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Comparison of Two Different Types of Mechanical Ventilation Weaning in Patients in the ICU

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. Identifier: NCT02122016
Recruitment Status : Completed
First Posted : April 24, 2014
Last Update Posted : April 24, 2014
Information provided by (Responsible Party):
Corinne Taniguchi, Hospital Israelita Albert Einstein

Brief Summary:
Mechanical ventilation is widely used for ICU patients as a lifesaving procedure. However, it is associated with several complications, such as ventilator-associated pneumonia and the increase of hospital morbidity and mortality. To avoid such complications, we need to wean these patients off the ventilator as soon as possible. This must however be done at the right time to avoid other complications, such as the need for re-intubation. For this reason, it is important to have a specific weaning protocol, which will reduce the time on mechanical ventilation, and avoiding the need for re-intubation and other complications. Recently, an argument has developed as to which weaning protocol would be more appropriated, and whether a computer driven weaning protocol could have better results than the conventional weaning protocols focusing on daily screening and daily interruption of sedation followed by a spontaneous breathing test. Our objective is to compare mechanical ventilation times, weaning success up to 48 hours after extubation, re-intubation rates between a group with computer driven weaning protocol (SmartCare) versus a weaning protocol with daily weaning screens and spontaneous breathing trials in ICU patients ventilated for more than 24 hours.

Condition or disease Intervention/treatment Phase
Weaning Failure Device: SmartCare Other: Conventional weaning protocol Phase 4

Detailed Description:

Background: Mechanical ventilation (MV) weaning is commonly performed using Spontaneous Breathing Trials (SBT) with pressure support ventilation after a daily weaning screen [1]. 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
Experimental: SmartCare
A computer driven weaning ventilator, using closed-loop ventilation, taking into account patients lung mechanics and exhaled CO2.
Device: SmartCare
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

Primary Outcome Measures :
  1. 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).

Secondary Outcome Measures :
  1. 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.

  2. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Recovery from the causes that had led to mechanical ventilation
  • Capacity to initiate a spontaneous breathing effort
  • Spontaneous eye opening and responsiveness even with low doses of sedation
  • Oxygen inspired fraction lower than 50% with oxygen pulse oximeter higher than 95%
  • Positive end-expiratory pressure under 10 cmH2O
  • Hemodynamic stability
  • Vasopressor drugs lower than 0.05mcg/ml/kg

Exclusion Criteria:

  • Tracheotomized patients
  • Neurological sequels with a poor prognostic (post cardiorespiratory arrest or central neurological injury)
  • Glasgow scale lower than 10

Information from the National Library of Medicine

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 identifier (NCT number): NCT02122016

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Hospital Israelita Albert Einstein
São Paulo, SP, Brazil, 05652-900
Hospital Israelita Albert Einstein's Critically Ill Department
Sao Paulo, Brazil, 05652900
Sponsors and Collaborators
Hospital Israelita Albert Einstein
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Principal Investigator: Corinne Taniguchi, PhD Hospital Israelita Albert Einstein
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Corinne Taniguchi, Physiotherapist, PhD, Hospital Israelita Albert Einstein Identifier: NCT02122016    
Other Study ID Numbers: SmartCare\HIAE11
First Posted: April 24, 2014    Key Record Dates
Last Update Posted: April 24, 2014
Last Verified: April 2014
Keywords provided by Corinne Taniguchi, Hospital Israelita Albert Einstein:
Ventilator weaning
Computer driven weaning
Decision Making, Computer-Assisted
Therapy, Computer-Assisted
Respiration, Artificial