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 |
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Health condition(s) or Problem(s) studied | Pediatric patients (2-12 years old) undergoing laparoscopic inguinal hernia surgery |
Date of first enrollment | 26/01/2024 |
Target sample size | 40 |
Countries of recruitment | |
Study type | Interventional |
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 Outcome | Change in dorsal ventilation rate 10 minutes after changing to PEEP 5 or PEEP 10, using the baseline before the start of surgery |
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Secondary Outcome | Change 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 |
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Age maximum | <= 12age old |
Gender | Both |
Include criteria | 1. 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 criteria | 1. 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
Primary Sponsor | Yagihara Masahiro |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) |
Contact
Public contact | |
Name | Masahiro Yagihara |
Address | 1-20-1,Handayama,Chuo-ku,Hamamatsu,Shizuoka Shizuoka Japan 431-3192 |
Telephone | +81-53-435-2738 |
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 |
ewf.yagi@outlook.jp | |
Affiliation | Hamamatsu University Hospital |