Ventilation, MechanicalNCT05410262
Specific Mechanical Power Assessment in Patients With Acute Respiratory Distress Syndrome
An observational study of Ventilation, Mechanical, run by Hospital El Cruce at 1 site in Argentina.
Trial summary
In ARDS patients, mechanical ventilation should minimize ventilator-induced lung injury. The mechanical power which is the energy per unit time released to the respiratory system according to the applied tidal volume, PEEP, respiratory rate, and flow should reflect the ventilator-induced lung injury Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ventilation, Mechanical
- What is being tested?
- Evaluation of CT images
- How many people
- 18 participants
- Where
- 1 siteArgentina
- Study dates
- 1 Jul 2022to 30 Dec 2022
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients consecutively admitted with ARDS, as defined according to the Berlin expert consensus
Inclusion Criteria: patients consecutively admitted with ARDS -
Exclusion Criteria: Patients who meet any of the following criteria: history of emphysema, asthma, pneumothorax or bronchopleural fistula. Severe instability condition at the time of the study: SaO2 ≤90%, shock requiring noradrenaline ≥0,5 γ/kg/min, ventricular arrhythmia, myocardial ischemia and endocranial hypertension. Esophageal pathology that contraindicates esophageal balloon placement. Severe coagulopathy (platelet count <20000/mm3 or INR >4). Inability to undergo CT imaging: morbid obesity (≥170 kg) or abdominal girth >200 cm. Patients with do-not-resuscitate (DNR) orders, pregnant women and those who participated in other research studies within the last 30 days.
-
Trial locations and contacts
1 site in 1 country.
Argentina1 site
Hospital de Alta Complejidad en Red El Cruce Nestor C. Kirchner
San Juan Bautista, Buenos Aires, 1888
About this study
In ARDS patients, mechanical ventilation should minimize ventilator-induced lung injury. The mechanical power which is the energy per unit time released to the respiratory system according to the applied tidal volume, PEEP, respiratory rate, and flow should reflect the ventilator-induced lung injury
Read the detailed description
Mechanical ventilation is an essential tool for the treatment of patients with acute respiratory distress syndrome (ARDS); however, as other strategies, it is not free of complications. Inadequate ventilation may have a negative impact on the lung that may eventually cause the development of multiple organ failure and death. This process is known as ventilator-induced lung injury (VILI). From a clinical perspective, one of the most important objectives of ARDS treatment is to avoid or mitigate the development of VILI, not only to preserve pulmonary integrity, but also to reduce mortality.
Ventilator-induced lung injury results from the interaction between the mechanical load applied to the lung and its capacity to tolerate it. Factors such as tidal volume (Vt), plateau pressure (PPlat), lung strain or insufflation pressure (ΔP), inspiratory flow rate (VI), respiratory rate (RR), excessive inspiratory effort, high levels of FiO2 and high levels of positive end-expiratory pressure (PEEP), have been directly involved in damage mechanism. With an integrating and rheological idea, the concept of mechanical power tries to encompass the majority of these factors within a measurable unit in joules per minute, as the expression of power applied on a repetitive basis on the respiratory system in ARDS. Although the concept of MP holds promise for preventing the risk of VILI, its utility has not been proven in clinical practice until now. The main value of MP over the rest of commonly used variables for the monitoring of patients with ARDS is that it includes flow on injury mechanism (kinetic energy), accepting that an inverse relationship exists between this mechanism and the capacity of alveoli to adapt to change during the ventilation cycle (strain rate), as well as it embodies the concept of process repeatability (respiratory rate), though not of its duration. This begs the question whether we should consider its value at the moment of defining a mechanical ventilation strategy. The main disadvantage of its application is that MP conceives the respiratory system in an integrated manner and not related to or standardized with the ventilable lung portion, that is ultimately the one who has to withstand the ventilatory load; in other words, the same MP may have different consequences depending on the baby lung size or its equivalent, the severity of ARDS.
The objective of this study is to evaluate the influence of the ventilable lung size on VILI mechanisms in patients suffering from ARDS treated with protective ventilation with similar MP.
