Acute Respiratory FailurePELUCHE 2NCT07532811
Evaluation of Perfusion and Ventilation Distribution in Children: a Pilot Study.
A study testing Evaluation of perfusion with Electrical impedance tomography using sodium chloride or sodium bicarbonate in people with Acute Respiratory Failure, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Electrical impedance tomography (EIT) is a recent monitoring technique that provides information on regional ventilation distribution. Following the injection of a hypertonic saline bolus, EIT can also assess regional pulmonary perfusion distribution, allowing evaluation of the ventilation/perfusion (V/Q) ratio. Read more about this study
- Who is it for?
- Ages Up to 12 years
- Conditions the study is for
- Acute Respiratory Failure
- What is being tested?
- Evaluation of perfusion with Electrical impedance tomography using sodium chloride or sodium bicarbonate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 13 May 2026to 13 Aug 2028
- 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 Up to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- patients < 12 years hospitalized in pediatric intensive care
- intubated, under conventional invasive mechanical ventilation and sedated
- between 3 and 40 kg
- with central venous access in the superior vena cava
- consent signed by parents or legal guardians
Who cannot join
- Patients with significant leaks > 20% around the endotracheal tube
- Patients receiving spontaneous ventilation (inspiratory support, NIV, etc.)
- Natremia > 150 mmol/L at inclusion
- Hyperchloremia ≥ 115 mmol/L and/or hypokaliema ≤ 3 mmol/L
- Patients with intracranial hypertension
- Patients with active bleeding or persistent hemodynamic instability despite amines
Show all 11Show fewer
- Patients with heart failure, uncorrected cyanotic heart disease, or a history of cardiac arrhythmia
- Patients with contraindications to the use of the electrical impedance pulmonary tomography belt (skin lesions, burns, or recent thoracic surgery)
- Conditions in which EIT data acquisition will be disrupted (chest dressings, pneumothorax, ECMO)
- Patients with severe hypoxemia defined as FiO2 > 90% to maintain SpO2 > 88%
- Individuals not affiliated with a social security system or beneficiaries of a similar system
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Florent BAUDIN
Bron, France, 69500
Florent BAUDIN, MD
About this study
Official title: Feasibility Study of the Evaluation of Perfusion and Ventilation Distribution in Children : a Pilot Study
Electrical impedance tomography (EIT) is a recent monitoring technique that provides information on regional ventilation distribution. Following the injection of a hypertonic saline bolus, EIT can also assess regional pulmonary perfusion distribution, allowing evaluation of the ventilation/perfusion (V/Q) ratio.
In adults, protocols for assessing perfusion distribution require the injection of 10 mL of a 7.5% or 10% NaCl solution or sodium bicarbonate over a few seconds. Studies have reported good hemodynamic tolerance, adequate image quality, and no significant changes in serum sodium levels. However, this volume and sodium load are not appropriate for small children.
To date, no pediatric protocol exists for assessing pulmonary perfusion distribution and the ventilation/perfusion ratio using EIT. It is therefore proposed to conduct a pilot study to evaluate the feasibility of assessing pulmonary perfusion by EIT using a weight-adjusted bolus of hypertonic saline (NaCl or sodium bicarbonate).
- Conditions
- Acute Respiratory Failure
- Being tested
- Evaluation of perfusion with Electrical impedance tomography using sodium chloride or sodium bicarbonate
- Keywords
- Electrical impedance tomography, Pediatric intensive care unit, Perfusion and ventilation distribution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of perfusion with Electrical impedance tomography using sodium chloride or sodium bicarbonateOther
All patients will undergo EIT monitoring (Enlight 2100, Timpel, Brazil) using a belt adjusted to the thoracic circumference. Ventilation distribution will be assessed with a tidal volume of 8 mL/kg.
Following a breath hold, a saline solution (sodium chloride or sodium bicarbonate) will be injected over a few seconds. Perfusion distribution, as well as impedance signal variation, will be recorded using dedicated software (Timpel, Brazil).
Data acquisition will be considered valid if the impedance signal variation induced by the saline solution injection is at least equivalent to the amplitude variation observed during ventilation with a tidal volume of 8 mL/kg.
2 measurements at 4 to 6-hours intervals with volume or concentration adjustment after the first injection if needed in the group 1
| Study group | Role | What they receive |
|---|---|---|
| Sodium chloride (NaCl) | Experimental | The first 12 patients will be included in this group, with at least 6 patients weighing less than 20 kg.
After a breath hold, a saline solution (NaCl 5% at 0.3 mL/kg; maximum 10 mL) will be injected over a few seconds with EIT acquisition.
