Respiratory FailureNCT01810510
Impact of PAV Versus NAVA on Patient-Ventilator Synchrony and Respiratory Muscle Unloading
A study testing PAV Ventilation and NAVA Ventilation in people with Respiratory Failure, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The purpose of this study is to determine whether two modes of artificial (i.e. mechanical) ventilation have an impact on patient synchrony with the ventilator (breathing machine) and on the patient's work of breathing. 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?
- PAV Ventilation and NAVA Ventilation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Sep 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 years or older
- Respiratory failure requiring mechanical ventilation
- Spontaneously breathing (able to generate flow/ pressure/ volume triggers on control modes of ventilation or on a mode of mechanically assisted spontaneous breathing)
- Requiring FiO2< 60% and PEEP< 10cm H2O to maintain oxygen saturations >90%
Who cannot join
- Pregnancy
- Inability to tolerate spontaneous breathing
- Gastro-esophageal pathology (including but not limited to recent gastric or esophageal surgery, history of varices, known anatomical gastric or esophageal defects such as strictures, hernias or fistulas)
- Agitation necessitating major sedative infusions
- Hemodynamic instability necessitating active adjustments in vasopressor therapy
- Coagulopathy
- New intracranial pathology (stroke, hemorrhage, meningitis, encephalitis)
- Paralyzed diaphragm
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
The purpose of this study is to determine whether two modes of artificial (i.e. mechanical) ventilation have an impact on patient synchrony with the ventilator (breathing machine) and on the patient's work of breathing.
Read the detailed description
New, "intelligent" ventilator modes with more complex closed loops have been developed, some with a demonstrated clinical benefit. The modes of proportional assist ventilation (PAV) and neurally-adjusted ventilatory assist (NAVA) are capable of delivering ventilation proportional to patient effort and may be associated with improved patient-ventilator synchrony when compared to pressure support ventilation (PSV), a classic simple closed-loop assisted ventilation mode.
This study will study both modes of ventilation (PAV and NAVA) in each patient who is recruited, and measures of patient-ventilator synchrony and work of breathing will be taken during each mode.
Baseline data will be collected on a standardized volume-cycled control mode ventilator setting for 5 minutes and on a standardized pressure support ventilator mode for 25 minutes. Subjects will then be randomized to either PAV or NAVA ventilation and will be ventilated on that mode for 30 minutes. Equivalence of support levels between PAV and NAVA trials will be ensured by targeting the same peak (Ppeak) airway pressures. Data collected will include (but are not limited to) vital signs, sedation score, dyspnea assessment using visual analog scale, respiratory rate, tidal volume (Vt), peak airway pressure (Ppeak), inspiratory time and neural inspiratory time (Ti and Tni), total physiologic and neural respiratory cycle time (Ttot and Tntot), end-tidal CO2, esophageal pressure waveforms, waveforms of all ventilatory patterns, Edi waveforms, and peak Edi. Subjects will then be switched to the other mode of ventilation and undergo an identical 30-minute evaluation period with identical data collection. Arterial blood gas measurements will be done after any changes in ventilator settings only in subjects who have had arterial lines inserted for clinically-indicated reasons. This will be a replicate crossover study, meaning that all subjects that are initially randomized to one sequence (PAV-NAVA or NAVA-PAV) will afterwards be "crossed-over" to the other one. These two additional periods of measurements will allow us to account for potential carry over effects of the different interventions.
- Conditions
- Respiratory Failure
- Being tested
- PAV Ventilation, NAVA Ventilation
- Keywords
- respiration, artificial
- Medical subject headings
- Respiratory Insufficiency, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PAV VentilationProcedure or surgery
PAV is a mode of ventilation in which the only set parameter is the proportion of work/effort that is provided regardless of the ventilatory pattern the patient chooses- the patient has full control over pressure, volume, flow and time of inspiration as well as respiratory rate. In this mode, the ventilator measures patient respiratory mechanics every 10-15 breaths and delivers a level of pressure proportional to patient effort, thereby maintaining a set proportion of patient effort regardless of the patient's ventilatory pattern. The patients will be on this mode of ventilation for 60 minutes.
