Sigh in Acute Hypoxemic Respiratory Failure (PROTECTION)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03201263|
Recruitment Status : Unknown
Verified June 2017 by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico.
Recruitment status was: Recruiting
First Posted : June 28, 2017
Last Update Posted : July 2, 2017
Mortality of intubated acute hypoxemic respiratory failure (AHRF) and acute respiratory distress syndrome (ARDS) patients remains considerably high (around 40%) (Bellani 2016). Early implementation of a specific mechanical ventilation mode that enhances lung protection in patients with mild to moderate AHRF and ARDS on spontaneous breathing may have a tremendous impact on clinical practice.
Previous studies showed that the addition of cyclic short recruitment maneuvers (Sigh) to assisted mechanical ventilation: improves oxygenation without increasing ventilation pressures and FiO2; decreases the tidal volumes by decreasing the patient's inspiratory drive; increases the EELV by regional alveolar recruitment; decreases regional heterogeneity of lung parenchyma; decreases patients' inspiratory efforts limiting transpulmonary pressure; improves regional compliances. Thus, physiologic studies generated the hypothesis that addition of Sigh to pressure support ventilation (PSV, the most common assisted mechanical ventilation mode) might decrease ventilation pressures and FiO2, and limit regional lung strain and stress through various synergic mechanisms potentially yielding decreased risk of VILI, faster weaning and improved clinical outcomes.
The investigators conceived a pilot RCT to verify clinical feasibility of the addition of Sigh to PSV in comparison to standard PSV.
The investigators will enrol 258 intubated spontaneously breathing patients with mild to moderate AHRF and ARDS admitted to the ICU.
Patients will be randomized through an online automatic centralized and computerized system to the following study groups (1:1 ratio):
- PSV group: will be treated by protective PSV settings until day 28 or death or performance of spontaneous breathing trial (SBT);
- PSV+Sigh group: will be treated by protective PSV settings with the addition of Sigh until day 28 or death or performance of spontaneous breathing trial (SBT).
Indications on ventilation settings, weaning, spontaneous breathing trial and rescue treatment will be specified.
|Condition or disease||Intervention/treatment||Phase|
|Respiratory Failure Acute Respiratory Distress Syndrome Ventilator Lung||Procedure: Sigh Procedure: Standard of care||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||258 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomised controlled trial, 2 groups, 1:1 randomisation|
|Masking:||None (Open Label)|
|Official Title:||PRessure suppOrT vEntilation + Sigh in aCuTe hypoxemIc respiratOry Failure patieNts (PROTECTION): a Pilot Randomized Controlled Trial|
|Estimated Study Start Date :||September 1, 2017|
|Estimated Primary Completion Date :||September 1, 2018|
|Estimated Study Completion Date :||September 1, 2019|
Active Comparator: PSV group
Will be treated by standard of care for patients undergoing assisted mechanical ventilation (e.g., protective PSV settings, protocolized weaning, etc.).
Procedure: Standard of care
Standard of care
Experimental: PSV+Sigh group
Will be treated by standard of care for patients undergoing assisted mechanical ventilation (e.g., protective PSV settings, protocolized weaning, etc.) + Sigh (short cyclic recruitment breath once every minute) until death or spontaneous breathing trial and extubation.
Application of cyclic pressure control breath delivered at 30 cmH2O for 3 seconds once per minute in patients undergoing pressure support ventilation
Other Name: Short cyclic recruitment breath
- Clinical feasibility of PSV+Sigh vs. standard of carde (PSV) [ Time Frame: 2 years ]
Feasibility will be assessed by measuring the number of patients in each group experiencing at least one of the following failure criteria:
- switch to controlled ventilation following presence of predefined criteria;
- use of PEEP ≥15 cmH2O, prone positioning, inhaled nitric oxide, extracorporeal membrane oxygenation;
- re-intubation within 48 hours from extubation following predefined criteria.
Based on previous data, the expected rate of failure in patients undergoing PSV will be 22% and we hypothesize a rate of 15% for patients in the PSV+Sigh group. Furthermore, we assume a non-inferiority of the treatment with PSV+Sigh, with a tolerance of 5%. Thus, a sample size of 258 patients (with 129 patients per study arm) will be sufficient to assess feasibility of the PSV+Sigh strategy in this pilot phase with power of 0.8 and alpha 0.05.
- Clinical safety of PSV+Sigh comparing adverse events between 2 groups [ Time Frame: 2 years ]
Compare incidence of the following adverse events in the 2 study groups:
- hemodynamic instability with hypotension (i.e., SBP <90 mmHg) despite vasoactive drugs;
- arrhythmias with heart rate <40 or >140 bpm;
- radiographic evidence of barotrauma (i.e., pneumothorax, pneumomediastinum, pneumatocoele, or subcutaneous emphysema);
- new chest tube placement.
- Quantification of the prevalence of Sigh responders [ Time Frame: 2 years ]Quantification of the prevalence of short- (i.e., within 30 minutes) and long-term (i.e., within 24 hours in the PSV+Sigh group) Sigh responders in respect to improved oxygenation.
- Mortality [ Time Frame: 2 years ]This analysis will be performed comparing the 2 study groups and in responders
- Ventilator-free days [ Time Frame: 2 years ]This analysis will be performed comparing the 2 study groups and in responders
- Number of days on assisted ventilation until day 28 [ Time Frame: 28 days ]This analysis will be performed comparing the 2 study groups and in responders
- Patients' comfort by visual analog scale [ Time Frame: 2 years ]This analysis will be performed comparing the 2 study groups and in responders
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03201263
|Contact: Tommaso Mauri, MDemail@example.com|
|Tiantan Hospital||Active, not recruiting|
|CHU Angers||Not yet recruiting|
|Contact: Alain Mercat|
|Principal Investigator: Alain Mercat|
|Sub-Investigator: Francois Beloncle|
|CHU Clermont-Ferrand||Active, not recruiting|
|Hospital de la croix rousse||Active, not recruiting|
|GH Sud Ile-de-France||Active, not recruiting|
|UNIVERSITÄTSKLINIKUM Schleswig-Holstein Campus Kiel||Active, not recruiting|
|General hospital of Larissa||Active, not recruiting|
|Ospedale di Catanzaro Pugliese Ciaccio||Active, not recruiting|
|Contact: Carlo Alberto Volta|
|Principal Investigator: Carlo A Volta|
|Sub-Investigator: Savino Spadaro|
|Ospedale San Martino||Active, not recruiting|
|Ospedale Maggiore Policlinico Cà Granda||Active, not recruiting|
|Milan, Italy, 20122|
|Istituto Clinico Humanitas||Active, not recruiting|
|Ospedale L. Sacco||Active, not recruiting|
|Ospedale Niguarda||Active, not recruiting|
|Ospedale San Gerardo||Active, not recruiting|
|Ospedale Gemelli||Active, not recruiting|
|Vall d'Hebron||Not yet recruiting|
|Contact: Oriol Roca|
|Principal Investigator: Oriol Roca|
|Sub-Investigator: M Garcia|
|Foundacion J Diaz||Active, not recruiting|
|Barking, Havering and Redbridge Hospital||Active, not recruiting|
|Romford, United Kingdom|
|Principal Investigator:||Tommaso Mauri, MD||Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy|
|Principal Investigator:||Laurent Brochard, MD||St Michael Hospital, Toronto, Canada|