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Completed

NCT Number: NCT02067403

A Diaphragmatic Electrical Activity Based Optimization Strategy During Pressure Support Ventilation

Pressure support (PS) is a commonly used mode of ventilation which is triggered based upon the patient's own inspiratory efforts. For the most part, pressure support is well tolerated by patients. However, because the trigger for pressure support is an inspiratory effort by the patient, and because the resulting support is constant, the ventilator response can be "out of sync" with the patient's needs. The problem of patient-ventilator asynchrony has been documented to be large in approximately one quarter of patients who require mechanical ventilation. Asynchrony is associated with increased or abnormal work of breathing (WOB) and prolonged duration of mechanical ventilation. Diagnosing asynchrony at the bedside can be challenging. Electrical activation of the diaphragm (Eadi) recording can provide clinicians with a more accurate picture of patient-ventilator synchrony and may thus result in decreased asynchrony and decreased or normalized work of breathing for the patient. The purpose of this physiologic study is to evaluate the role of protocolized pressure support ventilation (based upon Eadi) in comparison to standard pressure support ventilation.

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Key information

Conditions

Respiratory Insufficiency Respiration Disorders Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St Michael's Hospital

Toronto, Ontario, M5B1W8, Canada

About this study

Pressure support will be readjusted according to Eadi recording in different steps.

The optimized pressure support will be compared to the initial pressure support.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients who are ventilated using a partial ventilator support mode (i.e. pressure support) and meet one of the following criteria:

  • Known chronic pulmonary obstructive disease
  • Suspected Intrinsic PEEP on the expiratory airway pressure and flow tracings
  • Resistive pressure (i.e. eak pressure-Plateau pressure) higher than 20 centimeters of water (cmH2O) at a flow of 60 L/min or higher than 15 at a flow of 45 L/min in volume controlled ventilation (preferably after a tracheal aspiration maneuver)
  • Known chronic restrictive pulmonary disease with respiratory failure
  • Restrictive pulmonary disease characterized by a measured compliance of less than 30 ml/cmH2O
  • Obesity with BMI ≥ 30 kg/m2
  • Existence of frequent asynchronies noticed on the ventilator waveforms
  • Expected duration of ventilation of more than 24 hours

Exclusion criteria

  • Contraindication to Naso/orogastric tube (NGT/OGT) placement (known esophageal problem such as hiatal hernia or esophageal varicosities, active upper gastro-intestinal bleeding, any other contraindication to the insertion of a NGT/OGT)
  • Poor short term prognosis (defined by the clinician in charge as a high risk of death during the next 7 days) or ongoing palliative treatment.
  • Patients with "Do not resuscitate" order already established and in palliative care
  • Patients younger than 18 years old

Treatment and study plan

Pressure-support Eadi optimization

Other

Primary outcomes

  1. Synchrony and patient effort determined from pressure time product measured from the esophageal pressure

    Time frame: For each step of the protocol (10 minutes/step)

Secondary outcomes

  1. WOB determinated from esophageal pressure measurement using the Campbell diagram

    Time frame: For each step of the protocol (10 minutes/step)

  2. Number of asynchronies

    Time frame: For each step of the protocol (10 minutes/step)

  3. Comfort score (verbal scale)

    Time frame: For each step of the protocol (10 minutes/step)

Sponsors and collaborators

Lead sponsor

Unity Health Toronto

Other

Collaborators

  • University of Toronto

Registry information

Official study title

A Diaphragmatic Electrical Activity Based Optimization Strategy During Pressure Support Ventilation. Effects on Work of Breathing, Patient-ventilator Synchrony and Comparison With Neurally Adjusted Ventilatory Assist

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Feb 20, 2014
Registry last updated
May 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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