main question the study is designed to answer.
The absolute difference between the electrical impedence tomography (EIT) recommended PEEP and the PEEP recommended by the PEEP/fraction of inspired oxygen (FiO2) grid.
Collected using electrical impedence tomography (EIT). The EIT device provides the percentages of alveolar overdistention and collapse at each PEEP level. The best PEEP by EIT is defined as the PEEP level above the intersection of curves representing relative alveolar overdistention and collapse.
Measured: Day 1
Secondary outcomes (7)
Lung recruitability, as measured by electrical impedence tomography, and its association with difference in optimal PEEP recommended by electrical impedence tomography versus the PEEP/FiO2 grid
Recruitability will be defined as the absolute reduction in the percentage of collapse when comparing the highest and lowest PEEP achieved, as measured by electrical impedence tomography.
Measured: Day 1
Difference in systolic impendence, as a surrogate for cardiac output, using electrical impedence tomography at various PEEP levels
Using the electrical impedence tomography pulsatility filter/tool, a difference in systolic impendence, attributed to the cardiac cycle, can be calculated. This will be used as a surrogate for stroke volume and will be compared across PEEP levels.
Measured: Day 1
Change in static compliance across different PEEP levels during a PEEP titration
Static compliance is defined as the change in volume divided by the change in pressure during an inspiratory hold (when airflow is zero). It reflects the elastic properties of the lung and chest wall.
Measured: Day 1
Change in driving pressure across different PEEP levels during a PEEP titration
Driving pressure is the difference between the plateau pressure (the pressure measured during an inspiratory hold, when airflow is zero) and the positive end-expiratory pressure (PEEP). It represents the pressure that actually distends the alveoli during mechanical ventilation.
Measured: Day 1
Change in plateau pressure across different PEEP levels during a PEEP titration
Plateau pressure is the pressure measured during an inspiratory hold maneuver, which occurs when the ventilator temporarily halts airflow at the end of the inspiratory phase. This allows the pressure in the alveoli to stabilize, providing a true reflection of the pressure needed to distend the lungs, without the effects of airflow resistance.
Measured: Day 1
Change in dead space, as measured by volumetric capnography, across different PEEP levels during a PEEP titration
For patients who consent to the optional placement of a volumetric capnography device, dead space will be continuously measured using volumetric capnography by measuring the volume of carbon dioxide (CO2) exhaled with each breath (VeCO2) and calculating the CO2 ventilatory equivalent (minute ventilation/VCO2). Airway dead space can be obtained with each breath.
Measured: Day 1
Change in transplural pressure, as measured by esophageal manometry, across different PEEP levels during a PEEP titration
For patients who consent to the optional component of having an esophageal balloon catheter placed, esophageal manometry will be used to measure transplural pressure. The difference between the pressure in the alveoli (intrapulmonary pressure) and the pressure in the pleural space (intrapleural pressure). It reflects the pressure required to expand the lungs and is crucial for understanding lung mechanics. This will be obtained using esophageal manometry with inspiratory and expiratory holds at each PEEP titration level.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start10 Dec 2024
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by Children's Hospital Los AngelesThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anoopindar Bhalla, Children's Hospital Los Angeles
- Investigators
- Anoopindar Bhalla, MD, Study director, Children's Hospital Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06684119
- Sponsor's protocol ID
- CHLA-24-00295
- Status last verified
- Dec 2024
- First submitted
- 8 Nov 2024
- Last updated
- 7 Feb 2025
- 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 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Optimal Positive End-expiratory Pressure (PEEP) Using Electrical Impedance Tomography (EIT) During a PEEP Titration Protocol in Mechanically Ventilated Children with Pediatric Acute Respiratory Distress Syndrome (PARDS)
- ClinicalTrials.gov ID
- NCT06684119
- Acronym / sponsor ID
- CHLA-24-00295
- Keywords
- positive end-expiratory pressure, Electrical Impedance Tomography, respiratory distress
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Children's Hospital Los AngelesUniversity, hospital or other
- Study start
- 10 Dec 2024 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 12 Nov 2024 (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 goal of this clinical trial is to perform a PEEP titration protocol and use EIT to identify the optimal PEEP at which lung overdistention and collapse are most effectively balanced. The primary and secondary aims of the study are as follows:
Identify the difference between the optimal PEEP recommended by EIT metrics and the current guideline recommended approach to identifying optimal PEEP in PARDS. There will be a statistically significant difference in the recommended optimal PEEP identified using the EIT PEEP titration tool and that of the PEEP/FiO2 grid recommendations.
