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

NCT02122016 | Completed Phase 4

• 1 other identifier: SmartCare\HIAE11
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

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.

Conditions

Weaning Failure

Keywords

Ventilator weaning; Protocols; Computer driven weaning; Decision Making, Computer-Assisted; Therapy, Computer-Assisted; Respiration, Artificial

Outcome Measures

Primary Outcomes (1)

• Weaning time from mechanical ventilation

  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).

  From June 2011 to April 2012 an 11 month period

Secondary Outcomes (2)

• weaning success

  From June 2011 to April 2012 an 11 month period

• re-intubation rate

  From June 2011 to April 2012 an 11 month period

Study Arms (2)

SmartCare

EXPERIMENTAL

A computer driven weaning ventilator, using closed-loop ventilation, taking into account patients lung mechanics and exhaled CO2.

Device: SmartCare

Conventional weaning protocol

ACTIVE COMPARATOR

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

Interventions

SmartCare DEVICE

Ventilator with a SmartCare module that is capable of performing a computer-driven weaning trial taking into account patients lung mechanics and exaled CO2.

SmartCare

Conventional weaning protocol OTHER

A conventional weaning protocol performed by physiotherapist with a daily weaning screen and a spontaneous breathing trial

Conventional weaning protocol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hospital Israelita Albert Einstein: lead

Study Sites (2)

Hospital Israelita Albert Einstein

São Paulo, São Paulo, 05652-900, Brazil

Location

Hospital Israelita Albert Einstein's Critically Ill Department

São Paulo, São Paulo, 05652900, Brazil

Location

Related Publications (1)

• 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(1):246. doi: 10.1186/s13054-015-0978-6.

  PMID: 26580673 DERIVED

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Corinne Taniguchi, PhD

  Hospital Israelita Albert Einstein

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist, PhD

Study Record Dates

• First Submitted: August 27, 2013
• First Posted: April 24, 2014
• Study Start: June 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: May 1, 2012
• Last Updated: April 24, 2014

Record last verified: 2014-04

Locations

BR (2)