Pulmonary and Ventilatory Effects of Trigger Modulation in Intubated ICU

Intubation Clinical Trial

— Trigger  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04041817
• Other study ID #: Trigger - RBHP 2018 GODET
• Secondary ID: 2018-A03307-48
• Status: Completed
• Phase: N/A
• Start date: April 3, 2019
• Est. completion date: January 31, 2023

Study information

• Verified date: February 2023
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 31, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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,

Related Conditions & MeSH terms

• ICU Patients
• Intubation
• Pulmonary Function
• Respiratory Aspiration
• Spontaneously Breathing
• Tracheotomy

Intervention

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).

Locations

Country	Name	City	State
France	Service de Réanimation Adultes et Soins Continus	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	T0 (before the first trigger step)
Primary	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	T15 minutes (last minute of the trigger step n°1)
Primary	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	T30 minutes (last minute of the trigger step n°2)
Primary	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	T45 minutes (last minute of the trigger step n°3)
Primary	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	T60 minutes (last minute of the trigger step n°4)
Primary	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	T75 minutes (last minute of the trigger step n°5)
Primary	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	T90 minutes (last minute of the trigger step n°6)
Primary	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	T105 minutes (last minute of the trigger step n°7)
Primary	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	T120 minutes (last minute of the trigger step n°8)
Primary	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	T135 minutes (last minute of the trigger step n°9)
Primary	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	T150 minutes (last minute of the trigger step n°10)
Secondary	Homogeneity of pulmonary aeration	Evaluation of homogeneity of pulmonary aeration with Center Of Ventilation by EIT	Through study completion, 150 minutes
Secondary	Homogeneity of pulmonary aeration	Evaluation of homogeneity of pulmonary aeration with Global Inhomogeneity index by EIT	Through study completion, 150 minutes
Secondary	Regional impedance variation	Evaluation of regional impedance variation (TIV: Tidal Impedance Variation) by EIT	Through study completion, 150 minutes
Secondary	Atelectrauma	Assessement of atelectrauma (RVD: Regional Ventilation Delay) by EIT	Through study completion, 150 minutes
Secondary	Lung volume variations	Evaluation of lung volume variations by EIT (EELI : End Expiratory Lung Impedance)	Through study completion, 150 minutes
Secondary	Transpulmonary pressure	Evaluation of maximum transpulmonary pressure (alveolar stress)	Through study completion, 150 minutes
Secondary	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	Through study completion, 150 minutes
Secondary	Transpulmonary driving pressure	Evaluation of transpulmonary driving pressure	Through study completion, 150 minutes
Secondary	Work of breathing	Evaluation of work of breathing (WOB) value (P01)	Through study completion, 150 minutes
Secondary	Work of breathing	Evaluation of inspiratory occlusion pressure values (P01)	Through study completion, 150 minutes
Secondary	Energy delivered	Evaluation of energy delivered to lungs patient	Measurement during the last minute of each trigger step
Secondary	Diaphragm thickening	Evaluation of the diaphragmatic thickening by ultrasound	Through study completion, 150 minutes
Secondary	Diaphragm motion	Evaluation of the diaphragmatic motion by ultrasound	Through study completion, 150 minutes
Secondary	Patient's weight	Study of the impact of patient's weight	Through study completion, 150 minutes