NCT04506736

Open Lung Approach Versus Conventional Protective Ventilation in Obese Patients Undergoing Open Abdominal Surgery

Open Lung Approach Versus Conventional Protective Ventilation in Obese Patients Undergoing Open Abdominal Surgery: A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Zagazig University · Other Government
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

the purpose of this study is to compare open lung approach versus conventional protective ventilation in obese patients undergoing open abdominal surgery

Detailed description

after being informed about the study and potential risks. All patients giving written consent will be randomized by double blind manner into 2 groups each one containing 24 patients Group SPV: will be ventilated using volume controlled ventilation (7ml/kg tidal volume) with addition of 5 cm H₂O fixed PEEP till the end of the surgery . Group OLA: The patients will undergo ARM followed by personalized PEEP.

Conditions

• Abdominal Surgery
• Obese Patients

Interventions

Type	Name	Description
OTHER	ARM	The ARM is performed by setting the peak inspiratory pressure to 45 cmH₂O then changing the mode of ventilation to pressure controlled ventilation (PCV) with the inspiratory pressure set to give a tidal volume equal to that given during VCV, I:E ratio of 1:1 and a PEEP of 5 cmH₂O. The PEEP level is then increased in 5 cmH₂O steps every minute till it reaches 20 cmH₂O and inspiratory pressure is increased to get an airway opening pressure (inspiratory pressure + PEEP) of 40 cmH₂O which is maintained for one minute after which the ventilation returned to the original setting except for the PEEP level which is kept at 20 cmH₂O. The titration of individualized PEEP is done by decremental reduction of the 20 cmH₂O PEEP level in 2 cmH₂O steps every 2 minutes and measuring static compliance of the respiratory system (CRS) at each step.
OTHER	spontanous ventilation	volume controlled ventilation (7ml/kg tidal volume) with addition of 5 cm H₂O fixed PEEP till the end of the surgery .

Timeline

• Start date: 2020-08-15
• Primary completion: 2022-03-30
• Completion: 2022-04-30
• First posted: 2020-08-10
• Last updated: 2022-05-24

Locations

1 site across 1 country: Egypt