[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100633909":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":23,"centralContacts":24,"locations":30,"responsibleParty":48,"collaborators":23,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":52,"sex":58,"minAge":23,"maxAge":59,"enrollmentInfo":60,"targetDuration":23,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":69,"overallStatus":33,"whyStopped":23,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"Hospices Civils de Lyon","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Sodium chloride (NaCl)","EXPERIMENTAL","The first 12 patients will be included in this group, with at least 6 patients weighing less than 20 kg.\n\nAfter a breath hold, a saline solution (NaCl 5% at 0.3 mL\u002Fkg; maximum 10 mL) will be injected over a few seconds with EIT acquisition.\n\nAfter 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\u002Fkg in children weighing less than 20 kg, and the saline concentration will be increased to 7.5% in children weighing more than 20 kg.",[13],"Other: Evaluation of perfusion with Electrical impedance tomography using sodium chloride or sodium bicarbonate",{"label":15,"type":10,"description":16,"interventionNames":17},"Sodium bicarbonate","The last 8 patients will be included in this group, with at least 4 patients weighing less than 20 kg.\n\nAfter a breath hold, a saline bicarbonate solution (4.2%, 0.5 mL\u002Fkg; maximum 10 mL) will be injected over a few seconds with EIT acquisition.\n\nAfter 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).",[13],[19],{"type":6,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"Evaluation of perfusion with Electrical impedance tomography using sodium chloride or sodium bicarbonate","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\u002Fkg.\n\nFollowing 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).\n\nData 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\u002Fkg.\n\n2 measurements at 4 to 6-hours intervals with volume or concentration adjustment after the first injection if needed in the group 1",[15,9],null,[25],{"name":26,"role":27,"phone":28,"phoneExt":23,"email":29},"Florent BAUDIN, Pr","CONTACT","04 72 12 97 05","florent.baudin@chu-lyon.fr",[31],{"facility":32,"status":33,"city":34,"state":35,"zip":36,"country":35,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Florent BAUDIN","RECRUITING","Bron","France","69500","FR",{"type":39,"coordinates":40},"Point",[41,42],4.91303,45.73865,{"lat":42,"lon":41},[45],{"name":46,"role":47,"phone":23,"phoneExt":23,"email":23},"Florent BAUDIN, MD","PRINCIPAL_INVESTIGATOR",{"type":49,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR","100633909","evaluation-of-perfusion-and-ventilation-distribution-in-children-a-pilot-study-100633909",false,"NCT07532811","Evaluation of Perfusion and Ventilation Distribution in Children: a Pilot Study.","Feasibility Study of the Evaluation of Perfusion and Ventilation Distribution in Children : a Pilot Study","PELUCHE 2","Inclusion Criteria:\n\n* patients \\\u003C 12 years hospitalized in pediatric intensive care\n* intubated, under conventional invasive mechanical ventilation and sedated\n* between 3 and 40 kg\n* with central venous access in the superior vena cava\n* consent signed by parents or legal guardians\n\nExclusion Criteria:\n\n* Patients with significant leaks \\> 20% around the endotracheal tube\n* Patients receiving spontaneous ventilation (inspiratory support, NIV, etc.)\n* Natremia \\> 150 mmol\u002FL at inclusion\n* Hyperchloremia ≥ 115 mmol\u002FL and\u002For hypokaliema ≤ 3 mmol\u002FL\n* Patients with intracranial hypertension\n* Patients with active bleeding or persistent hemodynamic instability despite amines\n* Patients with heart failure, uncorrected cyanotic heart disease, or a history of cardiac arrhythmia\n* Patients with contraindications to the use of the electrical impedance pulmonary tomography belt (skin lesions, burns, or recent thoracic surgery)\n* Conditions in which EIT data acquisition will be disrupted (chest dressings, pneumothorax, ECMO)\n* Patients with severe hypoxemia defined as FiO2 \\> 90% to maintain SpO2 \\> 88%\n* Individuals not affiliated with a social security system or beneficiaries of a similar system","ALL","12 Years",{"count":61,"type":62},20,"ESTIMATED","INTERVENTIONAL",[65],"NA","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\u002Fperfusion (V\u002FQ) ratio.\n\nIn 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.\n\nTo date, no pediatric protocol exists for assessing pulmonary perfusion distribution and the ventilation\u002Fperfusion 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).",[68],"Acute Respiratory Failure",[70,71,72],"Electrical impedance tomography","Pediatric intensive care unit","Perfusion and ventilation distribution","2026-05-15",{"date":75,"type":76},"2026-05-19","ACTUAL",{"date":78,"type":76},"2026-05-13",{"date":80,"type":62},"2028-08-13",{"name":5,"class":6},1]