Respiratory FailureNCT00400881
Comparison Between Two Methods of Spontaneous Breathing Trial (SBT)
A study testing automatic tube compensation in people with Respiratory Failure, run by Texas Tech University Health Sciences Center, El Paso at 1 site in United States.
Trial summary
To compare a new mode of mechanical ventilation, Automatic Tube Compensation (ATC) with a traditional one, Continuous Positive Airway Pressure(CPAP), on its effectiveness for detecting patients no longer needing mechanical ventilation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Failure
- What is being tested?
- automatic tube compensation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Jan 2011
- 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
- patients 18 years of age or older
- on mechanical ventilation at Thomason Hospital Intensive Care Unit for more than 24 hours
- about to undergo SBT by the current institutional protocol for weaning assessment ordered by their treating physician
- availability of informed consent from patient or next of kin
Who cannot join
- patients for whom a decision has been made not to reinstitute ventilatory assistance under any circumstance
- pregnancy
- patients not considered for discontinuation of mechanical ventilation on the day of SBT
Trial locations and contacts
1 site in 1 country.
United States1 site
University Medical Center Hospital
El Paso, Texas, 79905
About this study
To compare a new mode of mechanical ventilation, Automatic Tube Compensation (ATC) with a traditional one, Continuous Positive Airway Pressure(CPAP), on its effectiveness for detecting patients no longer needing mechanical ventilation.
Read the detailed description
The ultimate goal of this proposal is to find the best way to rapidly and safely discontinue mechanical ventilation in patients recovering from respiratory failure.
It is common practice in these patients to perform trials of "spontaneous" breathing while still connected to the ventilator in order to assess their readiness to breathe without assistance. To help with this assessment, new mechanical modes have been incorporated to modern ventilators. A recently developed mode, called Automatic Tube Compensation, is designed for this purpose ("spontaneous" breathing). Whether this method is superior to traditional ones has not been established and the investigators intend to address this question.
The investigators aim to:
- compare Automatic Tube Compensation vs. our traditional mode (Continuous Positive Airway Pressure) during spontaneous breathing trials in their efficacy to identify patients ready be successfully removed from mechanical ventilation
- study which physiologic variables better predict successful discontinuation of mechanical ventilation in these two modes.
The investigators plan to prospectively randomize patients on mechanical ventilation at the point of weaning evaluation, to undergo spontaneous breathing trials with our current ventilatory mode (Continuous Positive Airway Pressure) or the new mode (Automatic Tube Compensation). Based on predefined physiologic and clinical variables, clinicians will decide whether patients are ready to be removed from mechanical ventilation. The proportions of successful discontinuation (no need to reinstitute mechanical ventilation) and the duration of the weaning period in both groups will be compared. During the spontaneous breathing trials, respiratory variables will be measured and compared between patients with successful vs. non successful discontinuation in order to evaluate their predictive value for successful outcome.
Mechanical ventilation is being used increasingly given our growing population with advanced age and multiple co morbidities and the rising volume of aggressive medical procedures. It is well known to be associated with medical complications and high health care costs. Reducing the duration of unnecessary mechanical ventilation while minimizing the risk of premature removal of needed assistance is the final objective of this project. Approaching this goal will decrease the adverse effects of this treatment and the cost of critical care.
- Conditions
- Respiratory Failure
- Being tested
- automatic tube compensation
- Keywords
- mechanical ventilation, weaning, respiratory failure, spontaneous breathing trial
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
automatic tube compensationOther
new mode of ventilation during spontaneous breathing trial. It is a mode of the same device (mechanical ventilator) where the pressure applied by the ventilator varies according to calculations o fthe mechanical properties of the respiratory system automatically performed by the ventilator.
| Study group | Role | What they receive |
|---|---|---|
| Continuous PAP (CPAP) | No intervention | CPAP (continuous positive airway pressure). 5 cm H2O. |
| Automatic tube compensation (ATC) | Experimental | ATC is a new mode of ventilation being compared with traditional one (CPAP). ATC is a mode of ventilation of the same device (mechanical ventilator), not a new device. The pressure in this modes varies according the mechanical parameters of the respiratory system that are automatically calculated by this mode. This is the intervention arm. Receives: Other: automatic tube compensation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of Weaning Time
Weaning time was determined as number of days from the day of the first SBT(spontaneous breathing trial) to the day of extubation. All patients were followed until extubation.
Measured: days
Secondary outcomes (1)
Duration of Mechanical Ventilation
Duration in days from day of intubation to day of extubation.
