Respiratory InsufficiencyNCT02067403
A Diaphragmatic Electrical Activity Based Optimization Strategy During Pressure Support Ventilation
A study testing Pressure-support Eadi optimization in people with Respiratory Insufficiency, run by Unity Health Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Insufficiency
- What is being tested?
- Pressure-support Eadi optimization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2014to Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- Obesity with BMI ≥ 30 kg/m2
- Existence of frequent asynchronies noticed on the ventilator waveforms
- Expected duration of ventilation of more than 24 hours
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Respiratory Insufficiency
- Being tested
- Pressure-support Eadi optimization
- Keywords
- Pressure-support, Asynchrony
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pressure-support Eadi optimizationOther
| Study group | Role | What they receive |
|---|---|---|
| Eadi optimized pressure-support | Experimental | Not described Receives: Other: Pressure-support Eadi optimization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Synchrony and patient effort determined from pressure time product measured from the esophageal pressure
Measured: For each step of the protocol (10 minutes/step)
Secondary outcomes (3)
WOB determinated from esophageal pressure measurement using the Campbell diagram
Measured: For each step of the protocol (10 minutes/step)
Number of asynchronies
Measured: For each step of the protocol (10 minutes/step)
Comfort score (verbal scale)
Measured: For each step of the protocol (10 minutes/step)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2014 (estimated)
- Study startMar 2014
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- University of Toronto
- Responsible party
- Sponsor
- Investigators
- Laurent Brochard, MD, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02067403
- Sponsor's protocol ID
- REB 13-363
- Status last verified
- May 2015
- First submitted
- 7 Feb 2014
- Last updated
- 22 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28137269
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02067403
- Acronym / sponsor ID
- REB 13-363
- Conditions
- Respiratory Insufficiency
- Keywords
- Pressure-support, Asynchrony
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Collaborators
- University of Toronto
- Study start
- Mar 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 20 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eadi optimized pressure-support | Experimental | Other: Pressure-support Eadi optimization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pressure-support Eadi optimization | Other | Eadi optimized pressure-support |
Primary outcome
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)
3 secondary outcomes
WOB determinated from esophageal pressure measurement using the Campbell diagram
Time frame: For each step of the protocol (10 minutes/step)
Number of asynchronies
Time frame: For each step of the protocol (10 minutes/step)
Comfort score (verbal scale)
Time frame: For each step of the protocol (10 minutes/step)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2015.
- Derived from this study: PubMed 28137269Beloncle 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurent Brochard, MD principal investigator
Unity Health Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pressure-support Eadi optimization in people with Respiratory Insufficiency, run by Unity Health Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02067403, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2015.