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Official title Evaluation of Perfusion and Ventilation Distribution in Children: a Pilot Study.
ClinicalTrials.gov ID: NCT07532811
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages up to 12
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Bron, France, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, up to 12 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bron, France, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.