NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT1042230139

Registered date:26/01/2024

Positive end-expiratory pressure during pneumoperitoneum changes the Electrical Impedance Tomography ventilation distribution in pediatric patients.

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedPediatric patients (2-12 years old) undergoing laparoscopic inguinal hernia surgery
Date of first enrollment26/01/2024
Target sample size40
Countries of recruitment
Study typeInterventional
Intervention(s)In pediatric patients, randomized to change PEEP from 0 to 5 cmH2O during pneumoperitoneum (P5 group) or from 0 to 10 cmH2O (P10 group) and evaluate lung compliance and percentage of ventilation distribution using EIT system

Outcome(s)

Primary OutcomeChange in dorsal ventilation rate 10 minutes after changing to PEEP 5 or PEEP 10, using the baseline before the start of surgery
Secondary OutcomeChange in dorsal ventilation rate 5 minutes after the start of pneumoperitoneum, using the baseline before the start of surgery as the baseline. Driving pressure, peak pressure, alveolar plateau pressure, static compliance, and vital signs at each measurement point

Key inclusion & exclusion criteria

Age minimum>= 2age old
Age maximum<= 12age old
GenderBoth
Include criteria1. children between 2 and 12 years of age 2. patients diagnosed with inguinal hernia who will undergo laparoscopic surgery (scheduled surgery) under general anesthesia 3. who are scheduled to be intubated with muscle relaxants 4. who will undergo surgery in the supine position 5. who have obtained consent for participation in this study by signing a consent form by a surrogate
Exclude criteria1. those with respiratory complications such as asthma or active upper airway inflammation as a preoperative complication 2. Patients with skin disease in the area of the EIT 3. Patients with a chest circumference of less than 50 cm 4. who cannot wear the EIT due to thoracic deformity 5. Patients with congenital heart disease requiring treatment 6. Subjects with neuromuscular diseases 7. other subjects whom the investigator deems inappropriate to be included in this study.

Related Information

Contact

Public contact
Name Masahiro Yagihara
Address 1-20-1,Handayama,Chuo-ku,Hamamatsu,Shizuoka Shizuoka Japan 431-3192
Telephone +81-53-435-2738
E-mail ewf.yagi@outlook.jp
Affiliation Hamamatsu University Hospital
Scientific contact
Name Masahiro Yagihara
Address 1-20-1 Handayama,Chuo-ku,Hamamatsu sity,Shizuoka Shizuoka Japan 431-3192
Telephone +81-53-435-2738
E-mail ewf.yagi@outlook.jp
Affiliation Hamamatsu University Hospital