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Clinical Trials/NCT04041817
NCT04041817
Completed
Not Applicable

Pulmonary and Ventilatory Effects of Trigger Modulation in Intubated ICU Patients Spontaneously Breathing With Pressure Support Ventilation. A Physiopathology Exploratory Study.

University Hospital, Clermont-Ferrand1 site in 1 country30 target enrollmentApril 3, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
ICU Patients
Sponsor
University Hospital, Clermont-Ferrand
Enrollment
30
Locations
1
Primary Endpoint
Lung volume (end expiratory lung volume, EELV) at each trigger level
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
April 3, 2019
End Date
January 31, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
University Hospital, Clermont-Ferrand
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Age ≥18 years
  • Patient hospitalized in the Intensive Care Unit of Clermont-Ferrand's Hospital
  • Patients with mechanical invasive ventilation in spontaneous ventilation with inspiratory support (intubation or tracheostomy)
  • Trigger level set to minimum
  • Patient under sedation compatible with spontaneous ventilation (SV) with inspiratory support (AI) and positive end-expiratory pressure (PEP) Patient calm (RASS between -2 and 0) Consent for participation or consent from patient's next of kin or inclusion according to an emergency procedure Patient benefiting from the French social security scheme

Exclusion Criteria

  • Refusal to participate in the proposed study
  • Contraindication to the installation of a nasogastric tube:
  • Severe disorder of uncorrected blood clotting
  • Known nasosinus lesion
  • Oesophageal varices recently ligated (\<48h)
  • Contraindication to the use of the electro-impedancemetry technique by tomography
  • Thoracic lesions
  • Chest dressings
  • Pace-maker / Implantable Defibrillator
  • Known lesion of central respiratory centers, including patients with neurological injury

Outcomes

Primary Outcomes

Lung volume (end expiratory lung volume, EELV) at each trigger level

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

Secondary Outcomes

  • Homogeneity of pulmonary aeration(Through study completion, 150 minutes)
  • Regional impedance variation(Through study completion, 150 minutes)
  • Atelectrauma(Through study completion, 150 minutes)
  • Lung volume variations(Through study completion, 150 minutes)
  • Transpulmonary pressure(Through study completion, 150 minutes)
  • Alveolar strain defined as the ratio between tidal volume and Functional Residual Capacity(Through study completion, 150 minutes)
  • Transpulmonary driving pressure(Through study completion, 150 minutes)
  • Work of breathing(Through study completion, 150 minutes)
  • Energy delivered(Measurement during the last minute of each trigger step)
  • Diaphragm thickening(Through study completion, 150 minutes)
  • Diaphragm motion(Through study completion, 150 minutes)
  • Patient's weight(Through study completion, 150 minutes)

Study Sites (1)

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