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

NCT07092943 | Recruiting DMC FDA Device

• 1 other identifier: 200/IREF/RMU/2025
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Mechanical Ventilation; Lung Protective Ventilation; Driving Pressure

Keywords

General Anesthesia; Mechanical ventilation

Outcome Measures

Primary Outcomes (1)

• Intra-operative pulmonary compliance

  This will be measured at 10 minutes interval in the intraoperative period and then mean will be calculated.

Secondary Outcomes (4)

• 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)

• 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.

• 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.

Study Arms (2)

Lung Protective ventilation

SHAM COMPARATOR

Device: Lung protective ventilation

Driving pressure guided ventilation

EXPERIMENTAL

Device: Driving pressure guided ventilation

Interventions

Lung protective ventilation DEVICE

The patient in this group will receive tidal volume at 6-8 ml/kg of ideal body weight with PEEP of 5 cm of H2O and plateau pressure will be kept less than 30cm of H2O.

Lung Protective ventilation

Driving pressure guided ventilation DEVICE

They will receive tidal volume of 6-8 ml/kg of ideal body weight and initial PEEP of 5 cm of water. Principal investigator will then incrementally increase PEEP by 2 cm of water till a value 15 cm of water PEEP is reached or Plateau pressure becomes equal to 30 cm of water or driving pressure starts to increase or there is change in any hemodynamics. Each incremental PEEP will last for 3 respiratory cycles before moving on to next value. PEEP value with lowest driving pressure will then be selected for the duration of surgical procedure

Driving pressure guided ventilation

Eligibility Criteria

• Age: 16 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Rawalpindi Medical College: lead

Study Sites (1)

Benazir Bhutto Hospital

Rawalpindi, Punjab Province, 46000, Pakistan

RECRUITING

Related Publications (1)

• Park M, Yoon S, Nam JS, Ahn HJ, Kim H, Kim HJ, Choi H, Kim HK, Blank RS, Yun SC, Lee DK, Yang M, Kim JA, Song I, Kim BR, Bahk JH, Kim J, Lee S, Choi IC, Oh YJ, Hwang W, Lim BG, Heo BY. Driving pressure-guided ventilation and postoperative pulmonary complications in thoracic surgery: a multicentre randomised clinical trial. Br J Anaesth. 2023 Jan;130(1):e106-e118. doi: 10.1016/j.bja.2022.06.037. Epub 2022 Aug 20.

  PMID: 35995638 BACKGROUND

Related Links

• Related Info

Central Study Contacts

Huda Tariq, MBBS

CONTACT

+92-321-8829413; Huda8829@gmail.com

Abeera Zareen, MBBS,FCPS

CONTACT

+92-332-8559637; abeerajsk@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 20, 2025
• First Posted: July 30, 2025
• Study Start: July 20, 2025
• Primary Completion: October 20, 2025
• Study Completion: October 20, 2025
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)