Weaning Mode ComparisonNCT02773433
PAV vs Assist Control After Failed SBT
A study testing Proportional Assist Ventilation in people with Weaning Mode Comparison, run by University of Louisville at 1 site in United States.
Trial summary
The primary aim of this research is to determine the feasibility of conducting a randomized controlled trial comparing two ventilation modes in patients admitted to the ICU who require mechanical ventilation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Weaning Mode Comparison
- What is being tested?
- Proportional Assist Ventilation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to Nov 2016
- 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
- Age >18 yrs old
- Patient or proxy available in the hospital to consent
- Receipt of invasive mechanical ventilation on low ventilator support (Po2/Fio2 ratio >200, Fio2 <60% \& PEEP <8) for a period not greater than 48 hrs
Who cannot join
- Pregnant patients
- Terminal diseases (e.g. advanced or metastatic malignancy, liver cirrhosis with an estimated 3 month mortality > 50%)
- Severely depressed respiratory drive
- Receipt of neuromuscular blocker
- Bronchopleural fistula
- Inability to obtain consent from patients or their proxies.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Proportional Assist Ventilation Versus Volume-Assist-Control After a Failed Spontaneous Breathing Trial: a Randomized Controlled Trial
The primary aim of this research is to determine the feasibility of conducting a randomized controlled trial comparing two ventilation modes in patients admitted to the ICU who require mechanical ventilation. The investigators plan to include patients on mechanical ventilation with low support (PaO2/FiO2 ratio > 200, FiO2 < 0.5 and PEEP < 8) for a period no longer than 48 hrs. There are a number of potential barriers to enroll patients in the study. Importantly patients will have to be enrolled within 48 hours from the time they meet inclusion criteria.
The secondary aims are to determine the impact of proportional assist-ventilation (PAV) versus volume assist-control (VAC) ventilation by evaluating the number of ventilation-free days, development of Intensive Care Unit (ICU) delirium, use of sedative/ analgesic medications, use of antipsychotic medications, length of stay in the intensive care unit and hospital, reintubations within 24 hours, adverse events, and mortality in the two groups of patients.
Read the detailed description
Overview of Design Randomized controlled pilot study comparing mechanical ventilation modes and daily spontaneous trial combination, in patients requiring invasive mechanical ventilation with low ventilator support (PaO2/Fio2 ratio > 200, FiO2 < 0.5 \& PEEP <8) for a period not greater than 48 hrs.
Hypothesis The investigators hypothesize that 50 % of patients approached will agree to enrollment in this clinical trial over a period of 4 months. The investigators hypothesize 80% of the patients meeting inclusion criteria will be approached in a timely manner. The investigators also propose that PAV mode ventilation will be superior to ACV based on clinical outcome measurements.
Study Subjects Consecutive adult patients requiring invasive mechanical ventilation on low ventilator support (as mentioned above) for a period not greater than 48 hrs will be enrolled if they or their proxy consent for the study. The study will be performed in the intensive care units of University of Louisville and Jewish Hospital in Louisville, KY.
- Conditions
- Weaning Mode Comparison
- Being tested
- Proportional Assist Ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proportional Assist VentilationOther
Also called PAV
| Study group | Role | What they receive |
|---|---|---|
| PAV group | Experimental | Using Proportional Assist Ventilation after failed Spontaneous Breathing Trial Receives: Other: Proportional Assist Ventilation |
| Control group | No intervention | Using Volume Assist Control mode after failed SBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of patients who meet criteria for enrollment who are approached in a timely manner
Measured: 1 year
patient enrollment number over time
Measured: 1 year
compliance with the ventilator settings
Measured: 1 year
Secondary outcomes (9)
Ventilation free days from the time patient is enrolled in the study
Measured: 1 year
Development of ICU delirium Based on CAM ICU
Measured: 1 year
Use of sedative or analgesic medications
Measured: 1 year
Use of antipsychotic medications
Measured: 1 year
Reintubations within 24 hrs
Measured: 1 year
Length of stay in the intensive care unit
Measured: 1 year
Length of stay in the hospital
Measured: 1 year
Adverse events
Measured: 1 year
In hospital 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 posted16 May 2016 (estimated)
- Study startJan 2016
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weaning Mode ComparisonStudies 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
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rodrigo Cavallazzi, University of Louisville
- Investigators
- Rodrigo Cavallazzi, MD, Principal investigator, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02773433
- Sponsor's protocol ID
- 14.1009
- Status last verified
- Dec 2016
- First submitted
- 12 May 2016
- Last updated
- 7 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proportional Assist Ventilation Versus Volume-Assist-Control After a Failed Spontaneous Breathing Trial: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02773433
- Acronym / sponsor ID
- 14.1009
- Conditions
- Weaning Mode Comparison
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 16 May 2016 (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.
