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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07092943
Enrollment
70
Registered
2025-07-30
Start date
2025-07-20
Completion date
2025-10-20
Last updated
2025-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mechanical Ventilation, Lung Protective Ventilation, Driving Pressure

Keywords

General Anesthesia, Mechanical ventilation

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.

Interventions

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.

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

Sponsors

Rawalpindi Medical College
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
16 Years to 80 Years
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

* 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

Design outcomes

Primary

MeasureTime frame
Intra-operative pulmonary complianceThis will be measured at 10 minutes interval in the intraoperative period and then mean will be calculated.

Secondary

MeasureTime frame
Oxygenation indexThis will be the ratio of PaO2/FiO2 and this will be measured during surgery (at time of skin closure)
PEtCO2-PaCO2 gradientThis will be the PEtCO2-PaCO2 gradient and this will be measured during surgery (at time of skin closure)
Intra-operative blood pressureThis 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 complicationsThis 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.

Countries

Pakistan

Contacts

Primary ContactHuda Tariq, MBBS
Huda8829@gmail.com+92-321-8829413
Backup ContactAbeera Zareen, MBBS,FCPS
abeerajsk@gmail.com+92-332-8559637

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026