- Conditions
- Ventilation, Mechanical
- Being tested
- Evaluation of CT images
- Keywords
- ARDS, Mechanical power
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of CT imagesOther
Also called Evaluation of transpulmonary pressures
A helicoidal CT scanner will be used (Aquilion CXL, Toshiba, Japan), with AIDR 3D technique (Adaptive Iterative Dose Reduction 3D) in order to minimize exposure to X-rays. Two complete thorax CT scans will be performed, one of them in expiratory pause (PEEP) and the other in inspiratory pause (PPlat). Esophageal pressure shall be measured (FluxMed GrT, Argentina) and transpulmonary pressure will be calculated at the end of inspiration (Ppl-insp) and expiration (Ppl-exp).
| Study group | Role | What they receive |
|---|---|---|
| Mechanical power and risk of ventilator-induced lung injury in patients with ARDS | This study will prospectively evaluate patients consecutively admitted with ARDS, as defined according to the Berlin expert consensus Receives: Other: Evaluation of CT images |
What is being measured
The primary outcome is the main question the study is designed to answer.
specific mechanical power
Specific mechanical power was calculated as the ratio of mechanical power to ventilable lung volume.
Measured: "immediately after the intervention/procedure/surgery"
relationship between lung load and severity of ARDS
relationship between specific mechanical power and severity of ARDS
Measured: "immediately after the intervention/procedure/surgery"
relationship between lung load and elastance of ARDS
relationship between specific mechanical power and elastance of ARDS
Measured: "immediately after the intervention/procedure/surgery"
relationship between lung load and strain
relationship between specific mechanical power and strain
Measured: "immediately after the intervention/procedure/surgery"
relationship between lung load and atelectrauma
relationship between specific mechanical power and atelectrauma
Measured: "immediately after the intervention/procedure/surgery"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2022
- Study start1 Jul 2022
- Primary completion30 Nov 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Ventilation, MechanicalStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Hospital El Cruce
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nestor Pistillo, Hospital El Cruce
- Investigators
- Nestor Pistillo, Principal investigator, Hospital El Cruce
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05410262
- Sponsor's protocol ID
- El Cruce
- Status last verified
- Mar 2023
- First submitted
- 1 Jun 2022
- Last updated
- 7 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gattinoni L, Tonetti T, Cressoni M, Cadringher P, Herrmann P, Moerer O, Protti A, Gotti M, Chiurazzi C, Carlesso E, Chiumello D, Quintel M. Ventilator-related causes of lung injury: the mechanical power. Intensive Care Med. 2016 Oct;42(10):1567-1575. doi: 10.1007/s00134-016-4505-2. Epub 2016 Sep 12.
PubMed 27620287Cressoni M, Gotti M, Chiurazzi C, Massari D, Algieri I, Amini M, Cammaroto A, Brioni M, Montaruli C, Nikolla K, Guanziroli M, Dondossola D, Gatti S, Valerio V, Vergani GL, Pugni P, Cadringher P, Gagliano N, Gattinoni L. Mechanical Power and Development of Ventilator-induced Lung Injury. Anesthesiology. 2016 May;124(5):1100-8. doi: 10.1097/ALN.0000000000001056.
PubMed 26872367Costa ELV, Slutsky AS, Brochard LJ, Brower R, Serpa-Neto A, Cavalcanti AB, Mercat A, Meade M, Morais CCA, Goligher E, Carvalho CRR, Amato MBP. Ventilatory Variables and Mechanical Power in Patients with Acute Respiratory Distress Syndrome. Am J Respir Crit Care Med. 2021 Aug 1;204(3):303-311. doi: 10.1164/rccm.202009-3467OC.
PubMed 33784486Coppola S, Caccioppola A, Froio S, Formenti P, De Giorgis V, Galanti V, Consonni D, Chiumello D. Effect of mechanical power on intensive care mortality in ARDS patients. Crit Care. 2020 May 24;24(1):246. doi: 10.1186/s13054-020-02963-x.
PubMed 32448389Gattinoni L, Marini JJ, Collino F, Maiolo G, Rapetti F, Tonetti T, Vasques F, Quintel M. The future of mechanical ventilation: lessons from the present and the past. Crit Care. 2017 Jul 12;21(1):183. doi: 10.1186/s13054-017-1750-x.
