NCT07532811 Evaluation of Perfusion and Ventilation Distribution in Children: a Pilot Study.
| NCT ID | NCT07532811 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospices Civils de Lyon |
| Condition | Acute Respiratory Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2026-05-13 |
| Primary Completion | 2028-05-13 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2026-05-13 with a primary completion date of 2028-05-13.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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).
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07532811 clinical trial?
This trial is open to participants of all sexes, up to 12 Years, studying Acute Respiratory Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07532811 currently recruiting?
Yes, NCT07532811 is actively recruiting participants. Contact the research team at florent.baudin@chu-lyon.fr for enrollment information.
Where is the NCT07532811 trial being conducted?
This trial is being conducted at Bron, France.
Who is sponsoring the NCT07532811 clinical trial?
NCT07532811 is sponsored by Hospices Civils de Lyon. The trial plans to enroll 20 participants.