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Comparison of two different ventilation strategies during general anaesthesia for reducing lung complications after robotic surgeries of abdomen and pelvis

Comparison of Modified Lung Ultrasound Score (LUSS) in patients undergoing robot assisted abdominal and pelvic surgeries in Trendelenburg position under general anesthesia with driving pressure targeted individualized PEEP versus empiric fixed PEEP - A Randomized Controlled Trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/02/080999
Enrollment
80
Registered
2025-02-20
Start date
Unknown
Completion date
Unknown
Last updated
2025-03-03

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: Driving Pressure Guided PEEP: Mode of ventilation is VCV Tidal volume will be 7 ml per kg PBW RR to target EtCO2 of 35 to 40 mm Hg FiO2 to target SpO2 more than 98 percentage PEEP will

Sponsors

Ananya Kabi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients between 18 and 75 years of age, American Society of Anesthesiologists physical status II or III, body mass index between 18 kg per m2 and 35 kg per m2, with intermediate to high ARISCAT score ,that is more than 26, planned for robotic abdominal and pelvic surgeries under general anesthesia in Trendelenburg position 2. Duration of surgery more than 3 hours, from the time of creation of the pneumoperitoneum, like surgeries for prostate, rectum, total laparoscopic hysterectomy, etc. 3. Patients expected to be extubated on table post operatively

Exclusion criteria

Exclusion criteria: 1. Patients with history of acute respiratory distress Syndrome 2. Emergency surgery 3. History of previous lung surgery 4. History of mechanical ventilation within 2 weeks before recruitment 5. Pregnant patients 6. Patients with cardiac comorbidities of NYHA class III and IV 7. Patients with valvular heart diseases 8. Patients with history of stroke 9. Patients with elevated intracranial pressure 10. Severe Chronic obstructive pulmonary disease with Forced expiratory volume to Forced vital capacity ratio less than 60 percent 11. History of progressive neuromuscular illness 12. Participation in another study 13. Refusal to participate 14. Anaesthesiologist unwilling to adhere to the ventilation mode as specified

Design outcomes

Primary

MeasureTime frame
To compare LUSS in patients with intermediate to high risk of PPCs, that is ARISCAT score more than2 6, undergoing robot assisted abdominal and pelvic surgeries under general anesthesia in Trendelenburg position with driving pressure directed individualized PEEP versus empiric fixed PEEPTimepoint: Lung ultrasound will be conducted pre-induction (t1), end of surgery pre extubation (t2), post extubation (t3)

Secondary

MeasureTime frame
1.To compare the differences in peak inspiratory pressure (PIP), plateau pressures, PEEP, Partial pressure of oxygen in arterial blood/Fraction of inspired oxygen (PaO2/FiO2) in patients undergoing robotic abdominal and pelvic surgeries under general anesthesia with intraoperative targeted driving pressures and conventional ventilation strategies 2. To compare the incidence of postoperative pulmonary complications (PPC) in patients undergoing laparoscopic abdominal surgeries under general anesthesia between the groups 3. To correlate the Lung ultrasound score to development of postoperative pulmonary complications 4. To compare the serum levels of HS-CRP, TNF-a and IL-1ß in patients undergoing robotic abdominal and pelvic surgeries under general anesthesia with intraoperative targeted driving pressures and conventional ventilation strategiesTimepoint: Recordings will be done at 5 predefined time points, after intubation (t1), 10 minutes after pneumoperitoneum and Trendelenburg (t2), 1 hour(t3) and 2 hours (t4) after t2 and 10 minutes after PEEP has been reset before extubation (t5) for Peak and plateau pressures, PEEP and compliance and ABG for PaO2/FiO2, A-a gradient, PCO2. Blood samples for serum markers will be collected pre induction (t1) and post extubation (t2).

Countries

India

Contacts

Public ContactAnusha Cherian

Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry.

anushacherian@gmail.com9789197801

Outcome results

None listed

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