Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Impact of PAV Versus NAVA on Patient-Ventilator Synchrony and Respiratory Muscle Unloading

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01810510
Recruitment Status : Withdrawn (Not subjects enrolled)
First Posted : March 13, 2013
Last Update Posted : November 7, 2016
Sponsor:
Information provided by (Responsible Party):
Robert Scott Harris, M.D., Massachusetts General Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Respiratory Failure Procedure: PAV Ventilation Procedure: NAVA Ventilation Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Impact of PAV Versus NAVA on Patient-Ventilator Synchrony and Respiratory Muscle Unloading
Study Start Date : April 2010
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Arm Intervention/treatment
Experimental: PAV Ventilation
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.
Procedure: PAV Ventilation
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.

Experimental: NAVA Ventilation
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.
Procedure: NAVA Ventilation
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Dyspnea Index [ Time Frame: 2.5 hours ]
    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.

  2. Respiratory Muscle Unloading [ Time Frame: 2.5 hours ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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%

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01810510


Locations
Layout table for location information
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Layout table for investigator information
Principal Investigator: Robert S Harris, MD Massachusetts General Hospital

Layout table for additonal information
Responsible Party: Robert Scott Harris, M.D., Associate in Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01810510     History of Changes
Other Study ID Numbers: 2013P000028
First Posted: March 13, 2013    Key Record Dates
Last Update Posted: November 7, 2016
Last Verified: November 2016
Keywords provided by Robert Scott Harris, M.D., Massachusetts General Hospital:
respiration, artificial
Additional relevant MeSH terms:
Layout table for MeSH terms
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases