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A clinical trial to study the effect of intraabdominal pressure guided positive end expiratory pressure on driving pressure in paediatric laparoscopic surgery

Effect Of Intraabdominal Pressure Guided Positive End Expiratory Pressure on Driving Pressure In Paediatric Laparoscopic Surgery: A Randomized Controlled Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/03/041242
Enrollment
60
Registered
2022-03-21
Start date
Unknown
Completion date
Unknown
Last updated
2023-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: PEEP of 8 CmH2O plus 50% of abdominal pressure will be applied: Initially PEEP of 8 CmH2O will be applied after induction of anaesthesia and maintained up to five minutes after pneumope
lung will be recruited as per recruitment protocol. After lung recruitment PEEP of 8cmH20 + 50% of abdominal pressure will be applied. This PEEP will be maintained till deflation of pneumoperitoneum.

Sponsors

Rakesh Kumar
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Parents willing to give consent for inclusion in study 2. Children age more than one year and less than 12 years(1-12yrs). 3. American society of anaesthesiology(ASA) physical status less than IV. 4. Elective laparoscopic surgery of more than one hour of pneumoperitoneum and in lateral position

Exclusion criteria

Exclusion criteria: 1. Parental refusal to participate in the study. 2. Children with known severe lung disease. 3. Children with a history of severe lung infection having post infection sequelae in preoperative chest x-ray. 4. Children with known deformity of chest wall or thoracic spine. 5. Children with pre-existing significant cardiac, renal or hepatic diseases. 6. Children with history of previous thoracic surgery. 7. Children with BMI > 30 kg/m2

Design outcomes

Primary

MeasureTime frame
Change in driving pressure in both groups at the end of pneumoperitonium.Timepoint: Change in driving pressure in the both groups at the end of pneumoperitoneum

Secondary

MeasureTime frame
1.Peak airway pressure , Plateau pressure and mean airway pressure at the end of pneumoperitonium and 15 minutes interval during pneumoperitonium. 2.static lung compliance at the end of pneumoperitonium and 15 minutes interval during pneumoperitonium. 3.lung ultrasound score after induction and one hour after extubation. 4.PaO2/FiO2 ratio, alveolar-arterial oxygen gradient and PaCO2 and ETCO2 difference 5. Room air oxygen saturation 6. Incidence of intraoperative hypotension and Bradycardia Timepoint: 1 at end of pneumoperitoneum 2 at end of pneumoperitoneum 3 after induction and 1 hour post extubation 4after pneumoperitoneum and pneumoperitoneum deflation 5 post-op day 1or3 or at time of discharge whichever earlier 6. Intraoperative

Countries

India

Contacts

Public ContactRakesh Kumar

All India Institute of Medical Sciences, New Delhi

drrakesh.kumar.akb@gmail.com7838043581

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026