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OpenTrials
Completed

NCT Number: NCT02838524

Acceptable Range of Inspiratory Effort During Mechanical Ventilation

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Maximal inspiratory effort generated by a patient

    Time frame: During 10-15 minutes of the spontaneous breathing trial

Secondary outcomes

  1. Diaphragmatic thickening fraction

    Time frame: 15 minutes

  2. Diaphragmatic excursion

    Time frame: 15 minutes

  3. Success or failure of the spontaneous breathing trial

    Time frame: 15 minutes

  4. Muscular load-capacity balance measured by the tension-time index of the respiratory muscles

    Time frame: 15 minutes

  5. Airway occlusion pressure (P0.1) performed manually and as measured by the ventilator

    Time frame: 15 minutes

Sponsors and collaborators

Lead sponsor

Unity Health Toronto

Other

Registry information

Acronym: EFFORT

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jul 20, 2016
Registry last updated
Apr 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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