Respiration, ArtificialNCT00790725
Proportional Assist Ventilation vs Pressure Support Ventilation
A study testing Proportional Assist Ventilation and Pressure Support Ventilation in people with Respiration, Artificial, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
In this study, we want to compare two different kinds of artificial ventilation to see if one encourages faster weaning from breathing support and if one provides better sleep quality. These artificial ventilation types are: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiration, Artificial
- What is being tested?
- Proportional Assist Ventilation and Pressure Support Ventilation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to May 2010
- 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
- Tracheotomized or endotracheally intubated and mechanically ventilated patients transferred or scheduled to be transferred to the RACU.
- Age 18 years or older.
Who cannot join
- Patients who are weaned from ventilatory support within the first 72 hours of transfer to the RACU. Even though these patients had been randomized, they will be excluded. They will be considered in the intention to treat analysis but the final outcome analysis will be performed after their exclusion.
- High spinal cord injury
- Immunosuppressed patients receiving chemotherapy or radiation therapy (< 2 months after chemotherapy or radiation therapy).
- Neuromuscular/ neurological disease of a progressive nature resulting in chronic ventilator dependence.
- High risk of mortality within 3 months (severe neurological damage and cancer patients in terminal stages of the disease).
- Patients unable to trigger the ventilator for any reason.
Show all 9Show fewer
- Any patient who is not considered a candidate for weaning from ventilatory support
- Patients consented for another interventional study.
- Patients requiring more than 30 days to wean once randomized will be excluded. They will be considered in the intention to treat analysis but the final outcome analysis will be performed after their exclusion.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Proportional Assist Ventilation vs. Pressure Support Ventilation in the Management of Patients Referred to a Respiratory Acute Care Unit
In this study, we want to compare two different kinds of artificial ventilation to see if one encourages faster weaning from breathing support and if one provides better sleep quality. These artificial ventilation types are:
- Pressure support ventilation; the standard ventilation that we use for the patients in the Respiratory Acute Care Unit. Pressure support ventilation ventilators use constant air pressure to assist patients with their breathing.
- Proportional assist ventilation; a newer way of helping people with their breathing. The air pressure provided by proportional assist ventilation ventilators varies with the size of the breath that a person takes.
- Conditions
- Respiration, Artificial
- Being tested
- Proportional Assist Ventilation, Pressure Support Ventilation
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proportional Assist VentilationOther
Proportional Assist Ventilation will be used to ventilate the patients.
Pressure Support VentilationOther
Pressure Support ventilation will be used to ventilate the patients.
| Study group | Role | What they receive |
|---|---|---|
| PAV | Other | Proportional Assist Ventilation will be used as a mechanical ventilation method for randomized patients in RACU Receives: Other: Proportional Assist Ventilation |
| PS | Other | Pressure Support Ventilation will be used as a mechanical ventilation method for randomized patients in RACU Receives: Other: Pressure Support Ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of time mechanically ventilated in the RACU
Measured: 30 days
Secondary outcomes (6)
Sleep quality
Measured: 48 hours
Inflammatory mediator levels
Measured: 30 days
Hospital mortality
Measured: 30 days
60 day mortality
Measured: 60 days
180 day mortality
Measured: 180 days
365 day mortality
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2008 (estimated)
- Study startNov 2008
- Primary completionMay 2010
- Study completionMay 2010
Why it stopped: The patient population in RACU has changed significantly, we can not find potential subjects to recruit. The enrollment rate has reached zero.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiration, ArtificialStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic - MITG
- Responsible party
- Principal investigator, Robert M. Kacmarek, Massachusetts General Hospital
- Investigators
- Robert M Kacmarek, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00790725
- Sponsor's protocol ID
- 2008-P-001377
- Status last verified
- Apr 2012
- First submitted
- 11 Nov 2008
- Last updated
- 25 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proportional Assist Ventilation vs. Pressure Support Ventilation in the Management of Patients Referred to a Respiratory Acute Care Unit
- ClinicalTrials.gov ID
- NCT00790725
- Acronym / sponsor ID
- 2008-P-001377
- Conditions
- Respiration, Artificial
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The patient population in RACU has changed significantly, we can not find potential subjects to recruit. The enrollment rate has reached zero.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Medtronic - MITG
- Study start
- Nov 2008
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 13 Nov 2008 (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.