Measured: days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2006 (estimated)
- Study startJan 2007
- Primary completionJan 2011
- Study completionJan 2011
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 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Tech University Health Sciences Center, El Paso
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan B. Figueroa-Casas, Texas Tech University Health Sciences Center, El Paso
- Investigators
- Juan B Figueroa-Casas, MD, Principal investigator, Assistant Professor, Texas Tech University HSC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00400881
- Sponsor's protocol ID
- E06040
- Status last verified
- May 2017
- First submitted
- 16 Nov 2006
- Last updated
- 9 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Two Methods of Spontaneous Breathing Trial (SBT)
- ClinicalTrials.gov ID
- NCT00400881
- Acronym / sponsor ID
- E06040
- Conditions
- Respiratory Failure
- Keywords
- mechanical ventilation, weaning, respiratory failure, spontaneous breathing trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Texas Tech University Health Sciences Center, El PasoUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 17 Nov 2006 (estimated)
- Results
- Posted 17 May 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare a new mode of mechanical ventilation, Automatic Tube Compensation (ATC) with a traditional one, Continuous Positive Airway Pressure(CPAP), on its effectiveness for detecting patients no longer needing mechanical ventilation.
Detailed description
The ultimate goal of this proposal is to find the best way to rapidly and safely discontinue mechanical ventilation in patients recovering from respiratory failure.
It is common practice in these patients to perform trials of "spontaneous" breathing while still connected to the ventilator in order to assess their readiness to breathe without assistance. To help with this assessment, new mechanical modes have been incorporated to modern ventilators. A recently developed mode, called Automatic Tube Compensation, is designed for this purpose ("spontaneous" breathing). Whether this method is superior to traditional ones has not been established and the investigators intend to address this question.
The investigators aim to:
- compare Automatic Tube Compensation vs. our traditional mode (Continuous Positive Airway Pressure) during spontaneous breathing trials in their efficacy to identify patients ready be successfully removed from mechanical ventilation
- study which physiologic variables better predict successful discontinuation of mechanical ventilation in these two modes.
The investigators plan to prospectively randomize patients on mechanical ventilation at the point of weaning evaluation, to undergo spontaneous breathing trials with our current ventilatory mode (Continuous Positive Airway Pressure) or the new mode (Automatic Tube Compensation). Based on predefined physiologic and clinical variables, clinicians will decide whether patients are ready to be removed from mechanical ventilation. The proportions of successful discontinuation (no need to reinstitute mechanical ventilation) and the duration of the weaning period in both groups will be compared. During the spontaneous breathing trials, respiratory variables will be measured and compared between patients with successful vs. non successful discontinuation in order to evaluate their predictive value for successful outcome.
Mechanical ventilation is being used increasingly given our growing population with advanced age and multiple co morbidities and the rising volume of aggressive medical procedures. It is well known to be associated with medical complications and high health care costs. Reducing the duration of unnecessary mechanical ventilation while minimizing the risk of premature removal of needed assistance is the final objective of this project. Approaching this goal will decrease the adverse effects of this treatment and the cost of critical care.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous PAP (CPAP) | No intervention | –CPAP (continuous positive airway pressure). 5 cm H2O. |
| Automatic tube compensation (ATC) | Experimental | Other: automatic tube compensationATC is a new mode of ventilation being compared with traditional one (CPAP). ATC is a mode of ventilation of the same device (mechanical ventilator), not a new device. The pressure in this modes varies according the mechanical parameters of the respiratory system that are automatically calculated by this mode. This is the intervention arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients 18 years of age or older
- on mechanical ventilation at Thomason Hospital Intensive Care Unit for more than 24 hours
- about to undergo SBT by the current institutional protocol for weaning assessment ordered by their treating physician
- availability of informed consent from patient or next of kin
Key exclusion criteria (3 listed)
- patients for whom a decision has been made not to reinstitute ventilatory assistance under any circumstance
- pregnancy
- patients not considered for discontinuation of mechanical ventilation on the day of SBT
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 |
|---|---|---|
| automatic tube compensationnew mode of ventilation during spontaneous breathing trial. It is a mode of the same device (mechanical ventilator) where the pressure applied by the ventilator varies according to calculations o fthe mechanical properties of the respiratory system automatically performed by the ventilator. | Other | Automatic tube compensation (ATC) |
Primary outcome
Duration of Weaning Time
Time frame: days
Weaning time was determined as number of days from the day of the first SBT(spontaneous breathing trial) to the day of extubation. All patients were followed until extubation.
1 secondary outcome
Duration of Mechanical Ventilation
Time frame: days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Respiratory Failure
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Not yet recruiting
Regional Lung Ventilation During Prone Position in in Intubated Children
Pediatric Acute Respiratory Failure
Not yet recruiting
Smartphone Camera Measurement of Breathing-Related Heart Rate Variability Compared With ECG in Healthy Adults
Respiratory Sinus Arrhythmia, Heart Rate Variability
Not yet recruiting
Mechanical Ventilator Adjustments and Patient Dyspnea
Respiratory Failure, Dyspnea During Mechanical Ventilation
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
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.
Juan B Figueroa-Casas, MD principal investigator
Assistant Professor, Texas Tech University HSC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing automatic tube compensation in people with Respiratory Failure, run by Texas Tech University Health Sciences Center, El Paso 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 4 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 9 Jun 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 May 2012). 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 (time frame: 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 9 Jun 2017.