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Acceptable Range of Inspiratory Effort During Mechanical Ventilation

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02838524
Acronym
EFFORT
Enrollment
43
Registered
2016-07-20
Start date
2016-09-30
Completion date
2018-03-01
Last updated
2018-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Elective Cardiac Surgery

Keywords

Spontaneous Breathing Trial, Inspiratory Effort, Mechanical Ventilation, Respiratory muscle load-capacity balance

Brief summary

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.

Interventions

None listed

Sponsors

Unity Health Toronto
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Maximal inspiratory effort generated by a patientDuring 10-15 minutes of the spontaneous breathing trial

Secondary

MeasureTime frame
Diaphragmatic thickening fraction15 minutes
Diaphragmatic excursion15 minutes
Success or failure of the spontaneous breathing trial15 minutes
Muscular load-capacity balance measured by the tension-time index of the respiratory muscles15 minutes
Airway occlusion pressure (P0.1) performed manually and as measured by the ventilator15 minutes

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026