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Pulmonary and Ventilatory Effects of Trigger Modulation in Intubated ICU (Trigger)

Primary Purpose

ICU Patients, Intubation, Spontaneously Breathing

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Trigger setting of pressure support ventilation
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ICU Patients focused on measuring ICU, Pressure support ventilation, Spontaneous breathing, Trigger, Weaning of mechanical ventilation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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,

Sites / Locations

  • Service de Réanimation Adultes et Soins Continus

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Trigger increasing steps

Arm Description

Trigger variations will be performed following increasing steps of 2 L/min every 15 minutes. End expiratory lung volume and lung aeration will be conducted using elecrical impedance tomography. Diaphragmatic motion and thickening will be analyzed by ultrasonography. Work of breathing will be evaluated using gastric and oesophageal pressure measurements. Measurements will be conducted during the last minute of each step.

Outcomes

Primary Outcome Measures

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

Homogeneity of pulmonary aeration
Evaluation of homogeneity of pulmonary aeration with Center Of Ventilation by EIT
Homogeneity of pulmonary aeration
Evaluation of homogeneity of pulmonary aeration with Global Inhomogeneity index by EIT
Regional impedance variation
Evaluation of regional impedance variation (TIV: Tidal Impedance Variation) by EIT
Atelectrauma
Assessement of atelectrauma (RVD: Regional Ventilation Delay) by EIT
Lung volume variations
Evaluation of lung volume variations by EIT (EELI : End Expiratory Lung Impedance)
Transpulmonary pressure
Evaluation of maximum transpulmonary pressure (alveolar stress)
Alveolar strain defined as the ratio between tidal volume and Functional Residual Capacity
Alveolar strain defined as the ratio between tidal volume and Functional Residual Capacity
Transpulmonary driving pressure
Evaluation of transpulmonary driving pressure
Work of breathing
Evaluation of work of breathing (WOB) value (P01)
Work of breathing
Evaluation of inspiratory occlusion pressure values (P01)
Energy delivered
Evaluation of energy delivered to lungs patient
Diaphragm thickening
Evaluation of the diaphragmatic thickening by ultrasound
Diaphragm motion
Evaluation of the diaphragmatic motion by ultrasound
Patient's weight
Study of the impact of patient's weight

Full Information

First Posted
July 25, 2019
Last Updated
February 16, 2023
Sponsor
University Hospital, Clermont-Ferrand
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1. Study Identification

Unique Protocol Identification Number
NCT04041817
Brief Title
Pulmonary and Ventilatory Effects of Trigger Modulation in Intubated ICU
Acronym
Trigger
Official Title
Pulmonary and Ventilatory Effects of Trigger Modulation in Intubated ICU Patients Spontaneously Breathing With Pressure Support Ventilation. A Physiopathology Exploratory Study.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
April 3, 2019 (Actual)
Primary Completion Date
January 31, 2023 (Actual)
Study Completion Date
January 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ICU Patients, Intubation, Spontaneously Breathing, Pulmonary Function, Tracheotomy
Keywords
ICU, Pressure support ventilation, Spontaneous breathing, Trigger, Weaning of mechanical ventilation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
Statistical analysis will be conducted by an independant statistician not involved in data collection
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Trigger increasing steps
Arm Type
Experimental
Arm Description
Trigger variations will be performed following increasing steps of 2 L/min every 15 minutes. End expiratory lung volume and lung aeration will be conducted using elecrical impedance tomography. Diaphragmatic motion and thickening will be analyzed by ultrasonography. Work of breathing will be evaluated using gastric and oesophageal pressure measurements. Measurements will be conducted during the last minute of each step.
Intervention Type
Other
Intervention Name(s)
Trigger setting of pressure support ventilation
Intervention Description
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 Outcome Measure Information:
Title
Lung volume (end expiratory lung volume, EELV) at each trigger level
Description
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
T0 (before the first trigger step)
Title
Lung volume (end expiratory lung volume, EELV) at each trigger level
Description
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)
Title
Lung volume (end expiratory lung volume, EELV) at each trigger level
Description
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)
Title
Lung volume (end expiratory lung volume, EELV) at each trigger level
Description
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)
Title
Lung volume (end expiratory lung volume, EELV) at each trigger level
Description
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)
Title
Lung volume (end expiratory lung volume, EELV) at each trigger level
Description
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)
Title
Lung volume (end expiratory lung volume, EELV) at each trigger level
Description
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)
Title
Lung volume (end expiratory lung volume, EELV) at each trigger level
Description
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)
Title
Lung volume (end expiratory lung volume, EELV) at each trigger level
Description
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)
Title
Lung volume (end expiratory lung volume, EELV) at each trigger level
Description
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)
Title
Lung volume (end expiratory lung volume, EELV) at each trigger level
Description
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)
Secondary Outcome Measure Information:
Title
Homogeneity of pulmonary aeration
Description
Evaluation of homogeneity of pulmonary aeration with Center Of Ventilation by EIT
Time Frame
Through study completion, 150 minutes
Title
Homogeneity of pulmonary aeration
Description
Evaluation of homogeneity of pulmonary aeration with Global Inhomogeneity index by EIT
Time Frame
Through study completion, 150 minutes
Title
Regional impedance variation
Description
Evaluation of regional impedance variation (TIV: Tidal Impedance Variation) by EIT
Time Frame
Through study completion, 150 minutes
Title
Atelectrauma
Description
Assessement of atelectrauma (RVD: Regional Ventilation Delay) by EIT
Time Frame
Through study completion, 150 minutes
Title
Lung volume variations
Description
Evaluation of lung volume variations by EIT (EELI : End Expiratory Lung Impedance)
Time Frame
Through study completion, 150 minutes
Title
Transpulmonary pressure
Description
Evaluation of maximum transpulmonary pressure (alveolar stress)
Time Frame
Through study completion, 150 minutes
Title
Alveolar strain defined as the ratio between tidal volume and Functional Residual Capacity
Description
Alveolar strain defined as the ratio between tidal volume and Functional Residual Capacity
Time Frame
Through study completion, 150 minutes
Title
Transpulmonary driving pressure
Description
Evaluation of transpulmonary driving pressure
Time Frame
Through study completion, 150 minutes
Title
Work of breathing
Description
Evaluation of work of breathing (WOB) value (P01)
Time Frame
Through study completion, 150 minutes
Title
Work of breathing
Description
Evaluation of inspiratory occlusion pressure values (P01)
Time Frame
Through study completion, 150 minutes
Title
Energy delivered
Description
Evaluation of energy delivered to lungs patient
Time Frame
Measurement during the last minute of each trigger step
Title
Diaphragm thickening
Description
Evaluation of the diaphragmatic thickening by ultrasound
Time Frame
Through study completion, 150 minutes
Title
Diaphragm motion
Description
Evaluation of the diaphragmatic motion by ultrasound
Time Frame
Through study completion, 150 minutes
Title
Patient's weight
Description
Study of the impact of patient's weight
Time Frame
Through study completion, 150 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 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,
Facility Information:
Facility Name
Service de Réanimation Adultes et Soins Continus
City
Clermont-Ferrand
ZIP/Postal Code
63000
Country
France

12. IPD Sharing Statement

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Pulmonary and Ventilatory Effects of Trigger Modulation in Intubated ICU

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