Comparison of Two Different Types of Mechanical Ventilation Weaning in Patients in the ICU
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|ClinicalTrials.gov Identifier: NCT02122016|
Recruitment Status : Completed
First Posted : April 24, 2014
Last Update Posted : April 24, 2014
|Condition or disease||Intervention/treatment||Phase|
|Weaning Failure||Device: SmartCare Other: Conventional weaning protocol||Phase 4|
Background: Mechanical ventilation (MV) weaning is commonly performed using Spontaneous Breathing Trials (SBT) with pressure support ventilation after a daily weaning screen . Recently there has been an increased interest in automatic weaning trials, which consists of closed-loop ventilation, using ETCO2 monitoring during SBT [1, 2]. So far, there has been no clinical evidence to compare automatic weaning trials with those of SBT.
Objective: To compare MV weaning times between an Automatic Weaning Ventilation System (SmartCare/PS) and SBT groups.
Methods: A randomized, controlled study performed at a general ICU. Adult patients were enrolled who were ventilated for more than 24 hours. Tracheostomies patients, those with neurological conditions, and a Glasgow coma scales lower than 10 were excluded. Patients were randomized to either the control or Smart Care group. All patients were ventilated with a Drager Evita XL (Drager Medical, Lubeck, Germany) ventilator with SmartCare/PS software version 1.1 available for use immediately prior to randomization. The Control group consisted of a daily weaning screen and SBT with pressure support ventilation. If patients tolerated SBT, they were extubated. Smart Care group patients were also submitted to a daily weaning screen, after which they were ventilated with the SmartCare/PS mode. MV and weaning time, maximum inspiratory pressure (MIP), maximum expiratory pressure (MEP), vital capacity (VC), respiratory frequency to tidal volume ration (f/Vt), use of non-invasive ventilation (NIV) post extubation, and re-intubation rate we evaluated.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Weaning With Smartcare in Mechanically Ventilated Patients in the ICU - a Controlled and Randomized Study|
|Study Start Date :||June 2011|
|Actual Primary Completion Date :||April 2012|
|Actual Study Completion Date :||May 2012|
A computer driven weaning ventilator, using closed-loop ventilation, taking into account patients lung mechanics and exhaled CO2.
Ventilator with a SmartCare module that is capable of performing a computer-driven weaning trial taking into account patients lung mechanics and exaled CO2.
Active Comparator: Conventional weaning protocol
A conventional weaning protocol consisting of a daily weaning screen, which is performed by physiotherapist. All patients who are mechanically ventilated for more than 24 hours are given a spontaneous breathing trial.
Other: Conventional weaning protocol
A conventional weaning protocol performed by physiotherapist with a daily weaning screen and a spontaneous breathing trial
- Weaning time from mechanical ventilation [ Time Frame: From June 2011 to April 2012 an 11 month period ]The duration that patient's received mechanical ventilation until they were extubated comparing two weaning protocols (computer driven v daily weaning screen and spontaneous breathing trial).
- weaning success [ Time Frame: From June 2011 to April 2012 an 11 month period ]Evaluate the rate of weaning success of patients under mechanical ventilation. Success defined as patient not needing re-intubation up to 48 hours after extubation.
- re-intubation rate [ Time Frame: From June 2011 to April 2012 an 11 month period ]Evaluate the re-intubation rate of patients that were extubated.
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): NCT02122016
|Hospital Israelita Albert Einstein|
|São Paulo, SP, Brazil, 05652-900|
|Hospital Israelita Albert Einstein's Critically Ill Department|
|Sao Paulo, Brazil, 05652900|
|Principal Investigator:||Corinne Taniguchi, PhD||Hospital Israelita Albert Einstein|