Suspended

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

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What is being tested

PAV Ventilation

+ NAVA Ventilation

Procedure
Who is being recruted

Pathologic Processes+3

+ Respiration Disorders

+ Respiratory Tract Diseases

Over 18 Years
+12 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Supportive Care Study

Interventional
Study Start: April 2010
See protocol details

Summary

Principal SponsorMassachusetts General Hospital
Last updated: November 7, 2016
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2010

Actual date on which the first participant was enrolled.

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.

Principal SponsorMassachusetts General Hospital
Last updated: November 7, 2016
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Supportive Care Study

These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Pathologic ProcessesRespiration DisordersRespiratory Tract DiseasesPathological Conditions, Signs and SymptomsRespiratory InsufficiencyRespiratory Aspiration

Criteria

4 inclusion criteria required to participate
Age 18 years or older

Requiring FiO2 < 60% and PEEP < 10cm H2O to maintain oxygen saturations > 90%

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)

8 exclusion criteria prevent from participating
Agitation necessitating major sedative infusions

Coagulopathy

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)

Hemodynamic instability necessitating active adjustments in vasopressor therapy

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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.

Group II

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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Massachusetts General Hospital

Boston, United StatesOpen Massachusetts General Hospital in Google Maps
SuspendedOne Study Center