Acute Mechanical Ventilatory FailureNCT01541462
Weaning From Prolonged Mechanical Ventilation
A study testing Weaning in people with Acute Mechanical Ventilatory Failure, run by RML Specialty Hospital at 1 site in United States.
Trial summary
Patients requiring the use of artificial ventilation (also called mechanical ventilation) for more than 21 days account for more than 37% of all ICU costs. As such, these patients are now transferred to centers that specialize in weaning patients from the respirator; these units are referred to as long-term acute care… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Mechanical Ventilatory Failure
- What is being tested?
- Weaning
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2000to Oct 2011
- Phase
- Interventional
- 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
- Mechanical Ventilation for at least 21 days
Who cannot join
- Hypoxemia (oxygen saturation < 90% with fractional inspired O2 concentration > 0.40, and positive end-expiratory pressure > 5 cm H2O
- Hemodynamic instability (requiring intravenous vasoactive agents, such as dopamine > 5 mg/kg/min)
- Profound neurological deficits (large stroke)
- Documented bilateral phrenic nerve injury
- Previous admission to RML Hospital
- Life expectancy less than 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Patients requiring the use of artificial ventilation (also called mechanical ventilation) for more than 21 days account for more than 37% of all ICU costs. As such, these patients are now transferred to centers that specialize in weaning patients from the respirator; these units are referred to as long-term acute care (LTAC) facilities. Despite the increase of LTAC facilities, research on the fastest method for disconnecting the patient from the respirator is lacking. In addition, little information is available regarding the long-term survival and quality of life after a prolonged course of artificial ventilation. The purpose of this study is to determine the fastest method for disconnecting the patient from the respirator at a LTAC facility and its effect on long-term survival and quality of life.
Read the detailed description
Patients requiring prolonged mechanical ventilation (defined as more than 21 days) account for more than 37% of all ICU costs. As such, these patients are now transferred to centers that specialize in weaning from mechanical ventilation, so called long-term acute care (LTAC) facilities. Despite the proliferation of LTAC facilities, research on methods for expediting weaning is lacking. In addition, little information is available regarding long-term survival and patient's perception of quality of life after a prolonged course of mechanical ventilation.
In patients receiving mechanical ventilation in an ICU, randomized trials have revealed that ventilator duration was significantly influenced by weaning methods. The two most common weaning methods are pressure support and spontaneous breathing trials. Unlike the ICU, the relative efficacy of these two techniques in weaning patients requiring prolonged ventilation at a LTAC facility is largely unknown. The aim of this proposal is to determine whether the length of time required for weaning from prolonged ventilation differs with pressure support versus spontaneous breathing trials. The second aim is to determine the long-term impact of prolonged ventilation on survival, functional status and quality of life.
- Conditions
- Acute Mechanical Ventilatory Failure
- Being tested
- Weaning
- Keywords
- mechanical ventilation, weaning, pressure support, spontaneous breathing, Long-term acute care facility, mortality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WeaningOther
Also called Pressure support, Spontaneous breathing
Decrease assistance provided by the ventilator
| Study group | Role | What they receive |
|---|---|---|
| Pressure support | Active comparator | Patients randomized to the pressure support arm will wean using pressure support ventilation. The level of pressure support will be decreased by 2 cm H2O every 6 hours. The maximum decrement in pressure support permitted in one day will be 6 cm H2O. Receives: Other: Weaning |
| Spontaneous Breathing | Active comparator | Patients randomized to spontaneous breathing arm will be disconnected from the ventilator and allowed to breathe spontaneously through the tracheostomy. Duration of the trial will be increased sequentially as tolerated. Receives: Other: Weaning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weaning duration
Measured: From the first day of randomization to the day the patient was successfully weaned up to 5 days
Secondary outcomes (1)
mortality
Measured: 6 and 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2012 (estimated)
- Study startOct 2000
- Primary completionJun 2010
- Study completionOct 2011
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 Acute Mechanical Ventilatory 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- RML Specialty Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Amal Jubran, RML Specialty Hospital
- Investigators
- Amal Jubran, MD, Principal investigator, RML Specialty Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01541462
- Sponsor's protocol ID
- AXJ001
- Other IDs
- 5R01NR008782
- Status last verified
- Feb 2012
- First submitted
- 16 Feb 2012
- Last updated
- 1 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Jubran A, Grant BJ, Duffner LA, Collins EG, Lanuza DM, Hoffman LA, Tobin MJ. Effect of pressure support vs unassisted breathing through a tracheostomy collar on weaning duration in patients requiring prolonged mechanical ventilation: a randomized trial. JAMA. 2013 Feb 20;309(7):671-7. doi: 10.1001/jama.2013.159.
PubMed 23340588
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weaning From Prolonged Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT01541462
- Acronym / sponsor ID
- AXJ001
- Conditions
- Acute Mechanical Ventilatory Failure
- Keywords
- mechanical ventilation, weaning, pressure support, spontaneous breathing, Long-term acute care facility, mortality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- RML Specialty HospitalUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- Oct 2000
- Primary completion
- Jun 2010 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 1 Mar 2012 (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.
