Randomized controlled trials

Ranzomized controlled trials

flow–controlled ventilation in complex scenarios – improving intraoperative ventilation and outcomes

in the operating room, anesthesiologists ventilate patients during challenging procedures, such as minimally invasive abdominal surgery, bariatric surgery, or thoracic surgery with one–lung ventilation; flow–controlled ventilation generates smooth linear pressure changes with constant inspiratory and expiratory flow, keeping the lung open at end expiration and reducing mechanical stress; small studies have shown physiologic benefits and optimized ventilation; we conduct international multicenter pilot trials to test the safety and feasibility of flow–controlled ventilation, and larger trials on its impact on postoperative pulmonary complications

CORE VALUES of the PROFLOW Series

INTERVENTION

PROFLOW will investigate an intraoperative ventilation bundle, which includes FCV and a compliance–guided titration of PEEP and ΔP, based on dynamic compliance, aimed at maximum recruitment of lung tissue without overdistention

POPULATION

PROFLOW will include patients from various surgical scenarios including robot-assisted laparoscopic procedures, obeses patients schedules for bariatric surgery, or patients undergoing thoracic surgery in one-lung ventilation

OUTCOME

all studies of the PROFLOW Series will use 'postoperative pulmonary complications' as the primary endpoint; a new composite definition of 'postoperative pulmonary complications' is currently being developed and will be applied in these trials

PROJECTS within the PROFLOW Series

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 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 is under review and will be published soon, and patient enrollment has begun in February 2025

ROBOTic Main

this international multicenter randomized clinical will compare flow–controlled ventilation with pressure–controlled ventilation in patients scheduled for robot–assisted laparoscopic surgery

the objectives are to assess the impact of flow–controlled ventilation to improve postoperative pulmonary outcome and investigate its impact on the incidence of postoperative pulmonary complications in patients at higher risk of developing pulmonar undergoing robotic surgery (PROFLOW–ROBOTic)

PROFLOW–ROBOTic will be registered at clinicaltrials (pending); the study protocol will be published in TRIALS, and patient enrollment is set to begin 2026

the database of PROFLOW–ROBOTic will be harmonized to enable pooling with data from other flow–controlled studies

THORACic Pilot

this international multicenter randomized clinical pilot trial will compare flow–controlled ventilation with pressure–controlled ventilation in patients scheduled for thoracic surgery with one-lung ventilation

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 thoracic surgery with one-lung ventilation’ (PROFLOW–THORACic)

this pilot study will be registered at clinicaltrials soon; the study protocol will be published soon, and patient enrollment is set to begin 2026

THORACic Main

this international multicenter randomized clinical trial will compare flow–controlled ventilation with pressure–controlled ventilation in patients scheduled for thoracic surgery with one-lung ventilation

this study will be registered at clinicaltrials soon; the study protocol will be published soon, and patient enrollment is set to begin in 2027

BARIATRic Pilot

this international multicenter randomized clinical pilot trial will compare flow–controlled ventilation with pressure–controlled ventilation in obese patients scheduled for bariatric 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 in obese patients scheduled for bariatric surgery’ (PROFLOW–BARIATRic)

this pilot study will be registered at clinicaltrials soon; the study protocol will be published soon, and patient enrollment is set to begin 2027

BARIATRic Main

this international multicenter randomized clinical trial will compare flow–controlled ventilation with pressure–controlled ventilation in obese patients scheduled for bariatric surgery

the objectives are to assess the impact of flow–controlled ventilation to improve postoperative pulmonary outcome and investigate its impact on the incidence of postoperative pulmonary complications in obese patients at higher risk of developing pulmonary complications undergoing bariatric surgery ’ (PROFLOW–BARIATRic)

this study will be registered at clinicaltrials soon; the study protocol will be published soon, and patient enrollment is set to begin in 2028

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