NCT03018483UnknownNot Applicable
Comparison Between Automated Pressure Support Ventilation, Variable Pressure Support Ventilation and Non-variable Pressure Support Ventilation in Weaning From Mechanical Ventilation
Federico II University2 sites in 1 country342 target enrollmentStarted: May 1, 2017Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 342
- Locations
- 2
- Primary Endpoint
- weaning time
Study Overview
Brief Summary
The aim of this multicenter, randomized controlled trial is to evaluate the weaning time from mechanical ventilation comparing non-variable PSV, variable PSV, and Smart CareTM.
This study is a multicenter randomized controlled open trial comparing variable, non-variable pressure support ventilation and Smart CareTM in patients receiving mechanical ventilation for more than 24 hours who are able to be weaned.
The aim of the study is to determine the duration of weaning from mechanical ventilation for each one of the above mentioned weaning methods
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •age≥18 years
- •duration of controlled mechanical ventilation≥ 24 h
- •temperature≤ 39°C
- •hemoglobin≥ 6 g/dl
- •ratio of arterial partial pressure of oxygen to inspiratory oxygen fraction - PaO2/FiO2≥150mmHg with positive end-expiratory pressure (PEEP)≤ 16 cmH2O
- •ability of the patient to breathe spontaneously
- •informed consent
Exclusion Criteria
- •patient participated in another interventional trial within the last four weeks before enrollment
- •peripheral neurological disease associated with impairment of the respiratory pump
- •muscular disease associated with impairment of the respiratory pump
- •unstable thorax with paradoxical chest wall movement
- •planned surgery under general anesthesia within 72 hours
- •difficult airway or intubation
- •existing tracheotomy at ICU admission
- •expected survival<72 hours
- •home mechanical ventilation or on chronic oxygen therapy
- •suspected or confirmed pregnancy
Outcomes
Primary Outcomes
weaning time
Time Frame: within 6 hours
weaning time defined as the time from randomization to successful extubation.
Secondary Outcomes
No secondary outcomes reported
Investigators
Maria Vargas
Resercher
Federico II University
Study Sites (2)
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