NAVA VentilationProcedure or surgery
With NAVA, delivery from the ventilator is triggered, controlled and cycled by the diaphragmatic EMG signal (Edi), which is measured by a specially designed nasogastric or orogastric catheter (NGT or OGT) containing EMG electrodes that cross the diaphragm. In this mode, the ventilator measures the Edi with each breath and instantaneously delivers a level of pressure proportional to Edi magnitude, thereby providing a set proportion of effort on a breath-to-breath basis. The patients will be on this mode of ventilation for 60 minutes.
| Study group | Role | What they receive |
|---|---|---|
| PAV Ventilation | Experimental | PAV is a mode of ventilation in which the only set parameter is the proportion of work/effort that is provided regardless of the ventilatory pattern the patient chooses- the patient has full control over pressure, volume, flow and time of inspiration as well as respiratory rate. In this mode, the ventilator measures patient respiratory mechanics every 10-15 breaths and delivers a level of pressure proportional to patient effort, thereby maintaining a set proportion of patient effort regardless of the patient's ventilatory pattern. The patients will be on this mode of ventilation for 60 minutes. Receives: Procedure: PAV Ventilation |
| NAVA Ventilation | Experimental | With NAVA, delivery from the ventilator is triggered, controlled and cycled by the diaphragmatic EMG signal (Edi), which is measured by a specially designed nasogastric or orogastric catheter (NGT or OGT) containing EMG electrodes that cross the diaphragm. In this mode, the ventilator measures the Edi with each breath and instantaneously delivers a level of pressure proportional to Edi magnitude, thereby providing a set proportion of effort on a breath-to-breath basis. The patients will be on this mode of ventilation for 60 minutes. Receives: Procedure: NAVA Ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-Ventilator Synchrony
Patient-ventilator synchrony will be assessed during both modes of ventilation. Data collected will include (but is not limited to) vital signs, sedation score, respiratory rate, tidal volume (Vt), peak airway pressure (Ppeak), inspiratory time and neural inspiratory time (Ti and Tni), total physiological and neural respiratory cycle time (Ttot and Tntot), waveforms of all ventilatory patterns, end-tidal CO2, esophageal pressure waveforms, Edi waveforms, and peak Edi.
Measured: 2.5 hours
Secondary outcomes (2)
Dyspnea Index
Patients who are able to interact (i.e. who are sufficiently awake and attentive) will undergo a dyspnea assessment, including a visual analogue scale for dyspnea.
Measured: 2.5 hours
Respiratory Muscle Unloading
Respiratory muscle unloading, i.e. reduction of work of breathing by the patient, will be assessed during both modes of ventilation. Data collected will include (but is not limited to) vital signs, sedation score, respiratory rate, tidal volume (Vt), peak airway pressure (Ppeak), inspiratory time and neural inspiratory time (Ti and Tni), total physiological and neural respiratory cycle time (Ttot and Tntot), waveforms of all ventilatory patterns, end-tidal CO2, esophageal pressure waveforms, Edi waveforms, and peak Edi.
Measured: 2.5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2013 (estimated)
- Study startApr 2010
- Primary completionSep 2016
- Study completionSep 2016
Why it stopped: Not subjects enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory FailureStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Scott Harris, M.D., Massachusetts General Hospital
- Investigators
- Robert S Harris, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01810510
- Sponsor's protocol ID
- 2013P000028
- Status last verified
- Nov 2016
- First submitted
- 11 Mar 2013
- Last updated
- 7 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of PAV Versus NAVA on Patient-Ventilator Synchrony and Respiratory Muscle Unloading
- ClinicalTrials.gov ID
- NCT01810510
- Acronym / sponsor ID
- 2013P000028
- Conditions
- Respiratory Failure
- Keywords
- respiration, artificial
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Not subjects enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 13 Mar 2013 (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 purpose of this study is to determine whether two modes of artificial (i.e. mechanical) ventilation have an impact on patient synchrony with the ventilator (breathing machine) and on the patient's work of breathing.
Detailed description
New, "intelligent" ventilator modes with more complex closed loops have been developed, some with a demonstrated clinical benefit. The modes of proportional assist ventilation (PAV) and neurally-adjusted ventilatory assist (NAVA) are capable of delivering ventilation proportional to patient effort and may be associated with improved patient-ventilator synchrony when compared to pressure support ventilation (PSV), a classic simple closed-loop assisted ventilation mode.
This study will study both modes of ventilation (PAV and NAVA) in each patient who is recruited, and measures of patient-ventilator synchrony and work of breathing will be taken during each mode.
