Service de Réanimation Adultes et Soins Continus
Clermont-Ferrand, 63000, France
NCT Number: NCT04041817
Pressure support ventilation allows intubated ICU patients to breathe spontaneously. Among specific settings, the adjustment of the trigger value (or threshold for triggering the ventilator) has not been explored to date. The trigger threshold corresponds to the sensitivity of the ventilator to detect patient's inspiratory effort and then deliver the predefined pressure support to inflate the lungs and deliver a tidal volume. The purpose of this study is to explore the influence of trigger level on pulmonary and ventilatory physio (-patho)logical parameters in spontaneously breathing ICU patients.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Clermont-Ferrand, 63000, France
The use of invasive mechanical ventilation is one of the most frequent therapies in intensive care units (ICUs). There are several types of indications, depending on the failure: essentially neurological, hemodynamic or respiratory.
In recent years, the notion of lung damage induced by mechanical ventilation (VILI) has led to major changes in ventilator settings in both ICUs and operative rooms (Ors). The reduction of the tidal volume (TV) to 6-8 mL/kg of ideal body weight, the use of an individualized positive end-of-expiratory pressure (PEEP) and the possible use of pulmonary aeration optimization therapies (alveolar recruitment manoeuvres, prone positioning sessions...) have become essential to increase patient's survival.
Withdrawal of invasive mechanical ventilation remains a daily issue and traditionally requires the transition from fully controlled ventilation to pressure support ventilation. Among specific settings of the latter, the adjustment of the trigger value (or threshold for triggering the ventilator) has not been explored to date. The trigger threshold corresponds to the sensitivity of the ventilator to detect patient's inspiratory effort and then deliver the predefined pressure support to inflate the lungs and deliver a tidal volume. The lower (or more sensitive) the trigger threshold, the smallest patient's effort will be rewarded. On the other hand, the higher the threshold, the greater the inspiratory effort required from the patient. Usually, this value is set by default to the minimum level to avoid self-triggering of the ventilator. With the objective to optimize pulmonary aeration, the use of higher trigger levels could increase diaphragmatic work (with a potential re-training and reinforcement effect) and contribute to better alveolar recruitment in the postero-inferior territories that are traditionally the most impacted, following a higher diaphragmatic motion. The authors propose to explore the impact of different trigger levels on pulmonary aeration (evaluated by electrical impedance tomography) and ventilatory parameters, in order to validate our hypotheses and before considering a trial with the objective of defining individualized trigger levels, according to patient's respiratory mechanics and pulmonary parenchyma morphology, with potential benefits on ventilator weaning.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Trigger variations will be performed following increasing steps of 3 L/min every 15 minutes, from 0.2 to 15 L/min (0.2 - 3 - 6 - 9 - 12 - 15).
Time frame: T0 (before the first trigger step)
The main endpoint is the difference between the lung volume (EELV) measured by electroimpedancemetry by tomography (EIT) at the end of each trigger level (15th minute) and the basal value measured at the beginning of the protocol
Time frame: T15 minutes (last minute of the trigger step n°1)
The main endpoint is the difference between the lung volume (EELV) measured by electroimpedancemetry by tomography (EIT) at the end of each trigger level (15th minute) and the basal value measured at the beginning of the protocol
Time frame: T30 minutes (last minute of the trigger step n°2)
The main endpoint is the difference between the lung volume (EELV) measured by electroimpedancemetry by tomography (EIT) at the end of each trigger level (15th minute) and the basal value measured at the beginning of the protocol
Time frame: T45 minutes (last minute of the trigger step n°3)
The main endpoint is the difference between the lung volume (EELV) measured by electroimpedancemetry by tomography (EIT) at the end of each trigger level (15th minute) and the basal value measured at the beginning of the protocol
Time frame: T60 minutes (last minute of the trigger step n°4)
The main endpoint is the difference between the lung volume (EELV) measured by electroimpedancemetry by tomography (EIT) at the end of each trigger level (15th minute) and the basal value measured at the beginning of the protocol
Time frame: T75 minutes (last minute of the trigger step n°5)
The main endpoint is the difference between the lung volume (EELV) measured by electroimpedancemetry by tomography (EIT) at the end of each trigger level (15th minute) and the basal value measured at the beginning of the protocol
Time frame: T90 minutes (last minute of the trigger step n°6)
The main endpoint is the difference between the lung volume (EELV) measured by electroimpedancemetry by tomography (EIT) at the end of each trigger level (15th minute) and the basal value measured at the beginning of the protocol
Time frame: T105 minutes (last minute of the trigger step n°7)
The main endpoint is the difference between the lung volume (EELV) measured by electroimpedancemetry by tomography (EIT) at the end of each trigger level (15th minute) and the basal value measured at the beginning of the protocol
Time frame: T120 minutes (last minute of the trigger step n°8)
The main endpoint is the difference between the lung volume (EELV) measured by electroimpedancemetry by tomography (EIT) at the end of each trigger level (15th minute) and the basal value measured at the beginning of the protocol
Time frame: T135 minutes (last minute of the trigger step n°9)
The main endpoint is the difference between the lung volume (EELV) measured by electroimpedancemetry by tomography (EIT) at the end of each trigger level (15th minute) and the basal value measured at the beginning of the protocol
Time frame: T150 minutes (last minute of the trigger step n°10)
The main endpoint is the difference between the lung volume (EELV) measured by electroimpedancemetry by tomography (EIT) at the end of each trigger level (15th minute) and the basal value measured at the beginning of the protocol
Time frame: Through study completion, 150 minutes
Evaluation of homogeneity of pulmonary aeration with Center Of Ventilation by EIT
Time frame: Through study completion, 150 minutes
Evaluation of homogeneity of pulmonary aeration with Global Inhomogeneity index by EIT
Time frame: Through study completion, 150 minutes
Evaluation of regional impedance variation (TIV: Tidal Impedance Variation) by EIT
Time frame: Through study completion, 150 minutes
Assessement of atelectrauma (RVD: Regional Ventilation Delay) by EIT
Time frame: Through study completion, 150 minutes
Evaluation of lung volume variations by EIT (EELI : End Expiratory Lung Impedance)
Time frame: Through study completion, 150 minutes
Evaluation of maximum transpulmonary pressure (alveolar stress)
Time frame: Through study completion, 150 minutes
Alveolar strain defined as the ratio between tidal volume and Functional Residual Capacity
Time frame: Through study completion, 150 minutes
Evaluation of transpulmonary driving pressure
Time frame: Through study completion, 150 minutes
Evaluation of work of breathing (WOB) value (P01)
Time frame: Through study completion, 150 minutes
Evaluation of inspiratory occlusion pressure values (P01)
Time frame: Measurement during the last minute of each trigger step
Evaluation of energy delivered to lungs patient
Time frame: Through study completion, 150 minutes
Evaluation of the diaphragmatic thickening by ultrasound
Time frame: Through study completion, 150 minutes
Evaluation of the diaphragmatic motion by ultrasound
Time frame: Through study completion, 150 minutes
Study of the impact of patient's weight
University Hospital, Clermont-Ferrand
Other
Pulmonary and Ventilatory Effects of Trigger Modulation in Intubated ICU Patients Spontaneously Breathing With Pressure Support Ventilation. A Physiopathology Exploratory Study.
Acronym: Trigger
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