Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07092943

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

16 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Abeera Zareen, MBBS,FCPS

CONTACT

[email protected]

+92-332-8559637

Huda Tariq, MBBS

CONTACT

[email protected]

+92-321-8829413

Sponsors and collaborators

Lead sponsor

Rawalpindi Medical College

Other

Registry information

Official study title

A Comparison of Driving Pressure Guided Mechanical Ventilation With Lung Protective Ventilation Among Patients Presenting for Elective Surgeries at a Tertiary Care Hospital; A Randomized Control Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 30, 2025
Registry last updated
Jul 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.