Effects of Large Tidal Volumes Despite Minimal Inspiratory Support in Spontaneously Ventilated Intubated Resuscitation Patients. Pathophysiological Exploratory Study.

Intensive Care Unit Clinical Trial

— InLarge  

Official title:

Effects of Large Tidal Volumes Despite Minimal Inspiratory Support in Spontaneously Ventilated Intubated Resuscitation Patients. Pathophysiological Exploratory Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05056961
• Other study ID #: InLarge (RBHP 2018 Godet 2)
• Status: Recruiting
• Phase: N/A
• Start date: June 21, 2020
• Est. completion date: June 25, 2023

Study information

• Verified date: September 2021
• Source: University Hospital, Clermont-Ferrand
• Contact: Lise Laclautre
• Phone: +33 4 73 754963
• Email: promo_interne_drci[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Some ICU ventilated patients might present with large tidal volume despite very low or inexistant presser support. Patient-Self Inflicted Lung Injury (P-SILI) might appear related with large alveolar stretch an distension. Two clinical presentations are observed: patients with or without respiratory distress signs such as supra-clavicular depression and thoracic-abdominal asynchronies. The aim of this study is to compare the pulmonary physio(-patho)logical parameters of these two types of patients (eupneic or with respiratory distress signs), and presenting important TV in spite of a minimal adjustment of the ventilatory support, except for Acute Respiratory Distress Syndrome (ARDS).

Description:

The use of invasive mechanical ventilation is one of the most frequent therapies in the intensive care unit. There are several types of indication, depending on the failure: mainly neurological, hemodynamic or respiratory. In recent years, the concept of Ventilator Induced Lung Injury (VILI) has led to changes in ventilator settings in both intensive care units and operative rooms. Thus, tidal volume (TV) reduction to 6-8 mL.kg-1 of predicted body weight, the use of an individualized positive end-expiratory pressure (PEEP) and the possible use of therapies to optimize pulmonary aeration (alveolar recruitment maneuvers, prone positioning sessions...) have become mandatory. More recently, some authors have described the existence of Patient-Self Inflicted Lung Injury (P-SILI). In certain situations (delirium, encephalopathies, pulmonary receptor stimulation, metabolic acidosis...), some patients may present, in spite of an "optimized" ventilator setting, very important VT, which may exceed 10 mL.kg-1 of theoretical ideal weight. Two circumstances of observation of these large VT needs despite low pressure supports can be observed. The first corresponds to a patient with signs of respiratory distress (signs of respiratory distress: supra-clavicular, thoraco-abdominal asynchronies...) who presents with significant inspiratory efforts. The second is a patient with no sign of respiratory distress (eupnea). In both cases, the "trigger" comes from a (hyper)-stimulation (drive) of respiratory brainstem centers. It is currently uncertain whether these two types of patients are comparable in terms of P-SILI. It is possible that in the second case, lesions are non-existent (or minimal) due to low trans-pulmonary pressure (stress) and low levels of pulmonary alveolar distension (strain). Indeed, the most likely determinant of alveolar injury is trans-pulmonary pressure, defined as the difference between upper airway pressure and pleural pressure (Ptp = Paw - Ppl). Thus, in case of a negative pathophysiological parameter, it would be preferable to sedate the patient more deeply and to temporarily consider controlled mechanical ventilation to limit the alveolar stretch and lesions. However, we know that excessive sedation of resuscitation patients increases their morbidity and mortality, by exposing them to increased duration of mechanical ventilation, and thus to the risk of pneumonia acquired under mechanical ventilation. In this context, daily sedation release tests are recommended. Physicians must therefore find the right balance between an optimal level of sedation compatible with the least deleterious ventilatory support possible. The aim of this study is to compare the pulmonary physio(-patho)logical parameters of these two types of patients (eupneic or with respiratory distress signs), and presenting important TV in spite of a minimal adjustment of the ventilatory support, except for Acute Respiratory Distress Syndrome (ARDS).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 25, 2023
• Est. primary completion date: June 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients over 18 years old
• Patients admitted to the adult intensive care unit at Estaing Hospital, Clermont-Ferrand
• Patients under invasive mechanical ventilation (intubation or tracheostomy)
• Patients with a tidal volume greater than 10 mL.kg-1 of predicted body weight despite a minimal pressure support (< 5 cmH2O)
• Patients with sedation compatible with spontaneous ventilation with inspiratory support and positive end-expiratory pressure
• Patient calm (RASS between -2 and 0)
• Consent to participate in the study from the patient or authorization to carry out the research collected from the designated trusted person (failing that, a family member or a close relative who has a close and stable relationship with the patient) in accordance with the procedures described in Title II of the First Book of the Public Health Code. If no relative is present, the patient may be included on the advice of the investigator (article L. 1111-6). A consent form for the continuation of the study and the use of the data will then be signed by the patient if and when he/she is conscious and lucid again, or if the patient is unable to express his/her consent, an authorization to continue the research will be obtained from the designated trusted person
• Patient benefiting from a Social Security system

Exclusion Criteria:

• Refusal to participate in the proposed study
• Protected adults
• Contraindication to the placement of a nasogastric tube:
• Severe uncorrected blood flow disorder
• Known naso-sinusal lesion
• Recently ligated esophageal varices (< 48h)
• Contraindication to the use of the tomographic electroimpedancemetry technique
• Thoracic lesions
• Thoracic dressings
• Pace-maker/implantable defibrillator
• Known injury to central respiratory centers, including neurocompromised patients
• Patients with Acute Respiratory Distress Syndrome (according to Berlin criteria)

Related Conditions & MeSH terms

• Brain Diseases
• Encephalopathy
• Intensive Care Unit
• Invasive Mechanical Ventilation
• Lung Injury
• Tidal Volume
• Ventilator-Induced Lung Injury
• Wounds and Injuries

Intervention

Other:
• Multiparametric mesurements
Multiparametric assessments will necessitate the use of a plastic belt to record electro-impedancemetry tomography data; and a nano-gatsric tube fitted with esophageal and gastric low pressure balloons

Locations

Country	Name	City	State
France	CHU	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	Transpulmonary driving pressure	Comparison of transpulmonary motor pressure levels during spontaneous invasive mechanical ventilation of patients with large tidal volumes (>10 mL.kg-1 theoretical ideal weight) despite minimal pressure support (inspiratory support <5 cmH20). Transpulmonary motor pressure is defined as follows: ?Ptp = (Pplateau - Inspiratory Poeso) - (PEEP - Expiratory Poeso)	During 1 hour starting from inclusion
Secondary	Transpulmonary pressure (alveolar stress)	Maximum transpulmonary pressure (alveolar stress) defined as follows: Ptp = Pplateau - Inspiratory Poeso	At inclusion and after 1 hour
Secondary	Pressure of respiratory occlusion (P0,1)	Pressure of respiratory occlusion (P01) representative of respiratory drive, automatically delivered by the ventilator	At inclusion and after 1 hour
Secondary	Driving pressure	Driving pressure	At inclusion and after 1 hour
Secondary	Work of breathing	Work of breathing as defined as follows: WOB = ?P x ?V during inspiration	At inclusion and after 1 hour
Secondary	Alveolar strain	Alveolar strain defined as follows: Strain = TV / FRC	At inclusion and after 1 hour
Secondary	Energy transmitted to the patient's lungs by the ventilator	Energy transmitted to the patient's lungs by the ventilator as defined by Gattinoni et al. (Intensive Care Medicine 2016)	At inclusion and after 1 hour