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

February 16, 2023 updated by: University Hospital, Clermont-Ferrand

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France, 63000
        • Service de Réanimation Adultes et Soins Continus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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,

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Trigger increasing steps

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.
Other: Trigger setting of pressure support ventilation
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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
T0 (before the first trigger step)
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
T15 minutes (last minute of the trigger step n°1)
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
T30 minutes (last minute of the trigger step n°2)
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
T45 minutes (last minute of the trigger step n°3)
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
T60 minutes (last minute of the trigger step n°4)
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
T75 minutes (last minute of the trigger step n°5)
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
T90 minutes (last minute of the trigger step n°6)
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
T105 minutes (last minute of the trigger step n°7)
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
T120 minutes (last minute of the trigger step n°8)
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
T135 minutes (last minute of the trigger step n°9)
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
T150 minutes (last minute of the trigger step n°10)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Homogeneity of pulmonary aeration
Time Frame: Through study completion, 150 minutes
Evaluation of homogeneity of pulmonary aeration with Center Of Ventilation by EIT
Through study completion, 150 minutes
Homogeneity of pulmonary aeration
Time Frame: Through study completion, 150 minutes
Evaluation of homogeneity of pulmonary aeration with Global Inhomogeneity index by EIT
Through study completion, 150 minutes
Regional impedance variation
Time Frame: Through study completion, 150 minutes
Evaluation of regional impedance variation (TIV: Tidal Impedance Variation) by EIT
Through study completion, 150 minutes
Atelectrauma
Time Frame: Through study completion, 150 minutes
Assessement of atelectrauma (RVD: Regional Ventilation Delay) by EIT
Through study completion, 150 minutes
Lung volume variations
Time Frame: Through study completion, 150 minutes
Evaluation of lung volume variations by EIT (EELI : End Expiratory Lung Impedance)
Through study completion, 150 minutes
Transpulmonary pressure
Time Frame: Through study completion, 150 minutes
Evaluation of maximum transpulmonary pressure (alveolar stress)
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
Alveolar strain defined as the ratio between tidal volume and Functional Residual Capacity
Through study completion, 150 minutes
Transpulmonary driving pressure
Time Frame: Through study completion, 150 minutes
Evaluation of transpulmonary driving pressure
Through study completion, 150 minutes
Work of breathing
Time Frame: Through study completion, 150 minutes
Evaluation of work of breathing (WOB) value (P01)
Through study completion, 150 minutes
Work of breathing
Time Frame: Through study completion, 150 minutes
Evaluation of inspiratory occlusion pressure values (P01)
Through study completion, 150 minutes
Energy delivered
Time Frame: Measurement during the last minute of each trigger step
Evaluation of energy delivered to lungs patient
Measurement during the last minute of each trigger step
Diaphragm thickening
Time Frame: Through study completion, 150 minutes
Evaluation of the diaphragmatic thickening by ultrasound
Through study completion, 150 minutes
Diaphragm motion
Time Frame: Through study completion, 150 minutes
Evaluation of the diaphragmatic motion by ultrasound
Through study completion, 150 minutes
Patient's weight
Time Frame: Through study completion, 150 minutes
Study of the impact of patient's weight
Through study completion, 150 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Clermont-Ferrand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 3, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 25, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 30, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 1, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 17, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 16, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Trigger - RBHP 2018 GODET
  • 2018-A03307-48 (Other Identifier: ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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