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

Primary Purpose

Invasive Mechanical Ventilation, Ventilator-Induced Lung Injury, Patient-Self Inflicted Lung Injury

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Multiparametric mesurements
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Invasive Mechanical Ventilation focused on measuring ICU, Mechanical Ventilation, Ventilator-Induced Lung Injury, Patient-Self Inflicted lung Injury, Tidal volume

Eligibility Criteria

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

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)

Sites / Locations

  • CHURecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Large tidal volumes without respiratory distress symptoms

Large tidal volumes with respiratory distress symptoms

Arm Description

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

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...)

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Transpulmonary pressure (alveolar stress)
Maximum transpulmonary pressure (alveolar stress) defined as follows: Ptp = Pplateau - Inspiratory Poeso
Pressure of respiratory occlusion (P0,1)
Pressure of respiratory occlusion (P01) representative of respiratory drive, automatically delivered by the ventilator
Driving pressure
Driving pressure
Work of breathing
Work of breathing as defined as follows: WOB = ΔP x ΔV during inspiration
Alveolar strain
Alveolar strain defined as follows: Strain = TV / FRC
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)

Full Information

First Posted
September 16, 2021
Last Updated
September 27, 2021
Sponsor
University Hospital, Clermont-Ferrand
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1. Study Identification

Unique Protocol Identification Number
NCT05056961
Brief Title
Effects of Large Tidal Volumes Despite Minimal Inspiratory Support in Spontaneously Ventilated Intubated Resuscitation Patients. Pathophysiological Exploratory Study.
Acronym
InLarge
Official Title
Effects of Large Tidal Volumes Despite Minimal Inspiratory Support in Spontaneously Ventilated Intubated Resuscitation Patients. Pathophysiological Exploratory Study.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 21, 2020 (Actual)
Primary Completion Date
June 25, 2023 (Anticipated)
Study Completion Date
June 25, 2023 (Anticipated)

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
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).
Detailed 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two parallel groups the first without respiratory distress symptoms the second with respiratory distress symptoms (for example, supra-clavicular and thoracic-abdominal asynchronies...)
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Large tidal volumes without respiratory distress symptoms
Arm Type
Other
Arm Description
Large tidal volumes (> 10 mL.kg-1 of predicted body weight) despite low pressure support, without respiratory distress symptoms
Arm Title
Large tidal volumes with respiratory distress symptoms
Arm Type
Other
Arm Description
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...)
Intervention Type
Other
Intervention Name(s)
Multiparametric mesurements
Other Intervention Name(s)
Oesophageal pressure, Gastric pressure, P0,1, Tomography electro-impedancemetry
Intervention Description
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
Primary Outcome Measure Information:
Title
Transpulmonary driving pressure
Description
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)
Time Frame
During 1 hour starting from inclusion
Secondary Outcome Measure Information:
Title
Transpulmonary pressure (alveolar stress)
Description
Maximum transpulmonary pressure (alveolar stress) defined as follows: Ptp = Pplateau - Inspiratory Poeso
Time Frame
At inclusion and after 1 hour
Title
Pressure of respiratory occlusion (P0,1)
Description
Pressure of respiratory occlusion (P01) representative of respiratory drive, automatically delivered by the ventilator
Time Frame
At inclusion and after 1 hour
Title
Driving pressure
Description
Driving pressure
Time Frame
At inclusion and after 1 hour
Title
Work of breathing
Description
Work of breathing as defined as follows: WOB = ΔP x ΔV during inspiration
Time Frame
At inclusion and after 1 hour
Title
Alveolar strain
Description
Alveolar strain defined as follows: Strain = TV / FRC
Time Frame
At inclusion and after 1 hour
Title
Energy transmitted to the patient's lungs by the ventilator
Description
Energy transmitted to the patient's lungs by the ventilator as defined by Gattinoni et al. (Intensive Care Medicine 2016)
Time Frame
At inclusion and after 1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lise Laclautre
Phone
+33 4 73 754963
Email
promo_interne_drci@chu-clermontferrand.fr
Facility Information:
Facility Name
CHU
City
Clermont-Ferrand
ZIP/Postal Code
63000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Godet
Email
tgodet@chu-clermontferrand.fr

12. IPD Sharing Statement

Learn more about this trial

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

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