Evaluation of Perfusion and Ventilation Distribution in Children: a Pilot Study. (NCT07532811) | Clinical Trial Compass
RecruitingNot Applicable
Evaluation of Perfusion and Ventilation Distribution in Children: a Pilot Study.
France20 participantsStarted 2026-05-13
Plain-language 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.
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).
Who can participate
Age range
12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of patients with pulmonary perfusion acquisition consider as valid