Last updated: February 19, 2024
Sponsor: Queen Fabiola Children's University Hospital
Overall Status: Active - Recruiting
Phase
N/A
Condition
N/ATreatment
General anesthesia with mask ventilation
General anesthesia with spontaneous laryngeal mask ventilation with pressure support
General anesthesia and spontaneous laryngeal mask ventilation
Clinical Study ID
NCT06262360
P2023457
Ages 1-6 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Children undergoing elective circumcision
- Age 1 to 6 years
- ASA class I or II
Exclusion
Exclusion Criteria:
- Any history of lung diseases, congenital heart diseases or abdominal diseases thatcould interfere with lungs dynamic.
- ASA physical status11 > II.
- Patients whose weight is less than 10 kg.
- The use of Jackson-Rees device12.
- Contraindication for premedication.
- Contraindication for mask ventilation or laryngeal mask ventilation13.
- Contraindication for regional anesthesia.
- Need for opioids administration during surgery.
- Patients with uncontrollable movements of the body.
- Inability of parents/tutors to understand French or Dutch.
- Patients whose parents do not agree with their participation in the study
- Patients with thoracic perimeters (between 4th and 6th ribs) less than 37.5 cm (minimal size for the pediatric EIT belt) or more than 72 cm (maximal size for thepediatric EIT belt)
- Patients with damaged skin or impaired skin contact of the electrodes due to wounddressings.
- Patients with spinal lesions or fractures (acute or recent)
- Patients with pacemaker, defibrillators, or other electrically active implants
Study Design
Total Participants: 60
Treatment Group(s): 4
Primary Treatment: General anesthesia with mask ventilation
Phase:
Study Start date:
February 16, 2024
Estimated Completion Date:
September 30, 2024
Connect with a study center
H.U.B - Hôpital Universitaire des Enfants Reine Fabiola
Brussels, 1020
BelgiumActive - Recruiting
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