Patients requiring the use of artificial ventilation (also called mechanical ventilation) for more than 21 days account for more than 37% of all ICU costs. As such, these patients are now transferred to centers that specialize in weaning patients from the respirator; these units are referred to as long-term acute care (LTAC) facilities. Despite the increase of LTAC facilities, research on the fastest method for disconnecting the patient from the respirator is lacking. In addition, little information is available regarding the long-term survival and quality of life after a prolonged course of artificial ventilation. The purpose of this study is to determine the fastest method for disconnecting the patient from the respirator at a LTAC facility and its effect on long-term survival and quality of life.
Detailed description
Patients requiring prolonged mechanical ventilation (defined as more than 21 days) account for more than 37% of all ICU costs. As such, these patients are now transferred to centers that specialize in weaning from mechanical ventilation, so called long-term acute care (LTAC) facilities. Despite the proliferation of LTAC facilities, research on methods for expediting weaning is lacking. In addition, little information is available regarding long-term survival and patient's perception of quality of life after a prolonged course of mechanical ventilation.
In patients receiving mechanical ventilation in an ICU, randomized trials have revealed that ventilator duration was significantly influenced by weaning methods. The two most common weaning methods are pressure support and spontaneous breathing trials. Unlike the ICU, the relative efficacy of these two techniques in weaning patients requiring prolonged ventilation at a LTAC facility is largely unknown. The aim of this proposal is to determine whether the length of time required for weaning from prolonged ventilation differs with pressure support versus spontaneous breathing trials. The second aim is to determine the long-term impact of prolonged ventilation on survival, functional status and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pressure support | Active comparator | Other: WeaningPatients randomized to the pressure support arm will wean using pressure support ventilation. The level of pressure support will be decreased by 2 cm H2O every 6 hours. The maximum decrement in pressure support permitted in one day will be 6 cm H2O. |
| Spontaneous Breathing | Active comparator | Other: WeaningPatients randomized to spontaneous breathing arm will be disconnected from the ventilator and allowed to breathe spontaneously through the tracheostomy. Duration of the trial will be increased sequentially as tolerated. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Mechanical Ventilation for at least 21 days
Key exclusion criteria (6 listed)
- Hypoxemia (oxygen saturation < 90% with fractional inspired O2 concentration > 0.40, and positive end-expiratory pressure > 5 cm H2O
- Hemodynamic instability (requiring intravenous vasoactive agents, such as dopamine > 5 mg/kg/min)
- Profound neurological deficits (large stroke)
- Documented bilateral phrenic nerve injury
- Previous admission to RML Hospital
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 |
|---|---|---|
| WeaningAlso: Pressure support, Spontaneous breathingDecrease assistance provided by the ventilator | Other | Pressure support, Spontaneous Breathing |
Primary outcome
Weaning duration
Time frame: From the first day of randomization to the day the patient was successfully weaned up to 5 days
1 secondary outcome
mortality
Time frame: 6 and 12 month
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 1 Mar 2012.
- Derived from this study: PubMed 23340588Jubran A, Grant BJ, Duffner LA, Collins EG, Lanuza DM, Hoffman LA, Tobin MJ. Effect of pressure support vs unassisted breathing through a tracheostomy collar on weaning duration in patients requiring prolonged mechanical ventilation: a randomized trial. JAMA. 2013 Feb 20;309(7):671-7. doi: 10.1001/jama.2013.159.
Related trials for Acute Mechanical Ventilatory Failure
Recruiting
Medical Device Clinical Trial Without CE Marking to Evidence Safety and Performance of the INBENTUS VERSATILE Ventilator in Patients Requiring Assisted/Controlled Mechanical Ventilation and Weaning.
Acute Respiratory Distress Syndrome (ARDS), Pneumonia
Recruiting
Targeting prEssure-Muscle-index to Avoid Ventilatory Over-Assistance During Pressure Support Ventilation
Acute Hypoxemic Respiratory Failure, Mechanical Ventilation Complication
Not yet recruiting
Evaluation of the Clinical and Prognostic Value of Non-invasive Analysis of Mandibular Movements (MM) as a Marker of Inspiratory Effort in the Spontaneously Breathing Intensive Care Patient
Acute Respiratory Failure (ARF), Intensive Care Unit (ICU) Patients
Active, not recruitingObservational study
Assessment of PaO2/FiO2 Ratio Pre and POst INTubation
Acute Hypoxemic Respiratory Failure
Recruiting
The Effects of Music Therapy on Adult Patients Requiring Mechanical Ventilation in the ICU
Acute Respiratory Distress Syndrome, Acute Hypoxemic Respiratory Failure
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.
Amal Jubran, MD principal investigator
RML Specialty Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weaning in people with Acute Mechanical Ventilatory Failure, run by RML Specialty Hospital 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 1 inclusion and 6 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 1 Mar 2012. 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?
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 duration (time frame: From the first day of randomization to the day the patient was successfully weaned up to 5 days). 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 NCT01541462, 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 1 Mar 2012.