protocolSection identificationModule nctId: NCT06262360, orgStudyIdInfo id: P2023457, briefTitle: Changes in Pulmonary Ventilation Distribution Assessed by Electrical Impedance Tomography in Healthy Children Under General Anesthesia, acronym: EIT_ped, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-16, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-09-30, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Queen Fabiola Children's University Hospital, class: OTHER, descriptionModule briefSummary: The incidence of atelectasis is high in patients undergoing general anesthesia. This may cause oxygenation impairment and further contribute to post-operative pulmonary complications. As important airway management devices for general anesthesia, few studies have compared the impact of laryngeal mask airway and spontaneous breathing on atelectasis. Through the study, the distribution of the pulmonary ventilation of children undergoing an elective and standard procedure in our center (H.U.D.E.R.F.) will be studied using electric impedance tomography.Children from 1 year-old to 6-year-old, ASA physical status I or II who will undergo elective circumcisions under general anesthesia associated with regional anesthesia (Penile Block10) at the One Day Clinic of H.U.D.E.R.F. (Hôpital des Enfants Reine Fabiola - Brussels - Belgium).Patients will be allocated to three different group in a ration of 1:1:1.* Group 1: spontaneous mask ventilation (20 patients).* Group 2: spontaneous laryngeal mask (LMA) ventilation (20 patients).* Group 3: spontaneous-pressure support LMA ventilation (LMA SV-PS) (20 patients).* Standard monitoring for the inductions of the anesthesia will include non-invasive blood pressure (NIBP), pulse oximetry (SpO2), Electrocardiogram (ECG), End-Tidal CO2 (EtCO2), End Tidal Sevoflurane concentration (EtSev %), inspired fraction of oxygen (FiO2), body temperature (rectal thermometer).Induction is based as well on the local routine protocols using an inhalation induction of the patient with Sevoflurane (Fet of 6-8%) and a recommended FiO2 from 80-90% maximum until the stabilization of the induction. Then the FiO2 will be decreased at least under 40% and Sevoflurane adapted to the need of the deepness of the anesthesia (both at the discretion of the anesthesiologist in charge of the patient).Depending on the randomization, the patient will undergo the surgery either with spontaneous face mask ventilation (group 1), LMA spontaneous ventilation (group 2), or LMA SV-PS (group 3) (during which the pressure support will be adapted at the discretion of the anesthesiologist but with a tidal volume included in the range of 6-10ml/kg).Electrical impedance tomography measurements:The effects of the spontaneous breathing (mask ventilation or LMA) or the pressure support ventilation (LMA SV-PS) on atelectasis formations and the distribution of the ventilation will be assessed using electrical impedance tomography.The device used during the study will be the "PulmoVista 500"; it will be provided by Dräger (Lübeck, Germany) free of charge and without any obligation or results/conclusions requested by Dräger. The device is approved CE (European regulation) and will be used in the conditions for which it has been designed.A reusable belt with 16 evenly spaced electrodes will be placed around the chest of each patient included in the study between the 4th and 6th ribs as recommended by Dräger.The EIT measurements will be taken of 4 different moments:T1: Before induction of the anesthesia in the preoperatory waiting room (and at least 30 min after the premedication).T2: After the induction of anesthesia (GA and penile block), just before the beginning of the surgical procedure.T3: After the end of the surgical procedure, just before discontinuing the general anesthesia.T4: Before the discharge of the PACU., conditionsModule conditions: Anesthesia, Pediatric, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: General anesthesia with mask ventilation, interventions name: General anesthesia and spontaneous laryngeal mask ventilation, interventions name: General anesthesia with spontaneous laryngeal mask ventilation with pressure support, outcomesModule primaryOutcomes measure: Variation of poorly ventilated pulmonary zones, eligibilityModule sex: ALL, minimumAge: 1 Year, maximumAge: 6 Years, stdAges: CHILD, contactsLocationsModule locations facility: H.U.B - Hôpital Universitaire des Enfants Reine Fabiola, status: RECRUITING, city: Brussels, zip: 1020, country: Belgium, contacts name: Denis Schmartz, MD, role: CONTACT, phone: +3225553919, email: denis.schmartz@hubruxelles.be, geoPoint lat: 50.85045, lon: 4.34878, hasResults: False