After 4 to 6 hours, a second acquisition will be performed using the same volume and concentration if the signal is correct. If the signal is insufficient, the injected volume will be increased to 0.5 mL/kg in children weighing less than 20 kg, and the saline concentration will be increased to 7.5% in children weighing more than 20 kg. Receives: Other: Evaluation of perfusion with Electrical impedance tomography using sodium chloride or sodium bicarbonate |
| Sodium bicarbonate | Experimental | The last 8 patients will be included in this group, with at least 4 patients weighing less than 20 kg.
After a breath hold, a saline bicarbonate solution (4.2%, 0.5 mL/kg; maximum 10 mL) will be injected over a few seconds with EIT acquisition.
After 4 to 6 hours, a second acquisition will be performed using the same volume and concentration (no volume or concentration adjustment will be made in this group). Receives: Other: Evaluation of perfusion with Electrical impedance tomography using sodium chloride or sodium bicarbonate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with pulmonary perfusion acquisition consider as valid
Data acquisition will be considered valid if the impedance signal variation induced by the saline solution injection is at least equivalent to the amplitude variation observed during ventilation with a tidal volume of 8 mL/kg.
Measured: Hour 0 ; Between Hour 4 and Hour 6
Secondary outcomes (8)
Proportion of patients requiring an increase in volume and/or concentration of saline solution
Increase in the volume and/or concentration of the saline solution due to insufficient signal detection during the first injection (Group 1).
Measured: Between Hour 4 and Hour 6
Proportion of respiratory acquisition failures explained by breathing movements
Data acquisition failure related to variations in the airway pressure waveform recorded by the software.
Measured: Hour 0 ; Between Hour 4 and Hour 6
Distribution of pulmonary perfusion
Description of the distribution of regional pulmonary perfusion in children, expressed as percentages across predefined regions of interest (right versus left and anterior versus posterior).
Measured: Hour 0 ; Between Hour 4 and Hour 6
Natremia variation after injection
Serum sodium concentration (mmol/L) measured before and after injection, with calculation of absolute (mmol/L) and relative (%) changes.
Measured: Hour 0 ; Hour 1 ; Between Hour 5 and Hour 7
Natremia variation at day one
Serum sodium concentration (mmol/L) measured at baseline and on day 1, with calculation of absolute (mmol/L) and relative (%) changes from baseline.
Measured: Hour 0 ; Hour 24
Heart rate variation
Heart rate (beats/min) measured before and after saline solution injection, with calculation of absolute (beats/min) and relative (%) changes
Measured: Hour 0 ; Hour 1 ; Between Hour 5 and Hour 7
Blood pressure variation
Systolic, diastolic, and mean arterial blood pressure measured before and after saline solution injection, with calculation of absolute (mmHg) and relative (%) changes.
Measured: Hour 0 ; Hour 1 ; Between Hour 5 and Hour 7
Significant hemodynamic events
Any change in heart rate or systolic blood pressure > 15% from baseline
Measured: Through study completion, an average of 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start13 May 2026
- Primary completion13 May 2028 (estimated)
- Study completion13 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory FailureStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Non-randomised
- Intervention model
- Sequential
- Model description
- Model Description
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07532811
- Sponsor's protocol ID
- 69HCL25_0492
- Other IDs
- 2025-A02466-43
- Acronym
- PELUCHE 2
- Status last verified
- May 2026
- First submitted
- 18 Mar 2026
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of the Evaluation of Perfusion and Ventilation Distribution in Children : a Pilot Study
- ClinicalTrials.gov ID
- NCT07532811
- Acronym / sponsor ID
- PELUCHE 2 / 69HCL25_0492
- Conditions
- Acute Respiratory Failure
- Keywords
- Electrical impedance tomography, Pediatric intensive care unit, Perfusion and ventilation distribution
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 13 May 2026 (actual)
- Primary completion
- 13 May 2028 (estimated)
- Study completion
- 13 Aug 2028 (estimated)
- First posted
- 16 Apr 2026 (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.
Electrical impedance tomography (EIT) is a recent monitoring technique that provides information on regional ventilation distribution. Following the injection of a hypertonic saline bolus, EIT can also assess regional pulmonary perfusion distribution, allowing evaluation of the ventilation/perfusion (V/Q) ratio.
In adults, protocols for assessing perfusion distribution require the injection of 10 mL of a 7.5% or 10% NaCl solution or sodium bicarbonate over a few seconds. Studies have reported good hemodynamic tolerance, adequate image quality, and no significant changes in serum sodium levels. However, this volume and sodium load are not appropriate for small children.
To date, no pediatric protocol exists for assessing pulmonary perfusion distribution and the ventilation/perfusion ratio using EIT. It is therefore proposed to conduct a pilot study to evaluate the feasibility of assessing pulmonary perfusion by EIT using a weight-adjusted bolus of hypertonic saline (NaCl or sodium bicarbonate).
