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RecruitingNCT07092943Updated Jul 30, 2025

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

An interventional study of Lung protective ventilation and Driving pressure guided ventilation in Mechanical Ventilation, Lung Protective Ventilation and Driving Pressure, sponsored by Rawalpindi Medical College. Recruiting at 1 site in Pakistan. Open to participants aged 16 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-30.

Sponsored by Rawalpindi Medical College · Not applicable, Interventional, and Other

From the registry’s dates

  • Primary completion was expected by Oct 2025, 11 months ago, but the record still lists the study as recruiting.
  • Started Jul 2025; still recruiting 1 year 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
16 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Mechanical Ventilation
  • Lung Protective Ventilation
  • Driving Pressure

Keywords

  • General Anesthesia
  • Mechanical ventilation
03

In context

Lead sponsor

Rawalpindi Medical College is the lead sponsor of 22 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
70 participants (estimated)

Study arms

  • Sham comparator
    Lung Protective ventilation

    Device: Lung protective ventilation

  • Experimental
    Driving pressure guided ventilation

    Device: Driving pressure guided ventilation

Interventions

  • DeviceLung protective ventilation

    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.

  • DeviceDriving pressure guided ventilation

    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

06

What researchers measure

Primary outcomes

  1. Intra-operative pulmonary compliance

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

Secondary outcomes

  1. Oxygenation index

    Time frame: This will be the ratio of PaO2/FiO2 and this will be measured during surgery (at time of skin closure)

  2. PEtCO2-PaCO2 gradient

    Time frame: This will be the PEtCO2-PaCO2 gradient and this will be measured during surgery (at time of skin closure)

  3. Intra-operative blood pressure

    Time frame: 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.

  4. Post operative pulmonary complications

    Time frame: 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.

07

Study locations

1 of 1 sites recruiting
  • Benazir Bhutto Hospital
    Rawalpindi, Punjab Province 46000, Pakistan
    Recruiting
08

References and documents

Publications

  • 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. PubMed 35995638 ↗

Related links

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 30, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07092943
Lead sponsor
Rawalpindi Medical College
Responsible party
Huda Tariq (Principal Investigator, Rawalpindi Medical College) — Principal investigator
First posted
Jul 30, 2025
Start date
Jul 20, 2025
Primary completion
Oct 20, 2025 (estimated)
Completion
Oct 20, 2025 (estimated)
Last update
Jul 30, 2025

Study contacts

Huda Tariq, MBBS
Contact
Huda8829@gmail.com
+92-321-8829413
Abeera Zareen, MBBS,FCPS
Contact
abeerajsk@gmail.com
+92-332-8559637

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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