NCT02067403

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 7, 2014

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 20, 2014

Completed
9 days until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

May 22, 2015

Status Verified

May 1, 2015

Enrollment Period

7 months

First QC Date

February 7, 2014

Last Update Submit

May 21, 2015

Conditions

Respiratory Insufficiency

Keywords

Pressure-supportAsynchrony

Outcome Measures

Primary Outcomes (1)

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

    For each step of the protocol (10 minutes/step)

Secondary Outcomes (3)

  • WOB determinated from esophageal pressure measurement using the Campbell diagram

    For each step of the protocol (10 minutes/step)

  • Number of asynchronies

    For each step of the protocol (10 minutes/step)

  • Comfort score (verbal scale)

    For each step of the protocol (10 minutes/step)

Study Arms (1)

Eadi optimized pressure-support

EXPERIMENTAL
Other: Pressure-support Eadi optimization

Interventions

Pressure-support Eadi optimizationOTHER
Eadi optimized pressure-support

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Michael's Hospital

Toronto, Ontario, M5B1W8, Canada

Location

Related Publications (1)

  • 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.

    PMID: 28137269DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Study Officials

  • Laurent Brochard, MD

    Unity Health Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2014

First Posted

February 20, 2014

Study Start

March 1, 2014

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

May 22, 2015

Record last verified: 2015-05

Locations

CA(1)