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Model Description
| Arm | Type | Receives |
|---|---|---|
| Sodium chloride (NaCl) | Experimental | Other: Evaluation of perfusion with Electrical impedance tomography using sodium chloride or sodium bicarbonateThe first 12 patients will be included in this group, with at least 6 patients weighing less than 20 kg. After a breath hold, a saline solution (NaCl 5% at 0.3 mL/kg; maximum 10 mL) will be injected over a few seconds with EIT acquisition. After 4 to 6 hours, a second acquisition will be performed using the same volume and concentration if the signal is correct. If the signal is insufficient, the injected volume will be increased to 0.5 mL/kg in children weighing less than 20 kg, and the saline concentration will be increased to 7.5% in children weighing more than 20 kg. |
| Sodium bicarbonate | Experimental | Other: Evaluation of perfusion with Electrical impedance tomography using sodium chloride or sodium bicarbonateThe last 8 patients will be included in this group, with at least 4 patients weighing less than 20 kg. After a breath hold, a saline bicarbonate solution (4.2%, 0.5 mL/kg; maximum 10 mL) will be injected over a few seconds with EIT acquisition. After 4 to 6 hours, a second acquisition will be performed using the same volume and concentration (no volume or concentration adjustment will be made in this group). |
Who may qualify
- Ages
- Up to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- patients < 12 years hospitalized in pediatric intensive care
- intubated, under conventional invasive mechanical ventilation and sedated
- between 3 and 40 kg
- with central venous access in the superior vena cava
- consent signed by parents or legal guardians
Key exclusion criteria (11 listed)
- Patients with significant leaks > 20% around the endotracheal tube
- Patients receiving spontaneous ventilation (inspiratory support, NIV, etc.)
- Natremia > 150 mmol/L at inclusion
- Hyperchloremia ≥ 115 mmol/L and/or hypokaliema ≤ 3 mmol/L
- Patients with intracranial hypertension
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 |
|---|---|---|
| Evaluation of perfusion with Electrical impedance tomography using sodium chloride or sodium bicarbonateAll patients will undergo EIT monitoring (Enlight 2100, Timpel, Brazil) using a belt adjusted to the thoracic circumference. Ventilation distribution will be assessed with a tidal volume of 8 mL/kg. Following a breath hold, a saline solution (sodium chloride or sodium bicarbonate) will be injected over a few seconds. Perfusion distribution, as well as impedance signal variation, will be recorded using dedicated software (Timpel, Brazil). Data acquisition will be considered valid if the impedance signal variation induced by the saline solution injection is at least equivalent to the amplitude variation observed during ventilation with a tidal volume of 8 mL/kg. 2 measurements at 4 to 6-hours intervals with volume or concentration adjustment after the first injection if needed in the group 1 | Other | Sodium bicarbonate, Sodium chloride (NaCl) |
Primary outcome
Proportion of patients with pulmonary perfusion acquisition consider as valid
Time frame: Hour 0 ; Between Hour 4 and Hour 6
Data acquisition will be considered valid if the impedance signal variation induced by the saline solution injection is at least equivalent to the amplitude variation observed during ventilation with a tidal volume of 8 mL/kg.
8 secondary outcomes
Proportion of patients requiring an increase in volume and/or concentration of saline solution
Time frame: Between Hour 4 and Hour 6
Proportion of respiratory acquisition failures explained by breathing movements
Time frame: Hour 0 ; Between Hour 4 and Hour 6
Distribution of pulmonary perfusion
Time frame: Hour 0 ; Between Hour 4 and Hour 6
Natremia variation after injection
Time frame: Hour 0 ; Hour 1 ; Between Hour 5 and Hour 7
Natremia variation at day one
Time frame: Hour 0 ; Hour 24
Heart rate variation
Time frame: Hour 0 ; Hour 1 ; Between Hour 5 and Hour 7
Blood pressure variation
Time frame: Hour 0 ; Hour 1 ; Between Hour 5 and Hour 7
Significant hemodynamic events
Time frame: Through study completion, an average of 24 hours
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 19 May 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Evaluation of perfusion with Electrical impedance tomography using sodium chloride or sodium bicarbonate in people with Acute Respiratory Failure, run by Hospices Civils de Lyon at 1 site in France.
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 5 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 19 May 2026. 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 France. 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 Florent BAUDIN, Pr (04 72 12 97 05, florent.baudin@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with pulmonary perfusion acquisition consider as valid (time frame: Hour 0 ; Between Hour 4 and Hour 6). 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 May 2026.