Determine the difference in physiologic metrics between EIT optimal PEEP and the PEEP/FiO2 recommended PEEP.
Participants will undergoing EIT monitoring while being subjected to PEEP titration protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Electrical Impedance Tomography positive end-expiratory pressure | Experimental | Device: Electrical Impedance Tomography positive end-expiratory pressure titrationPatients will be monitored using Electrical Impedance Tomography and the positive end-expiratory pressure titration tool as their positive end-expiratory pressure is adjusted according to a step wise positive end-expiratory pressure titration protocol. |
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Any person who is less than 18 years of age
- is on invasive mechanical ventilation
- is not spontaneously breathing
- meets PARDS criteria
Key exclusion criteria (11 listed)
- Contraindication to the use of EIT
- Hemodynamic instability
- Contraindications to hypercapnia
- patients with uncuffed endotracheal or tracheostomy tubes
- diagnosis of pneumothorax or bronchopleural fistula
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 |
|---|---|---|
| Electrical Impedance Tomography positive end-expiratory pressure titrationA PEEP titration will occur for the patient with the PEEP increased by 2 cm H2O every 2 minutes until a maximum PEEP of 20 or three steps (+ 6 cm H2O) above the set clinical PEEP. The PEEP will then be decreased by 2 cmH2O every 2 minutes until a minimum PEEP of 6 cmH2O or three steps (- 6 cm H2O) below their clinical PEEP. | Device | Electrical Impedance Tomography positive end-expiratory pressure |
Primary outcome
The absolute difference between the electrical impedence tomography (EIT) recommended PEEP and the PEEP recommended by the PEEP/fraction of inspired oxygen (FiO2) grid.
Time frame: Day 1
Collected using electrical impedence tomography (EIT). The EIT device provides the percentages of alveolar overdistention and collapse at each PEEP level. The best PEEP by EIT is defined as the PEEP level above the intersection of curves representing relative alveolar overdistention and collapse.
7 secondary outcomes
Lung recruitability, as measured by electrical impedence tomography, and its association with difference in optimal PEEP recommended by electrical impedence tomography versus the PEEP/FiO2 grid
Time frame: Day 1
Difference in systolic impendence, as a surrogate for cardiac output, using electrical impedence tomography at various PEEP levels
Time frame: Day 1
Change in static compliance across different PEEP levels during a PEEP titration
Time frame: Day 1
Change in driving pressure across different PEEP levels during a PEEP titration
Time frame: Day 1
Change in plateau pressure across different PEEP levels during a PEEP titration
Time frame: Day 1
Change in dead space, as measured by volumetric capnography, across different PEEP levels during a PEEP titration
Time frame: Day 1
Change in transplural pressure, as measured by esophageal manometry, across different PEEP levels during a PEEP titration
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
- Individual participant dataSharing planned: No
Related trials for Pediatric Acute Respiratory Distress Syndrome
RecruitingObservational study
Role of Dyspnea in the Progression of Pediatric Acute Respiratory Distress Syndrome
Pediatric Acute Respiratory Distress Syndrome (PARDS)
Not yet recruiting
AI-Guided Mechanical Ventilation in Children: A Randomized Controlled Trial
Acute Respiratory Distress Syndrome, Pneumonia in Children
Active, not recruitingObservational study
ARDS in Children and ECMO Initiation Strategies Impact on Neurodevelopment (ASCEND)
Acute Respiratory Distress Syndrome, Extracorporeal Membrane Oxygenation
RecruitingObservational study
Altitude and Outcomes in Pediatric ARDS: A Multicenter Study
Respiratory Distress Syndrome, Pediatric, Altitude Hypoxia
Active, not recruiting
PROSpect: Prone and Oscillation Pediatric Clinical Trial
Acute Respiratory Distress Syndrome in Children
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.
Anoopindar Bhalla, MD study director
Children's Hospital Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrical Impedance Tomography positive end-expiratory pressure titration in people with Pediatric Acute Respiratory Distress Syndrome, run by Children's Hospital Los Angeles 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 4 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 7 Feb 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hayden Leeds, MD (3233617939, hleeds@chla.usc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The absolute difference between the electrical impedence tomography (EIT) recommended PEEP and the PEEP recommended by the PEEP/fraction of inspired oxygen (FiO2) grid. (time frame: Day 1). 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 7 Feb 2025.