Acceptable Range of Inspiratory Effort During Mechanical Ventilation (EFFORT)

April 11, 2018 updated by: Unity Health Toronto
Partially assisted mechanical ventilation is ideally titrated to maintain adequate inspiratory muscle activity (i.e. preventing disuse atrophy) while avoiding excessive (i.e. fatiguing) inspiratory loads. The advent of ventilator modes enabling flow and pressure assistance in proportion to patient inspiratory effort (i.e. Proportional Assist Ventilation (PAV), Neurally-Adjusted Ventilator Assist (NAVA)) permit careful titration of ventilatory support to achieve desired levels of patient inspiratory effort. However, data on the acceptable range of values for inspiratory effort and respiratory muscle load-capacity balance during mechanical ventilation are currently very limited. Such data are critical to inform a physiologically sound evidence-based approach to titrating partially-assisted ventilatory support. This study is designed to ascertain a physiologically acceptable range of inspiratory effort in mechanically ventilated patients. The study protocol includes measurements of the respiratory system during spontaneous breathing as well as evaluating the diaphragm in real-time with the use of ultrasonography. The experimental design outlined in the present study is predicated on the assumption that the range of values for inspiratory effort and load-capacity balance observed in patients who are successfully weaned from mechanical ventilation represent the safe and appropriate range of target values.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

43

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

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5B 1W8
        • 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

Sampling Method

Non-Probability Sample

Study Population

Adult patients (age >17) receiving invasive mechanical ventilation following elective cardiac surgery who will undergo a trial of spontaneous breathing

Description

Inclusion Criteria:

- Adult patients (>17) receiving invasive mechanical ventilation following elective cardiac surgery who will undergo a trial of spontaneous breathing

Exclusion Criteria:

  • Pregnant women
  • Decompensated cardiac insufficiency or acute coronary syndrome
  • Severe COPD
  • Contraindications to esophageal catheter placement, namely known esophageal varices

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximal inspiratory effort generated by a patient
Time Frame: During 10-15 minutes of the spontaneous breathing trial
During 10-15 minutes of the spontaneous breathing trial

Secondary Outcome Measures

Outcome Measure
Time Frame
Diaphragmatic thickening fraction
Time Frame: 15 minutes
15 minutes
Diaphragmatic excursion
Time Frame: 15 minutes
15 minutes
Success or failure of the spontaneous breathing trial
Time Frame: 15 minutes
15 minutes
Muscular load-capacity balance measured by the tension-time index of the respiratory muscles
Time Frame: 15 minutes
15 minutes
Airway occlusion pressure (P0.1) performed manually and as measured by the ventilator
Time Frame: 15 minutes
15 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Unity Health Toronto

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.

General Publications

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 (ACTUAL)

September 1, 2016

Primary Completion (ACTUAL)

March 1, 2018

Study Completion (ACTUAL)

March 1, 2018

Study Registration Dates

First Submitted

July 15, 2016

First Submitted That Met QC Criteria

July 15, 2016

First Posted (ESTIMATE)

July 20, 2016

Study Record Updates

Last Update Posted (ACTUAL)

April 12, 2018

Last Update Submitted That Met QC Criteria

April 11, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • REB# 15-369

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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