Driving Pressure Guided Mechanical Ventilation Versus Lung Protective Ventilation Among Patients Undergoing Elective Surgeries

Not Applicable

Recruiting

• Conditions: Lung Protective Ventilation; Mechanical Ventilation; Driving Pressure

• Registration Number: NCT07092943
• Lead Sponsor: Rawalpindi Medical College

Brief Summary

Patient undergoing surgeries in general anesthesia require support of their breathing by ventilator. Different strategies can be used to manage breathing of the patient. Lung protective ventilation provides breathing at a set volume determined by patient ideal body weight, along with a set rate to maintain adequate breathing. The pressures in the lower airway are kept less than 30 cm of H20 while a pressure of 5cm of H20 is applied to prevent lung collapse. Recently to above mentioned regimen a driving pressure is added which is a difference between lower airway pressure and pressure applied to prevent lung collapse. Ventilatory settings are adjusted to keep this driving pressure less than 15 cm of H2O.

Detailed Description

Lung protective ventilation provides tidal volume at 6-8 ml/kg along with a set respiratory while keeping plateau pressure less than 30cm of H2O and Peak pressure less than 35cm of H2O and PEEP of 5cm of H20 is applied. The aim is to prevent volutrauma, barotrauma and atelectrauma. To above mentioned regimen another parameter is added that is driving pressure. It is manipulated by adjusting PEEP level so that difference between Plateau Pressure and PEEP is less than equal to 15cm of water.

Study Timeline

• Status Verified: 2025-07
• Study Start: 2025-07-20
• Study First Submitted: 2025-07-20
• Study First Submitted QC: 2025-07-28
• Last Update Submitted: 2025-07-28
• Study First Posted: 2025-07-30
• Last Update Posted: 2025-07-30
• Primary Completion: 2025-10-20
• Study Completion: 2025-10-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• American Society of Anesthesiologists (ASA) class: I and II.
• Elective laparoscopic surgeries requiring General Anesthesia and Mechanical ventilation
• Patients receiving neuromuscular blockade during surgery.
• Receiving Mechanical ventilation for at least 1h.

Exclusion Criteria

• Pregnancy
• Patients who had received mechanical ventilation of more than 1h in the previous 2 weeks.
• Body mass index >35 kg/m2
• Smokers and ASA class III and above.
• Thoracic and Cardiac surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Intra-operative pulmonary compliance	This will be measured at 10 minutes interval in the intraoperative period and then mean will be calculated.

Secondary Outcome Measures

Name	Time	Method
Oxygenation index	This will be the ratio of PaO2/FiO2 and this will be measured during surgery (at time of skin closure)
PEtCO2-PaCO2 gradient	This will be the PEtCO2-PaCO2 gradient and this will be measured during surgery (at time of skin closure)
Post operative pulmonary complications	This will be the need for prolonged ventilatory support, need for re-intubation ,need for supplemental oxygenation and its duration, PaO2/FiO2 ratio less than 300, pneumothroax. These will be observed in first 24hours after surgery.
Intra-operative blood pressure	This will be Systolic, Diastolic and Mean Blood pressure measured at baseline and then 10 minutes interval in the intraoperative period. Mean will be calculated for comparison across groupss.

Trial Locations

Locations (1)

Benazir Bhutto Hospital; 🇵🇰 Rawalpindi, Punjab, Pakistan