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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
Sponsor:
Information provided by (Responsible Party):
Corinne Taniguchi, Hospital Israelita Albert Einstein

Tracking Information
First Submitted Date  ICMJE August 27, 2013
First Posted Date  ICMJE April 24, 2014
Last Update Posted Date April 24, 2014
Study Start Date  ICMJE June 2011
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 22, 2014)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 22, 2014)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Two Different Types of Mechanical Ventilation Weaning in Patients in the ICU
Official Title  ICMJE Weaning With Smartcare in Mechanically Ventilated Patients in the ICU - a Controlled and Randomized Study
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Weaning Failure
Intervention  ICMJE
  • 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.
  • Other: Conventional weaning protocol
    A conventional weaning protocol performed by physiotherapist with a daily weaning screen and a spontaneous breathing trial
Study Arms  ICMJE
  • Experimental: SmartCare
    A computer driven weaning ventilator, using closed-loop ventilation, taking into account patients lung mechanics and exhaled CO2.
    Intervention: Device: SmartCare
  • 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.
    Intervention: Other: Conventional weaning protocol
Publications * Taniguchi C, Victor ES, Pieri T, Henn R, Santana C, Giovanetti E, Saghabi C, Timenetsky K, Caserta Eid R, Silva E, Matos GF, Schettino GP, Barbas CS. Smart Care™ versus respiratory physiotherapy-driven manual weaning for critically ill adult patients: a randomized controlled trial. Crit Care. 2015 Jun 11;19:246. doi: 10.1186/s13054-015-0978-6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 22, 2014)
70
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2012
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02122016
Other Study ID Numbers  ICMJE SmartCare\HIAE11
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Corinne Taniguchi, Hospital Israelita Albert Einstein
Study Sponsor  ICMJE Hospital Israelita Albert Einstein
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Corinne Taniguchi, PhD Hospital Israelita Albert Einstein
PRS Account Hospital Israelita Albert Einstein
Verification Date April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP