RCTs in the OR
RCTs in the OR
connect with Denise Battaglini or Chiara Robba for general inquiries about the featured trials; each trial includes a specific contact address for trial–related questions
[1] PROVHILO
the ‘PROtective Ventilation with high or low PEEP for open abdominal surgery’ (PROVHILO) international multicenter randomized clinical trial determined the effect of high PEEP plus recruitment maneuvers versus low PEEP on postoperative pulmonary complications in 900 patients at high risk for postoperative pulmonary complications receiving mechanical ventilation during general anesthesia for open abdominal surgery
PROVHILO is registered at clinicaltrials (NCT01441791); the study protocol was published in TRIALS (2011; 12:111); the primary analysis was published in THE LANCET (2014; 384:495)
the database of PROVHILO is harmonized with those from other randomized clinical trials in a pooled database named ‘Re–evaluation of the effects of high PEEP with recruitment maneuvers versus low PEEP without recruitment maneuvers during general anesthesia’ (REPEAT)
connect with Sabrine Hemmes or Lorenzo Ball for secondary analyses of the PROVHILO database
[2] PROBESE
the ‘PRotective ventilation of OBESE patients’ (PROBESE) international multicenter randomized clinical trial determined the effect higher PEEP plus recruitment maneuvers versus low PEEP on postoperative pulmonary complications in 1976 obese patients at high risk for postoperative pulmonary complications receiving mechanical ventilation during general anesthesia for surgery
PROBESE is registered at clinicaltrials (NCT02148692); the study protocol was published in TRIALS (2017; 18:202); the primary analysis was published in JAMA (2019; 321:2292)
the database of PROBESE is harmonized with those from other randomized clinical trials in a pooled database named ‘Re–evaluation of the effects of high PEEP with recruitment maneuvers versus low PEEP without recruitment maneuvers during general anesthesia’ (REPEAT)
connect with Sabrine Hemmes or Lorenzo Ball for secondary analyses of the PROBESE database
[3] PROVAR
the 'PROtective VARiable ventilation' (PROVAR) singlecenter randomized clinical trial compared conventional (non–variable) lung protective ventilation with variable lung protective ventilation regarding pulmonary function and inflammatory response
PROVAR is registered at clinicaltrials (NCT01683578); the study protocol was published in TRIALS (2014; 15:155); the primary analysis was published in British Journal of Anaesthesioloy (2018; 120:581)
connect with Marcelo Gama de Abreu for secondary analyses of the PROVAR database
[4] LoCo
the ‘Low versus Conventional tidal volumes during one–lung ventilation for minimally invasive oesophagectomy trial’ (LoCo) singlecenter randomized clinical trial compared intraoperative protective ventilation with conventional ventilation during esophagectomy with respect to pulmonary levels of biomarkers for inflammation and lung injury
LoCo is registered at Netherlands Trial Register (NTR 4391); the primary analysis was published in European Journal of Anaesthesiology (2019; 321:2292)
connect with Marcus Schultz for secondary analyses of the LoCo database
[5] PROTHOR
the ‘Protective ventilation with high versus low PEEP during one–lung ventilation for thoracic surgery’ (PROTHOR) international multicenter randomized clinical trial determines the effect higher PEEP plus recruitment maneuvers on postoperative pulmonary complications in 2378 patients at high risk for postoperative pulmonary complications receiving mechanical ventilation during general anesthesia for thorax surgery
PROTHOR is registered at clinicaltrials (NCT02963025); the study protocol was published in TRIALS (2019; 20:213); the study has been completed and the results have been submitted to a peer–reviewed journal
for more information visit the PROTHOR website
contact us in case you have questions
[6] DESIGNATION
the ‘Driving pressure during general anesthesia for abdominal surgery’ (DESIGNATION) international multicenter randomized clinical trial determines the effect of individualized high PEEP versus low PEEP on postoperative pulmonary complications in 1468 patients at high risk for postoperative pulmonary complications receiving mechanical ventilation during general anesthesia for abdominal surgery
DESIGNATION is registered at clinicaltrials (NCT03884543); the study protocol was published in TRIALS (2020; 21:198); the study has been completed and the analyses will start soon
the database of DESIGNATION will be harmonized to allow pooling of the data in ‘Re–evaluation of the effects of high PEEP with recruitment maneuvers versus low PEEP without recruitment maneuvers during general anesthesia’ (REPEAT)
contact us in case you have questions
[7] GENERATOR
the ‘Driving pressure during general anesthesia for minimally invasive abdominal surgery’ (GENERATOR) international multicenter randomized clinical trial determines the effect of individualized high PEEP versus low PEEP on postoperative pulmonary complications in 1806 patients at high risk for postoperative pulmonary complications receiving mechanical ventilation during general anesthesia for minimally invasive abdominal surgery
GENERATOR is registered at clinicaltrials (NCT06101511); the study protocol was published in TRIALS (2024; 25:719)
the database of GENERATOR will be harmonized to allow pooling of the data in ‘Re–evaluation of the effects of high PEEP with recruitment maneuvers versus low PEEP without recruitment maneuvers during general anesthesia’ (REPEAT)
for more information visit the GENERATOR website
contact us in case you have questions
[8] PROFLOW–ROBOTic pilot
this international multicenter randomized clinical pilot trial will compare flow–controlled ventilation with pressure–controlled ventilation in patients scheduled for robot–assisted laparoscopic abdominal, urologic, or gynecologic surgery
the objectives are to assess the safety of flow–controlled ventilation and the feasibility of the study, while also informing the design of a future trial, named ‘PROtective ventilation with FLOW–controlled ventilation to improve postoperative pulmonary outcome after ROBOT–assisted laparoscopic surgery’ (PROFLOW–ROBOTic)
this pilot study is registered at clinicaltrials (NCT06703814); the study protocol will be published soon, and patient enrollment is set to begin in February 2025
contact us in case you have questions
[9] PROFLOW–ROBOTic
the ‘PROtective ventilation with FLOW–controlled ventilation to improve postoperative pulmonary outcome after ROBOT–assisted laparoscopic surgery’ (PROFLOW–ROBOTic) international multicenter randomized clinical trial determines the effect of flow–controlled ventilation versus conventional ventilation on postoperative pulmonary complications in patients at high risk for postoperative pulmonary complications receiving mechanical ventilation during general anesthesia for laparoscopic robotic–assisted surgery
PROFLOW–ROBOTic will be registered at clinicaltrials (pending); the study protocol will be published in TRIALS
the database of PROFLOW–ROBOTic will be harmonized to allow pooling of the data in ‘Re–evaluation of the effects of high PEEP with recruitment maneuvers versus low PEEP without recruitment maneuvers during general anesthesia’ (REPEAT)
for more information visit the PROFLOW–ROBOTic website (available soon)
contact us in case you have questions
[10 & 11] PLANNED STUDIES
we are currently planning two additional studies similar to PROFLOW–ROBOTic; these international multicenter randomized clinical trials to determine the effect of flow—controlled ventilation versus conventional ventilation on postoperative pulmonary complications in obese patients and in those undergoing thorax surgery
these studies will be registered at clinicaltrials and prepublications will be submitted to TRIALS
as with other studies, the database of PROFLOW–bariatric and PROFLOW–thoracic will be harmonized to allow pooling of the data in ‘Re–evaluation of the effects of high PEEP with recruitment maneuvers versus low PEEP without recruitment maneuvers during general anesthesia’ (REPEAT)
more information will follow soon
contact us in case you have questions
connect with us if you want to join one of the running studies