An interventional study of General anesthesia with mask ventilation and General anesthesia and spontaneous laryngeal mask ventilation in Anesthesia, Pediatric, sponsored by Queen Fabiola Children's University Hospital. Recruiting at 1 site in Belgium. Open to participants aged 1 Year to 6 Years. Per ClinicalTrials.gov, last updated 2024-02-21.
Sponsored by Queen Fabiola Children's University Hospital · Not applicable, Interventional, and Basic science
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.
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.
Queen Fabiola Children's University Hospital is the lead sponsor of 28 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients under general anesthesia with spontaneous mask ventilation
Procedure: General anesthesia with mask ventilation
Patients under general anesthesia and spontaneous laryngeal mask ventilation
Procedure: General anesthesia and spontaneous laryngeal mask ventilation
Patients under general anesthesia with spontaneous laryngeal mask ventilation with pressure support
Procedure: General anesthesia with spontaneous laryngeal mask ventilation with pressure support
Randomization to General anesthesia with mask ventilation
Randomization to General anesthesia and spontaneous laryngeal mask ventilation
Randomization to General anesthesia with spontaneous laryngeal mask ventilation with pressure support
Variation of poorly ventilated pulmonary zones
Primary outcome will be the variation of poorly ventilated zones between period T1 (before induction of anesthesia) and period T2 (at the discharge from the PACU) that we may surrogate as atelectasis. The Pulmovista device divides the lungs in 4 areas (front to back in a supine patient) and the percentage of ventilation going to each area is measure by electric impedance variation. The difference in the distribution between the 4 areas will be measured (expressed as % of total ventilation).
Time frame: 4 hours
Plan to share: No
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Queen Fabiola Children's University Hospital