Weaning FailurePhase 4NCT02122016
Comparison of Two Different Types of Mechanical Ventilation Weaning in Patients in the ICU
A Phase 4 study testing SmartCare and Conventional weaning protocol in people with Weaning Failure, run by Hospital Israelita Albert Einstein at 2 sites in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Weaning Failure
- What is being tested?
- SmartCare and Conventional weaning protocol
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 2 sitesBrazil
- Study dates
- Jun 2011to May 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Tracheotomized patients
- Neurological sequels with a poor prognostic (post cardiorespiratory arrest or central neurological injury)
- Glasgow scale lower than 10
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Hospital Israelita Albert Einstein
São Paulo, São Paulo, 05652-900
Hospital Israelita Albert Einstein's Critically Ill Department
São Paulo, São Paulo, 05652900
About this study
Official title: Weaning With Smartcare in Mechanically Ventilated Patients in the ICU - a Controlled and Randomized Study
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.
Read the 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.
- Conditions
- Weaning Failure
- Being tested
- SmartCare, Conventional weaning protocol
- Keywords
- Ventilator weaning, Protocols, Computer driven weaning, Decision Making, Computer-Assisted, Therapy, Computer-Assisted, Respiration, Artificial
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SmartCareDevice
Ventilator with a SmartCare module that is capable of performing a computer-driven weaning trial taking into account patients lung mechanics and exaled CO2.
Conventional weaning protocolOther
A conventional weaning protocol performed by physiotherapist with a daily weaning screen and a spontaneous breathing trial
| Study group | Role | What they receive |
|---|---|---|
| SmartCare | Experimental | A computer driven weaning ventilator, using closed-loop ventilation, taking into account patients lung mechanics and exhaled CO2. Receives: 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. Receives: Other: Conventional weaning protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From June 2011 to April 2012 an 11 month period
Secondary outcomes (2)
weaning success
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.
Measured: From June 2011 to April 2012 an 11 month period
re-intubation rate
Evaluate the re-intubation rate of patients that were extubated.
Measured: From June 2011 to April 2012 an 11 month period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2014 (estimated)
- Study startJun 2011
- Primary completionApr 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Weaning FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Israelita Albert Einstein
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Corinne Taniguchi, Hospital Israelita Albert Einstein
- Investigators
- Corinne Taniguchi, PhD, Principal investigator, Hospital Israelita Albert Einstein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02122016
- Sponsor's protocol ID
- SmartCare\HIAE11
- Status last verified
- Apr 2014
- First submitted
- 27 Aug 2013
- Last updated
- 24 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
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(1):246. doi: 10.1186/s13054-015-0978-6.
PubMed 26580673
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weaning With Smartcare in Mechanically Ventilated Patients in the ICU - a Controlled and Randomized Study
- ClinicalTrials.gov ID
- NCT02122016
- Acronym / sponsor ID
- SmartCare\HIAE11
- Conditions
- Weaning Failure
- Keywords
- Ventilator weaning, Protocols, Computer driven weaning, Decision Making, Computer-Assisted, Therapy, Computer-Assisted, Respiration, Artificial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Hospital Israelita Albert EinsteinUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 24 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SmartCare | Experimental | Device: SmartCareA computer driven weaning ventilator, using closed-loop ventilation, taking into account patients lung mechanics and exhaled CO2. |
| Conventional weaning protocol | Active comparator | Other: Conventional weaning protocolA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- Tracheotomized patients
- Neurological sequels with a poor prognostic (post cardiorespiratory arrest or central neurological injury)
- Glasgow scale lower than 10
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SmartCareVentilator with a SmartCare module that is capable of performing a computer-driven weaning trial taking into account patients lung mechanics and exaled CO2. | Device | SmartCare |
| Conventional weaning protocolA conventional weaning protocol performed by physiotherapist with a daily weaning screen and a spontaneous breathing trial | Other | Conventional weaning protocol |
Primary outcome
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).
2 secondary outcomes
weaning success
Time frame: From June 2011 to April 2012 an 11 month period
re-intubation rate
Time frame: From June 2011 to April 2012 an 11 month period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2014.
- Derived from this study: PubMed 26580673Taniguchi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Corinne Taniguchi, PhD principal investigator
Hospital Israelita Albert Einstein
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing SmartCare and Conventional weaning protocol in people with Weaning Failure, run by Hospital Israelita Albert Einstein at 2 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weaning time from mechanical ventilation (time frame: From June 2011 to April 2012 an 11 month period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02122016, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2014.