Invasive Mechanical VentilationInLargeNCT05056961
Effects of Large Tidal Volumes Despite Minimal Inspiratory Support in Spontaneously Ventilated Intubated Resuscitation Patients. Pathophysiological Exploratory Study.
A study testing Multiparametric mesurements in people with Invasive Mechanical Ventilation and Ventilator-Induced Lung Injury, run by University Hospital, Clermont-Ferrand at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Invasive Mechanical Ventilation, Ventilator-Induced Lung Injury, Patient-Self Inflicted Lung Injury
- What is being tested?
- Multiparametric mesurements
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 21 Jun 2020to 25 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 12Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU
Clermont-Ferrand, 63000
Thomas Godet, tgodet@chu-clermontferrand.fr
About this study
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).
Read the 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).
- Conditions
- Invasive Mechanical Ventilation, Ventilator-Induced Lung Injury, Patient-Self Inflicted Lung Injury, Encephalopathy, Intensive Care Unit, Tidal Volume
- Being tested
- Multiparametric mesurements
- Keywords
- ICU, Mechanical Ventilation, Ventilator-Induced Lung Injury, Patient-Self Inflicted lung Injury, Tidal volume
- Medical subject headings
- Ventilator-Induced Lung Injury, Brain Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multiparametric mesurementsOther
Also called Oesophageal pressure, Gastric pressure, P0,1, Tomography electro-impedancemetry
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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...) Receives: Other: Multiparametric mesurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: During 1 hour starting from inclusion
Secondary outcomes (6)
Transpulmonary pressure (alveolar stress)
Maximum transpulmonary pressure (alveolar stress) defined as follows:
Ptp = Pplateau - Inspiratory Poeso
Measured: At inclusion and after 1 hour
Pressure of respiratory occlusion (P0,1)
Pressure of respiratory occlusion (P01) representative of respiratory drive, automatically delivered by the ventilator
Measured: At inclusion and after 1 hour
Driving pressure
Driving pressure
Measured: At inclusion and after 1 hour
Work of breathing
Work of breathing as defined as follows:
WOB = ΔP x ΔV during inspiration
Measured: At inclusion and after 1 hour
Alveolar strain
Alveolar strain defined as follows:
Strain = TV / FRC
Measured: At inclusion and after 1 hour
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)
Measured: At inclusion and after 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2021
- Study start21 Jun 2020
- Primary completion25 Jun 2023 (estimated)
- Study completion25 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Invasive Mechanical VentilationStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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...)
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05056961
- Sponsor's protocol ID
- InLarge (RBHP 2018 Godet 2)
- Acronym
- InLarge
- Status last verified
- Sep 2021
- First submitted
- 16 Sep 2021
- Last updated
- 28 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Large Tidal Volumes Despite Minimal Inspiratory Support in Spontaneously Ventilated Intubated Resuscitation Patients. Pathophysiological Exploratory Study.
- ClinicalTrials.gov ID
- NCT05056961
- Acronym / sponsor ID
- InLarge / InLarge (RBHP 2018 Godet 2)
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 21 Jun 2020 (actual)
- Primary completion
- 25 Jun 2023 (estimated)
- Study completion
- 25 Jun 2023 (estimated)
- First posted
- 27 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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...)
| Arm | Type | Receives |
|---|---|---|
| Large tidal volumes without respiratory distress symptoms | Other | Other: Multiparametric mesurementsLarge tidal volumes (> 10 mL.kg-1 of predicted body weight) despite low pressure support, without respiratory distress symptoms |
| Large tidal volumes with respiratory distress symptoms | Other | Other: Multiparametric mesurementsLarge 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...) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (12 listed)
- Refusal to participate in the proposed study
- Protected adults
- Contraindication to the placement of a nasogastric tube:
- Contraindication to the use of the tomographic electroimpedancemetry technique
- Known injury to central respiratory centers, including neurocompromised patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multiparametric mesurementsAlso: Oesophageal pressure, Gastric pressure, P0,1, Tomography electro-impedancemetryMultiparametric 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 | Other | Large tidal volumes with respiratory distress symptoms, Large tidal volumes without respiratory distress symptoms |
Primary outcome
Transpulmonary driving pressure
Time frame: During 1 hour starting from inclusion
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)
6 secondary outcomes
Transpulmonary pressure (alveolar stress)
Time frame: At inclusion and after 1 hour
Pressure of respiratory occlusion (P0,1)
Time frame: At inclusion and after 1 hour
Driving pressure
Time frame: At inclusion and after 1 hour
Work of breathing
Time frame: At inclusion and after 1 hour
Alveolar strain
Time frame: At inclusion and after 1 hour
Energy transmitted to the patient's lungs by the ventilator
Time frame: At inclusion and after 1 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multiparametric mesurements in people with Invasive Mechanical Ventilation and Ventilator-Induced Lung Injury, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lise Laclautre (+33 4 73 754963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transpulmonary driving pressure (time frame: During 1 hour starting from inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2021.