In this study, we want to compare two different kinds of artificial ventilation to see if one encourages faster weaning from breathing support and if one provides better sleep quality. These artificial ventilation types are:
- Pressure support ventilation; the standard ventilation that we use for the patients in the Respiratory Acute Care Unit. Pressure support ventilation ventilators use constant air pressure to assist patients with their breathing.
- Proportional assist ventilation; a newer way of helping people with their breathing. The air pressure provided by proportional assist ventilation ventilators varies with the size of the breath that a person takes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PAV | Other | Other: Proportional Assist VentilationProportional Assist Ventilation will be used as a mechanical ventilation method for randomized patients in RACU |
| PS | Other | Other: Pressure Support VentilationPressure Support Ventilation will be used as a mechanical ventilation method for randomized patients in RACU |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Tracheotomized or endotracheally intubated and mechanically ventilated patients transferred or scheduled to be transferred to the RACU.
- Age 18 years or older.
Key exclusion criteria (9 listed)
- Patients who are weaned from ventilatory support within the first 72 hours of transfer to the RACU. Even though these patients had been randomized, they will be excluded. They will be considered in the intention to treat analysis but the final outcome analysis will be performed after their exclusion.
- High spinal cord injury
- Immunosuppressed patients receiving chemotherapy or radiation therapy (< 2 months after chemotherapy or radiation therapy).
- Neuromuscular/ neurological disease of a progressive nature resulting in chronic ventilator dependence.
- High risk of mortality within 3 months (severe neurological damage and cancer patients in terminal stages of the disease).
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 |
|---|---|---|
| Proportional Assist VentilationProportional Assist Ventilation will be used to ventilate the patients. | Other | PAV |
| Pressure Support VentilationPressure Support ventilation will be used to ventilate the patients. | Other | PS |
Primary outcome
Length of time mechanically ventilated in the RACU
Time frame: 30 days
6 secondary outcomes
Sleep quality
Time frame: 48 hours
Inflammatory mediator levels
Time frame: 30 days
Hospital mortality
Time frame: 30 days
60 day mortality
Time frame: 60 days
180 day mortality
Time frame: 180 days
365 day mortality
Time frame: 1 year
Results and safety
The study was stopped early (reason given: The patient population in RACU has changed significantly, we can not find potential subjects to recruit. The enrollment rate has reached zero.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2012.
Related trials for Respiration, Artificial
Not yet recruiting
Miniature In-line Respirator
Brain Death, Respiration, Artificial
Recruiting
Manual T-piece Versus Ventilator Positive Pressure Ventilation During Resuscitation of Extremely Premature Neonates
Neonatal Resuscitation, Apnea Neonatal
RecruitingObservational study
PAH-SDB: Sleep-Disordered Breathing and Outcomes in Pulmonary Arterial Hypertension
Pulmonary Arterial Hypertension (PAH), Sleep-disordered Breathing (SDB)
Recruiting
Optimal Timing for Spontaneous Breathing Trials
Respiration, Artificial, Weaning
RecruitingObservational study
VENtilation Modalities During Transport of PostoperatIve CRITically Ill Patients to the ICU
Respiration, Artificial, Positive-Pressure Respiration
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.
Robert M Kacmarek, PhD principal investigator
Massachusetts General 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 Proportional Assist Ventilation and Pressure Support Ventilation in people with Respiration, Artificial, run by Massachusetts General 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 2 inclusion and 9 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 25 Apr 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 was stopped early (reason given: The patient population in RACU has changed significantly, we can not find potential subjects to recruit. The enrollment rate has reached zero.). Results are not available in the source record.
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?
Length of time mechanically ventilated in the RACU (time frame: 30 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 25 Apr 2012.