Baseline data will be collected on a standardized volume-cycled control mode ventilator setting for 5 minutes and on a standardized pressure support ventilator mode for 25 minutes. Subjects will then be randomized to either PAV or NAVA ventilation and will be ventilated on that mode for 30 minutes. Equivalence of support levels between PAV and NAVA trials will be ensured by targeting the same peak (Ppeak) airway pressures. Data collected will include (but are not limited to) vital signs, sedation score, dyspnea assessment using visual analog scale, respiratory rate, tidal volume (Vt), peak airway pressure (Ppeak), inspiratory time and neural inspiratory time (Ti and Tni), total physiologic and neural respiratory cycle time (Ttot and Tntot), end-tidal CO2, esophageal pressure waveforms, waveforms of all ventilatory patterns, Edi waveforms, and peak Edi. Subjects will then be switched to the other mode of ventilation and undergo an identical 30-minute evaluation period with identical data collection. Arterial blood gas measurements will be done after any changes in ventilator settings only in subjects who have had arterial lines inserted for clinically-indicated reasons. This will be a replicate crossover study, meaning that all subjects that are initially randomized to one sequence (PAV-NAVA or NAVA-PAV) will afterwards be "crossed-over" to the other one. These two additional periods of measurements will allow us to account for potential carry over effects of the different interventions.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PAV Ventilation | Experimental | Procedure: PAV VentilationPAV is a mode of ventilation in which the only set parameter is the proportion of work/effort that is provided regardless of the ventilatory pattern the patient chooses- the patient has full control over pressure, volume, flow and time of inspiration as well as respiratory rate. In this mode, the ventilator measures patient respiratory mechanics every 10-15 breaths and delivers a level of pressure proportional to patient effort, thereby maintaining a set proportion of patient effort regardless of the patient's ventilatory pattern. The patients will be on this mode of ventilation for 60 minutes. |
| NAVA Ventilation | Experimental | Procedure: NAVA VentilationWith NAVA, delivery from the ventilator is triggered, controlled and cycled by the diaphragmatic EMG signal (Edi), which is measured by a specially designed nasogastric or orogastric catheter (NGT or OGT) containing EMG electrodes that cross the diaphragm. In this mode, the ventilator measures the Edi with each breath and instantaneously delivers a level of pressure proportional to Edi magnitude, thereby providing a set proportion of effort on a breath-to-breath basis. The patients will be on this mode of ventilation for 60 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 years or older
- Respiratory failure requiring mechanical ventilation
- Spontaneously breathing (able to generate flow/ pressure/ volume triggers on control modes of ventilation or on a mode of mechanically assisted spontaneous breathing)
- Requiring FiO2< 60% and PEEP< 10cm H2O to maintain oxygen saturations >90%
Key exclusion criteria (8 listed)
- Pregnancy
- Inability to tolerate spontaneous breathing
- Gastro-esophageal pathology (including but not limited to recent gastric or esophageal surgery, history of varices, known anatomical gastric or esophageal defects such as strictures, hernias or fistulas)
- Agitation necessitating major sedative infusions
- Hemodynamic instability necessitating active adjustments in vasopressor therapy
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 |
|---|---|---|
| PAV VentilationPAV is a mode of ventilation in which the only set parameter is the proportion of work/effort that is provided regardless of the ventilatory pattern the patient chooses- the patient has full control over pressure, volume, flow and time of inspiration as well as respiratory rate. In this mode, the ventilator measures patient respiratory mechanics every 10-15 breaths and delivers a level of pressure proportional to patient effort, thereby maintaining a set proportion of patient effort regardless of the patient's ventilatory pattern. The patients will be on this mode of ventilation for 60 minutes. | Procedure or surgery | PAV Ventilation |
| NAVA VentilationWith NAVA, delivery from the ventilator is triggered, controlled and cycled by the diaphragmatic EMG signal (Edi), which is measured by a specially designed nasogastric or orogastric catheter (NGT or OGT) containing EMG electrodes that cross the diaphragm. In this mode, the ventilator measures the Edi with each breath and instantaneously delivers a level of pressure proportional to Edi magnitude, thereby providing a set proportion of effort on a breath-to-breath basis. The patients will be on this mode of ventilation for 60 minutes. | Procedure or surgery | NAVA Ventilation |
Primary outcome
Patient-Ventilator Synchrony
Time frame: 2.5 hours
Patient-ventilator synchrony will be assessed during both modes of ventilation. Data collected will include (but is not limited to) vital signs, sedation score, respiratory rate, tidal volume (Vt), peak airway pressure (Ppeak), inspiratory time and neural inspiratory time (Ti and Tni), total physiological and neural respiratory cycle time (Ttot and Tntot), waveforms of all ventilatory patterns, end-tidal CO2, esophageal pressure waveforms, Edi waveforms, and peak Edi.
2 secondary outcomes
Dyspnea Index
Time frame: 2.5 hours
Respiratory Muscle Unloading
Time frame: 2.5 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2016.
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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.
Robert S Harris, MD 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 PAV Ventilation and NAVA Ventilation in people with Respiratory Failure, 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 4 inclusion and 8 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: withdrawn, as of the sponsor's last update on 7 Nov 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 was withdrawn before enrolling participants, so there are no results.
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?
Patient-Ventilator Synchrony (time frame: 2.5 hours). 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 Nov 2016.