None listed
Conditions
Brief summary
Many patients are admitted to hospital each year for a laparoscopic surgical procedure. At times, the procedure requires general anaesthesia and mechanical ventilation. General anaesthesia means that you will be unaware of the procedure as it is happening and mechanical ventilation involves the placement of a breathing tube into the upper airway to support breathing and oxygenation. Two key components of mechanical ventilation are tidal volume (volume of air breathed and positive-end expiratory pressure (PEEP)(pressure in the lungs after breathing out). Traditionally, for patients having laparoscopic surgery conventional tidal volumes (10 to 15 ml per kilogram of predicted body weight) are used as a means to prevent low-blood oxygen or lung tissue collapse. However, studies involving people suggests that high tidal volumes are injurious to healthy lungs and can cause localised inflammation. Similarly, accumulating data from observational and small randomized controlled human studies have found that high tidal volumes can damage the lungs. Conversely, using low tidal volumes (6 ml per kilogram of predicated body weight) during mechanical ventilation has been shown to be beneficial in patients suffering from acute respiratory distress syndrome. Indeed, low tidal volume ventilation has been adopted for the management of critically ill patients at risk of respiratory distress syndrome. At the present time it is unclear whether a higher tidal volume strategy – conventional ventilation, or a lower tidal volume strategy – known as protective ventilation, during mechanical ventilation for patients having laparoscopic surgery requiring general anaesthesia. We believe that the information obtained from this study will help anaesthetists to better manage the ventilator management for patients who are having a laparoscopic surgical procedure that requires general anaesthesia. This study will involve 1750 patients admitted to hospital to have laparoscopic surgery under general anaesthesia. The research has been initiated by the researchers at the Austin Hospital (Melbourne) and is anticipated it will take two years to complete.
Interventions
Low tidal volume and high positive end-expiratory pressure (6 ml/kg of predicted body weight and 12 cmH2O of positive end-expiratory pressure) will be delivered via a mechanical ventilatory during major laparoscopic surgery with an expected during of more than two hours. It is anticipated minimum and maximum duration that the ventilation will be applied will be 2.5 hours to 6 hours, depending on the length of the procedure. The intervention will be administered and monitored by the treating anae
Low tidal volume and high positive end-expiratory pressure (6 ml/kg of predicted body weight and 12 cmH2O of positive end-expiratory pressure) will be delivered via a mechanical ventilatory during major laparoscopic surgery with an expected during of more than two hours. It is anticipated minimum and maximum duration that the ventilation will be applied will be 2.5 hours to 6 hours, depending on the length of the procedure. The intervention will be administered and monitored by the treating anaesthetist. Adherence to the allocation intervention arm will be via an audit of operation reports.
Sponsors
Austin Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Investigator)
Eligibility
Sex/Gender
All
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Equal to or greater than 40 years Scheduled to have major laparoscopic surgery (including robotic surgery) with an expected duration of more than two hours Expected to have invasive arterial pressure monitoring as part of their routine care
Exclusion criteria
Pregnancy Scheduled to have cardiac, thoracic, or intracranial neurological surgery Need of nitrous oxide administration Previously had lung surgery Planned reintubation after surgery (e.g., planned re-operations) Received invasive ventilation for longer than 12 hours within the last 30 days prior to surgery Any other contra-indication to hypercapnia Previous randomization into this clinical trial
Outcome results
None listed