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

NCT01810510 | Withdrawn DMC

• 1 other identifier: 2013P000028
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Failure

Keywords

respiration, artificial

Outcome Measures

Primary Outcomes (1)

• 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.

  2.5 hours

Secondary Outcomes (2)

• Dyspnea Index

  2.5 hours

• Respiratory Muscle Unloading

  2.5 hours

Study Arms (2)

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.

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.

Procedure: NAVA Ventilation

Interventions

PAV Ventilation PROCEDURE

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.

PAV Ventilation

NAVA Ventilation PROCEDURE

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.

NAVA Ventilation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Respiratory Insufficiency; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Robert S Harris, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate in Medicine

Study Record Dates

• First Submitted: March 11, 2013
• First Posted: March 13, 2013
• Study Start: April 1, 2010
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: November 7, 2016

Record last verified: 2016-11

Locations

US (1)