Respiratory InsufficiencyNCT00606554
Clinical Trial of a Computer-driven Weaning System for Patients Requiring Mechanical Ventilation
A study testing Computer-assisted weaning program in people with Respiratory Insufficiency, run by Boston Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to compare the efficacy of a computer-assisted ventilator weaning system (Drager Smartcare) to our current standard of care in the medical intensive care unit. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Insufficiency
- What is being tested?
- Computer-assisted weaning program
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to May 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Age greater than 18 years
- Initiated on mechanical ventilation via endotracheal tube
- Admitted to Medical Intensive Care Unit and Medical Intensive Care Unit Team (Harrison Avenue Campus, Menino Pavilion)
- Requiring mechanical ventilation for more than 48 hours
- Meets prespecified weaning criteria
Who cannot join
- Do Not Resuscitate/Do Not Intubate order
- Pregnancy
- Mechanical ventilation initiated at another hospital
- Cardiac arrest for more than 5 minutes with poor neurologic prognosis
- Tracheostomy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial of Computer-Driven Weaning Compared With Standard of Care Weaning in Medical Patients Requiring Mechanical Ventilation
The purpose of this study is to compare the efficacy of a computer-assisted ventilator weaning system (Drager Smartcare) to our current standard of care in the medical intensive care unit.
- Conditions
- Respiratory Insufficiency
- Being tested
- Computer-assisted weaning program, Standard of Care weaning
- Keywords
- Respiratory Insufficiency, Ventilators, Mechanical, Ventilator Weaning, Therapy, Computer-Assisted
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer-assisted weaning programDevice
Also called Drager Evita Smartcare System
Closed-loop, knowledge-based, computer-assisted wean program initiated at the start of ventilator weaning.
Standard of Care weaningBehavioural
Evidence-based standard of care weaning process.
| Study group | Role | What they receive |
|---|---|---|
| Computer-assisted weaning | Experimental | Group assigned to the computer-assisted weaning program Receives: Device: Computer-assisted weaning program |
| Standard of care weaning | Active comparator | Group assigned to receive current, evidence-based, standard of care for discontinuation of mechanical ventilation. Receives: Behavioral: Standard of Care weaning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of Weaning
Duration of weaning was assessed as the time from the initiation of weaning (randomization) to the time of successful extubation (defined as 48 hours free of mechanical ventilation). Patients were followed for the duration of hospitalization and the time of weaning onset and successful liberation from the ventilator was noted.
Measured: Continuous (median weaning duration was 2 days)
Secondary outcomes (7)
Duration of ICU Stay
Duration of ICU stay after weaning initiation
Measured: from start of weaning to discharge from ICU, on average 1-2 weeks
Duration of Mechanical Ventilation
Duration of mechanical ventilation from weaning initiation
Measured: from start of weaning to liberation from ventilator, on average 1-2 days
Duration of Hospitalization
Measured: from start of weaning to discharge from hospital, on average 1-2 weeks
Inpatient Mortality
proportion of patients in each arm who died in the hospital
Measured: 28 days
Sedation Requirements
measure was not recorded
Measured: during weaning, on average 1-2 days
Number of Spontaneous Breathing Trials Prior to Extubation
Measured: from start of weaning to liberation from ventilator, on average 1-2 days
Complications (Death During Wean, Ventilator-associated Pneumonia During Wean, Self Extubation, Re-intubation)
This outcome is a composite outcome of the total number of participants with any one of the above-listed weaning-associated complications.
Measured: Duration of weaning (median 2 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2008 (estimated)
- Study startJan 2008
- Primary completionMay 2010
- Study completionMay 2010
Why it stopped: Slow recruitment of subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Respiratory InsufficiencyStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christine C Reardon, MD, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00606554
- Sponsor's protocol ID
- H-26906
- Status last verified
- Nov 2017
- First submitted
- 3 Jan 2008
- Last updated
- 11 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Computer-Driven Weaning Compared With Standard of Care Weaning in Medical Patients Requiring Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT00606554
- Acronym / sponsor ID
- H-26906
- Conditions
- Respiratory Insufficiency
- Keywords
- Respiratory Insufficiency, Ventilators, Mechanical, Ventilator Weaning, Therapy, Computer-Assisted
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow recruitment of subjects
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 4 Feb 2008 (estimated)
- Results
- Posted 17 Aug 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the efficacy of a computer-assisted ventilator weaning system (Drager Smartcare) to our current standard of care in the medical intensive care unit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Computer-assisted weaning | Experimental | Device: Computer-assisted weaning programGroup assigned to the computer-assisted weaning program |
| Standard of care weaning | Active comparator | Behavioral: Standard of Care weaningGroup assigned to receive current, evidence-based, standard of care for discontinuation of mechanical ventilation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age greater than 18 years
- Initiated on mechanical ventilation via endotracheal tube
- Admitted to Medical Intensive Care Unit and Medical Intensive Care Unit Team (Harrison Avenue Campus, Menino Pavilion)
- Requiring mechanical ventilation for more than 48 hours
- Meets prespecified weaning criteria
Key exclusion criteria (5 listed)
- Do Not Resuscitate/Do Not Intubate order
- Pregnancy
- Mechanical ventilation initiated at another hospital
- Cardiac arrest for more than 5 minutes with poor neurologic prognosis
- Tracheostomy
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 |
|---|---|---|
| Computer-assisted weaning programAlso: Drager Evita Smartcare SystemClosed-loop, knowledge-based, computer-assisted wean program initiated at the start of ventilator weaning. | Device | Computer-assisted weaning |
| Standard of Care weaningEvidence-based standard of care weaning process. | Behavioural | Standard of care weaning |
Primary outcome
Duration of Weaning
Time frame: Continuous (median weaning duration was 2 days)
Duration of weaning was assessed as the time from the initiation of weaning (randomization) to the time of successful extubation (defined as 48 hours free of mechanical ventilation). Patients were followed for the duration of hospitalization and the time of weaning onset and successful liberation from the ventilator was noted.
7 secondary outcomes
Duration of ICU Stay
Time frame: from start of weaning to discharge from ICU, on average 1-2 weeks
Duration of Mechanical Ventilation
Time frame: from start of weaning to liberation from ventilator, on average 1-2 days
Duration of Hospitalization
Time frame: from start of weaning to discharge from hospital, on average 1-2 weeks
Inpatient Mortality
Time frame: 28 days
Sedation Requirements
Time frame: during weaning, on average 1-2 days
Number of Spontaneous Breathing Trials Prior to Extubation
Time frame: from start of weaning to liberation from ventilator, on average 1-2 days
Complications (Death During Wean, Ventilator-associated Pneumonia During Wean, Self Extubation, Re-intubation)
Time frame: Duration of weaning (median 2 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BUMC Pulmonary Center Home PageLink provided by the sponsor.
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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.
Christine C Reardon, MD principal investigator
Boston University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computer-assisted weaning program in people with Respiratory Insufficiency, run by Boston Medical Center at 1 site in United States.
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 5 inclusion and 5 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: stopped early, as of the sponsor's last update on 11 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Aug 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Duration of Weaning (time frame: Continuous (median weaning duration was 2 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Dec 2017.