Back to resultsA Diaphragmatic Electrical Activity Based Optimization Strategy During Pressure Support Ventilation
Primary Purpose
Respiratory Insufficiency
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Pressure-support Eadi optimization
Sponsored by
About this trial
This is an interventional treatment trial for Respiratory Insufficiency focused on measuring Pressure-support, Asynchrony
Eligibility Criteria
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
Sites / Locations
- St Michael's Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Eadi optimized pressure-support
Arm Description
Outcomes
Primary Outcome Measures
Synchrony and patient effort determined from pressure time product measured from the esophageal pressure
Secondary Outcome Measures
WOB determinated from esophageal pressure measurement using the Campbell diagram
Number of asynchronies
Comfort score (verbal scale)
Full Information
NCT ID
NCT02067403
First Posted
February 7, 2014
Last Updated
May 21, 2015
Sponsor
Unity Health Toronto
Collaborators
University of Toronto
1. Study Identification
Unique Protocol Identification Number
NCT02067403
Brief Title
A Diaphragmatic Electrical Activity Based Optimization Strategy During Pressure Support Ventilation
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Unity Health Toronto
Collaborators
University of Toronto
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
Pressure support will be readjusted according to Eadi recording in different steps.
The optimized pressure support will be compared to the initial pressure support.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Insufficiency
Keywords
Pressure-support, Asynchrony
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Eadi optimized pressure-support
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Pressure-support Eadi optimization
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
WOB determinated from esophageal pressure measurement using the Campbell diagram
Time Frame
For each step of the protocol (10 minutes/step)
Title
Number of asynchronies
Time Frame
For each step of the protocol (10 minutes/step)
Title
Comfort score (verbal scale)
Time Frame
For each step of the protocol (10 minutes/step)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurent Brochard, MD
Organizational Affiliation
Unity Health Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
St Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B1W8
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
28137269
Citation
Beloncle F, Piquilloud L, Rittayamai N, Sinderby C, Roze H, Brochard L. A diaphragmatic electrical activity-based optimization strategy during pressure support ventilation improves synchronization but does not impact work of breathing. Crit Care. 2017 Jan 31;21(1):21. doi: 10.1186/s13054-017-1599-z.
Results Reference
derived
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A Diaphragmatic Electrical Activity Based Optimization Strategy During Pressure Support Ventilation
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