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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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3 May 2021 |
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Main ID: |
NCT03201263 |
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Date of registration:
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19/06/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Sigh in Acute Hypoxemic Respiratory Failure
PROTECTION |
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Scientific title:
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PRessure suppOrT vEntilation + Sigh in aCuTe hypoxemIc respiratOry Failure patieNts (PROTECTION): a Pilot Randomized Controlled Trial |
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Date of first enrolment:
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December 20, 2017 |
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Target sample size:
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258 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03201263 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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China
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France
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Germany
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Greece
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Italy
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Spain
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United Kingdom
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Contacts
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Name:
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Tommaso Mauri, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy |
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Name:
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Laurent Brochard, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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St Michael Hospital, Toronto, Canada |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- patients intubated since >24 hours and =7 days,
- undergoing PSV since >4 and =24 hours,
- PaO2/FiO2 ratio =300 mmHg (measured at clinical positive end-expiratory pressure
[PEEP] and FiO2 values)
- clinical PEEP =5 cmH2O,
- Richmond Agitation-Sedation Scale (RASS) value of -2 to 0
Exclusion Criteria:
- patients with PEEP =15 cmH2O;
- PaCO2 >60 mmHg;
- Arterial pH <7.30;
- Age <18 year-old;
- PaO2/FiO2 ratio =100 mmHg (measured at clinical PEEP and FiO2 values);
- central nervous system or neuromuscular disorders;
- history of severe chronic obstructive pulmonary disease or fibrosis;
- AHRF fully explained by cardiac failure or fluid overload (e.g., left ventricle
ejection fraction =40% with no other risk factor);
- impossibility to titrate sedation to desired RASS value of -2 to 0;
- evidence of active air leak from the lung (e.g., pneumothorax);
- cardiovascular instability (e.g., systolic blood pressure [SBP] <90 mmHg despite
vasopressors);
- clinical suspect of elevated intracranial pressure;
- extracorporeal support;
- moribund status;
- refusal by the attending physician.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Ventilator Lung
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Respiratory Failure
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Acute Respiratory Distress Syndrome
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Intervention(s)
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Procedure: Sigh
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Procedure: Standard of care
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Primary Outcome(s)
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Clinical feasibility of PSV+Sigh vs. standard of carde (PSV)
[Time Frame: 2 years]
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Secondary Outcome(s)
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Mortality
[Time Frame: 2 years]
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Quantification of the prevalence of Sigh responders
[Time Frame: 2 years]
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Ventilator-free days
[Time Frame: 2 years]
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Number of days on assisted ventilation until day 28
[Time Frame: 28 days]
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Clinical safety of PSV+Sigh comparing adverse events between 2 groups
[Time Frame: 2 years]
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Patients' comfort by visual analog scale
[Time Frame: 2 years]
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Secondary ID(s)
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Sigh study
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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