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

NCT05056961 | Unknown

• 1 other identifier: InLarge (RBHP 2018 Godet 2)
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Invasive Mechanical Ventilation; Ventilator-Induced Lung Injury; Patient-Self Inflicted Lung Injury; Encephalopathy; Intensive Care Unit; Tidal Volume

Keywords

ICU; Mechanical Ventilation; Ventilator-Induced Lung Injury; Patient-Self Inflicted lung Injury; Tidal volume

Outcome Measures

Primary Outcomes (1)

• 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: ΔPtp = (Pplateau - Inspiratory Poeso) - (PEEP - Expiratory Poeso)

  During 1 hour starting from inclusion

Secondary Outcomes (6)

• Transpulmonary pressure (alveolar stress)

  At inclusion and after 1 hour

• Pressure of respiratory occlusion (P0,1)

  At inclusion and after 1 hour

• Driving pressure

  At inclusion and after 1 hour

• Work of breathing

  At inclusion and after 1 hour

• Alveolar strain

  At inclusion and after 1 hour

Study Arms (2)

Large tidal volumes without respiratory distress symptoms

OTHER

Large tidal volumes (\> 10 mL.kg-1 of predicted body weight) despite low pressure support, without respiratory distress symptoms

Other: Multiparametric mesurements

Large tidal volumes with respiratory distress symptoms

OTHER

Large tidal volumes (\> 10 mL.kg-1 of predicted body weight) despite low pressure support, with respiratory distress symptoms (for example, supra-clavicular and thoracic-abdominal asynchronies...)

Other: Multiparametric mesurements

Interventions

Multiparametric mesurements OTHER

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

Also known as: Oesophageal pressure, Gastric pressure, P0,1, Tomography electro-impedancemetry

Large tidal volumes with respiratory distress symptoms; Large tidal volumes without respiratory distress symptoms

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU

Clermont-Ferrand, 63000, France

RECRUITING

MeSH Terms

Conditions

Ventilator-Induced Lung Injury; Brain Diseases

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Lise Laclautre

CONTACT

+33 4 73 754963; promo_interne_drci@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two parallel groups 1. the first without respiratory distress symptoms 2. the second with respiratory distress symptoms (for example, supra-clavicular and thoracic-abdominal asynchronies...)

Study Record Dates

• First Submitted: September 16, 2021
• First Posted: September 27, 2021
• Study Start: June 21, 2020
• Primary Completion: June 25, 2023
• Study Completion: June 25, 2023
• Last Updated: September 28, 2021

Record last verified: 2021-09

Locations

FR (1)