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Completed

NCT Number: NCT04041817

Pulmonary and Ventilatory Effects of Trigger Modulation in Intubated ICU

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service de Réanimation Adultes et Soins Continus

Clermont-Ferrand, 63000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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
  • Patients with Acute Respiratory Distress Syndrome (according to Berlin criteria)
  • Patients with restrictive or obstructive pulmonary pathology
  • Patients admitted post-operatively for surgery that may affect the diaphragmatic function ( thoracic or abdominal supra-mesocolic)
  • Patients with abdominal distention (ileus, intra-abdominal hyperpressure)
  • Patient whose BMI is greater than 35 kg.m-2
  • Pregnant patient
  • Patient under guardianship,

Treatment and study plan

Trigger setting of pressure support ventilation

Other

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).

Primary outcomes

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

    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

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

    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

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

    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

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

    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

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

    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

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

    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

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

    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

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

    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

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

    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

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

    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

  11. 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

  1. Homogeneity of pulmonary aeration

    Time frame: Through study completion, 150 minutes

    Evaluation of homogeneity of pulmonary aeration with Center Of Ventilation by EIT

  2. Homogeneity of pulmonary aeration

    Time frame: Through study completion, 150 minutes

    Evaluation of homogeneity of pulmonary aeration with Global Inhomogeneity index by EIT

  3. Regional impedance variation

    Time frame: Through study completion, 150 minutes

    Evaluation of regional impedance variation (TIV: Tidal Impedance Variation) by EIT

  4. Atelectrauma

    Time frame: Through study completion, 150 minutes

    Assessement of atelectrauma (RVD: Regional Ventilation Delay) by EIT

  5. Lung volume variations

    Time frame: Through study completion, 150 minutes

    Evaluation of lung volume variations by EIT (EELI : End Expiratory Lung Impedance)

  6. Transpulmonary pressure

    Time frame: Through study completion, 150 minutes

    Evaluation of maximum transpulmonary pressure (alveolar stress)

  7. Alveolar strain defined as the ratio between tidal volume and Functional Residual Capacity

    Time frame: Through study completion, 150 minutes

    Alveolar strain defined as the ratio between tidal volume and Functional Residual Capacity

  8. Transpulmonary driving pressure

    Time frame: Through study completion, 150 minutes

    Evaluation of transpulmonary driving pressure

  9. Work of breathing

    Time frame: Through study completion, 150 minutes

    Evaluation of work of breathing (WOB) value (P01)

  10. Work of breathing

    Time frame: Through study completion, 150 minutes

    Evaluation of inspiratory occlusion pressure values (P01)

  11. Energy delivered

    Time frame: Measurement during the last minute of each trigger step

    Evaluation of energy delivered to lungs patient

  12. Diaphragm thickening

    Time frame: Through study completion, 150 minutes

    Evaluation of the diaphragmatic thickening by ultrasound

  13. Diaphragm motion

    Time frame: Through study completion, 150 minutes

    Evaluation of the diaphragmatic motion by ultrasound

  14. Patient's weight

    Time frame: Through study completion, 150 minutes

    Study of the impact of patient's weight

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Official study title

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

Acronym: Trigger

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Aug 1, 2019
Registry last updated
Feb 17, 2023

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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