The primary aim of this research is to determine the feasibility of conducting a randomized controlled trial comparing two ventilation modes in patients admitted to the ICU who require mechanical ventilation. The investigators plan to include patients on mechanical ventilation with low support (PaO2/FiO2 ratio > 200, FiO2 < 0.5 and PEEP < 8) for a period no longer than 48 hrs. There are a number of potential barriers to enroll patients in the study. Importantly patients will have to be enrolled within 48 hours from the time they meet inclusion criteria.
The secondary aims are to determine the impact of proportional assist-ventilation (PAV) versus volume assist-control (VAC) ventilation by evaluating the number of ventilation-free days, development of Intensive Care Unit (ICU) delirium, use of sedative/ analgesic medications, use of antipsychotic medications, length of stay in the intensive care unit and hospital, reintubations within 24 hours, adverse events, and mortality in the two groups of patients.
Detailed description
Overview of Design Randomized controlled pilot study comparing mechanical ventilation modes and daily spontaneous trial combination, in patients requiring invasive mechanical ventilation with low ventilator support (PaO2/Fio2 ratio > 200, FiO2 < 0.5 \& PEEP <8) for a period not greater than 48 hrs.
Hypothesis The investigators hypothesize that 50 % of patients approached will agree to enrollment in this clinical trial over a period of 4 months. The investigators hypothesize 80% of the patients meeting inclusion criteria will be approached in a timely manner. The investigators also propose that PAV mode ventilation will be superior to ACV based on clinical outcome measurements.
Study Subjects Consecutive adult patients requiring invasive mechanical ventilation on low ventilator support (as mentioned above) for a period not greater than 48 hrs will be enrolled if they or their proxy consent for the study. The study will be performed in the intensive care units of University of Louisville and Jewish Hospital in Louisville, KY.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PAV group | Experimental | Other: Proportional Assist VentilationUsing Proportional Assist Ventilation after failed Spontaneous Breathing Trial |
| Control group | No intervention | –Using Volume Assist Control mode after failed SBT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age >18 yrs old
- Patient or proxy available in the hospital to consent
- Receipt of invasive mechanical ventilation on low ventilator support (Po2/Fio2 ratio >200, Fio2 <60% \& PEEP <8) for a period not greater than 48 hrs
Key exclusion criteria (6 listed)
- Pregnant patients
- Terminal diseases (e.g. advanced or metastatic malignancy, liver cirrhosis with an estimated 3 month mortality > 50%)
- Severely depressed respiratory drive
- Receipt of neuromuscular blocker
- Bronchopleural fistula
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 VentilationAlso: PAV | Other | PAV group |
Primary outcome
proportion of patients who meet criteria for enrollment who are approached in a timely manner
Time frame: 1 year
patient enrollment number over time
Time frame: 1 year
compliance with the ventilator settings
Time frame: 1 year
9 secondary outcomes
Ventilation free days from the time patient is enrolled in the study
Time frame: 1 year
Development of ICU delirium Based on CAM ICU
Time frame: 1 year
Use of sedative or analgesic medications
Time frame: 1 year
Use of antipsychotic medications
Time frame: 1 year
Reintubations within 24 hrs
Time frame: 1 year
Length of stay in the intensive care unit
Time frame: 1 year
Length of stay in the hospital
Time frame: 1 year
Adverse events
Time frame: 1 year
In hospital mortality
Time frame: 1 year
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 7 Dec 2016.
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.
Rodrigo Cavallazzi, MD principal investigator
University of Louisville
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 in people with Weaning Mode Comparison, run by University of Louisville 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 3 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 7 Dec 2016. 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?
proportion of patients who meet criteria for enrollment who are approached in a timely manner (time frame: 1 year). The study lists 3 primary outcomes in all. 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 7 Dec 2016.