the ‘Effectiveness of routine nebulization of mucolytic agents and bronchodilating drugs in intubated and mechanically ventilated intensive care unit patients’ (NEBULAE) national multicenter randomized clinical trial determined the effect of routine nebulization of mucolytics and bronchodilators versus nebulization of mucolytics or bronchodilators only on clinical indication on the number of ventilator free days at day 28 in 922 critically ill patients receiving mechanical ventilation

NEBULAE is registered at clinicaltrials (NCT02159196); the study protocol was published in TRIALS (2015; 16:389); the primary analysis was published in JAMA (2018; 319:993)

the database of NEBULAE is harmonized with those from other randomized clinical trials in a pooled database named ‘Without ARDS’ (WizARDS)

connect with Frederique Paulus for secondary analyses of the NEBULAE database

the ‘PRotective VENTilation in patients without ARDS at start of ventilation’ (PReVENT) national multicenter randomized clinical trial determined the effect of a lung–protective ventilation strategy with lower tidal volumes versus ventilation using traditionally sized tidal volumes on the number of ventilator free days at day 28 in 961 critically ill patients receiving mechanical ventilation

PReVENT is registered at clinicaltrials (NCT02153294); the study protocol was published in TRIALS (2015; 16:226); the primary analysis was published in JAMA (2018; 320:1872)

the database of PReVENT is harmonized with those from other randomized clinical trials in a pooled database named ‘Without ARDS’ (WizARDS)

connect with Marcus Schultz for secondary analyses of the PReVENT database

the ‘Restricted versus Liberal PEEP in patients without the ARDS’ (RELAx) national multicenter randomized clinical trial determined the effect of high PEEP versus low PEEP on the number of ventilator free days at day 28 in 980 critically ill patients receiving mechanical ventilation

RELAx is registered at clinicaltrials (NCT03167580); the study protocol was published in TRIALS (2018; 19:272); the primary analysis was published in JAMA (2020; 324:2509)

the database of RELAx is harmonized with those from other randomized clinical trials in a pooled database named ‘Without ARDS’ (WizARDS)

connect with Frederique Paulus for secondary analyses of the NEBULAE database

the ‘Conservative versus Liberal Oxygenation Targets in Intensive Care Unit Patients’ (ICONIC) international multicenter randomized clinical trial determined the effect of a low oxygenation strategy versus a high oxygenation strategy on 28–day mortality in 646 critically ill patients with an expected ventilation duration of at least 24 hours

ICONIC is registered in the National Trial Register and the International Clinical Trials Registry Platform (NTR7376); the study protocol was published in TRIALS (2022; 23:136); the primary analysis was published in the American Journal of Respiratory and Critical Care Medicine (2023; 208:770)

the database of ICONIC is available for secondary analyses; one analysis focusing on weaning and extubation failure (W–ICONIC) is currently being conducted

the ‘Fully automated postoperative ventilation in cardiac surgery patients’ (POSITiVE) singlecenter randomized clinical trial determined the effect of automated ventilation by means of INTELLiVENT–ASV versus ventilation that was not automated on the quality of breathing in 220 patients after cardiac surgery

POSITiVE is registered at clinicaltrials (NCT03180203); the primary analysis was published in British Journal of Anesthesia (2020; 125:739)

‘Postoperative INTELLiVENT–adaptive support ventilation in cardiac surgery patients’ (POSITiVE II), an international multicenter randomized clinical trial, is the successor of POSITiVE

the database of POSITIVE is not available for secondary analyses

the ‘Closed–loop ventilation using sidestream versus mainstream capnography for automated adjustment of alveolar minute ventilation’ (INTELLiSTREAM) singlecenter randomized clinical trial determined the effect of automated ventilation that uses sidestream versus mainstream capnography on the quality of breathing in 73 patients after cardiac surgery

INTELLiSTREAM is registered at clinicaltrials (NCT04599491); the primary analysis was published in PLoS One (2023; 18:0289412)

connect with Marcus Schultz for secondary analyses of the INTELLiSTREAM database

the ‘The effect of closed–loop versus conventional ventilation on mechanical power’ (INTELLiPOWER) international multicenter randomized crossover trial determined the effect of INTELLiVENT–ASV versus conventional ventilation on the mechanical power of ventilation in 96 critically ill patients receiving mechanical ventilation

INTELLiPOWER is registered at clinicaltrials (NCT04827927); the primary analysis is currently under review

the database of INTELLiPOWER is not yet available for secondary analyses

the ‘Effect of automated closed–loop ventilation versus conventional ventilation on duration and quality of ventilation in critically ill patients’ (ACTiVE) international multicenter randomized clinical trial determines the effect of INTELLiVENT–ASV versus conventional ventilation on the number of ventilator free days at day 28 in 1200 critically ill patients receiving mechanical ventilation

INTELLiPOWER is registered at clinicaltrials (NCT04593810); the study protocol was published in TRIALS (2022; 23:348)

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the ‘Study Investigating the Efficacy and Safety of Nebulized HEParin versus Placebo in BURN Patients with Inhalation Trauma’ (HEPBURN) was an international multicenter randomized clinical trial investigating the effects of nebulized heparin versus placebo in critically ill invasively ventilated burn patients

HEPBURN is registered at clinicaltrials (NCT01773083); the study protocol was published in TRIALS (2014; 15:91); the safety and feasibility analysis was published in J Clin Med (2020; 9: 894)

the database of HEPBURN is not available for secondary analyses

the ‘study of PERMISSive Ventilation in critically ill patients’ (PERMISS) will be a multicenter randomized clinical trial into the effects of permissive ventilation versus conventional ventilation in critically ill invasively ventilated patients

PERMISS will soon be registered at clinicaltrials (pending); the study protocol will be published in TRIALS (pending)

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the ‘Postoperative INTELLiVENT–adaptive support ventilation in cardiac surgery patients’ (POSITiVE II) international multicenter randomized clinical trial determines the effect of automated ventilation by means of INTELLiVENT–ASV versus ventilation that is not automated on the quality of breathing in 328 patients after cardiac surgery

POSITiVE II is registered at clinicaltrials (NCT06178510); the study protocol was published in TRIALS (2024; 25:449)

POSITiVE II is the successor of the ‘Fully automated postoperative ventilation in cardiac surgery patients’ (POSITiVE) singlecenter randomized clinical trial

connect with the international coordinator for questions

the ‘Variable Pressure Support’ (ViPS) international multicenter randomized clinical trial compares variable with non–variable PSV with respect to the time to successful weaning, defined as the time from randomization to successful extubation

ViPS is registered at clinicaltrials (NCT01769053); the study protocol was published in TRIALS (2013: 14:363)

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the ‘Mechanicalinsufflation–exsufflation (cough assist) in critically ill adults’ (ACACIA) national multicenter randomized feasibility clinical trial tested the safety and feasibility of Mechanical Insufflation–Exsufflation (MI–E) in invasively ventilated critically ill patients

ACACIA is registered at clinicaltrials (NCT06027008); the study was stopped prematurely due to a slow inclusion rate

more information can be found here

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the ‘Early PReserved SPONtaneous Breathing Activity in Mechanically Ventilated Patients With ARDS’ (PReSPON) international multicenter randomized clinical trial determines the efficacy and safety of preserved spontaneous breathing activity during APRV in the early phase of moderate to severe ARDS in a total of 840 patients

PReSPON is registered at clinicaltrials (NCT04228471); the study protocol will be published (pending)

more information will be provided soon

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