- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02067403
A Diaphragmatic Electrical Activity Based Optimization Strategy During Pressure Support Ventilation
May 21, 2015 updated by: Unity Health Toronto
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5B1W8
- St Michael's Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Eadi optimized pressure-support
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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)
|
For each step of the protocol (10 minutes/step)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
WOB determinated from esophageal pressure measurement using the Campbell diagram
Time Frame: For each step of the protocol (10 minutes/step)
|
For each step of the protocol (10 minutes/step)
|
Number of asynchronies
Time Frame: For each step of the protocol (10 minutes/step)
|
For each step of the protocol (10 minutes/step)
|
Comfort score (verbal scale)
Time Frame: For each step of the protocol (10 minutes/step)
|
For each step of the protocol (10 minutes/step)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2014
Primary Completion (Actual)
October 1, 2014
Study Completion (Actual)
October 1, 2014
Study Registration Dates
First Submitted
February 7, 2014
First Submitted That Met QC Criteria
February 18, 2014
First Posted (Estimate)
February 20, 2014
Study Record Updates
Last Update Posted (Estimate)
May 22, 2015
Last Update Submitted That Met QC Criteria
May 21, 2015
Last Verified
May 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REB 13-363
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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