PubMed 28701178
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Specific Mechanical Power Assessment in Patients With Acute Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT05410262
- Acronym / sponsor ID
- El Cruce
- Conditions
- Ventilation, Mechanical
- Keywords
- ARDS, Mechanical power
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Hospital El CruceUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 8 Jun 2022 (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.
In ARDS patients, mechanical ventilation should minimize ventilator-induced lung injury. The mechanical power which is the energy per unit time released to the respiratory system according to the applied tidal volume, PEEP, respiratory rate, and flow should reflect the ventilator-induced lung injury
Detailed description
Mechanical ventilation is an essential tool for the treatment of patients with acute respiratory distress syndrome (ARDS); however, as other strategies, it is not free of complications. Inadequate ventilation may have a negative impact on the lung that may eventually cause the development of multiple organ failure and death. This process is known as ventilator-induced lung injury (VILI). From a clinical perspective, one of the most important objectives of ARDS treatment is to avoid or mitigate the development of VILI, not only to preserve pulmonary integrity, but also to reduce mortality.
Ventilator-induced lung injury results from the interaction between the mechanical load applied to the lung and its capacity to tolerate it. Factors such as tidal volume (Vt), plateau pressure (PPlat), lung strain or insufflation pressure (ΔP), inspiratory flow rate (VI), respiratory rate (RR), excessive inspiratory effort, high levels of FiO2 and high levels of positive end-expiratory pressure (PEEP), have been directly involved in damage mechanism. With an integrating and rheological idea, the concept of mechanical power tries to encompass the majority of these factors within a measurable unit in joules per minute, as the expression of power applied on a repetitive basis on the respiratory system in ARDS. Although the concept of MP holds promise for preventing the risk of VILI, its utility has not been proven in clinical practice until now. The main value of MP over the rest of commonly used variables for the monitoring of patients with ARDS is that it includes flow on injury mechanism (kinetic energy), accepting that an inverse relationship exists between this mechanism and the capacity of alveoli to adapt to change during the ventilation cycle (strain rate), as well as it embodies the concept of process repeatability (respiratory rate), though not of its duration. This begs the question whether we should consider its value at the moment of defining a mechanical ventilation strategy. The main disadvantage of its application is that MP conceives the respiratory system in an integrated manner and not related to or standardized with the ventilable lung portion, that is ultimately the one who has to withstand the ventilatory load; in other words, the same MP may have different consequences depending on the baby lung size or its equivalent, the severity of ARDS.
The objective of this study is to evaluate the influence of the ventilable lung size on VILI mechanisms in patients suffering from ARDS treated with protective ventilation with similar MP.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mechanical power and risk of ventilator-induced lung injury in patients with ARDS | – | Other: Evaluation of CT imagesThis study will prospectively evaluate patients consecutively admitted with ARDS, as defined according to the Berlin expert consensus |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients consecutively admitted with ARDS, as defined according to the Berlin expert consensus
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 |
|---|---|---|
| Evaluation of CT imagesAlso: Evaluation of transpulmonary pressuresA helicoidal CT scanner will be used (Aquilion CXL, Toshiba, Japan), with AIDR 3D technique (Adaptive Iterative Dose Reduction 3D) in order to minimize exposure to X-rays. Two complete thorax CT scans will be performed, one of them in expiratory pause (PEEP) and the other in inspiratory pause (PPlat). Esophageal pressure shall be measured (FluxMed GrT, Argentina) and transpulmonary pressure will be calculated at the end of inspiration (Ppl-insp) and expiration (Ppl-exp). | Other | Mechanical power and risk of ventilator-induced lung injury in patients with ARDS |
Primary outcome
specific mechanical power
Time frame: "immediately after the intervention/procedure/surgery"
Specific mechanical power was calculated as the ratio of mechanical power to ventilable lung volume.
relationship between lung load and severity of ARDS
Time frame: "immediately after the intervention/procedure/surgery"
relationship between specific mechanical power and severity of ARDS
relationship between lung load and elastance of ARDS
Time frame: "immediately after the intervention/procedure/surgery"
relationship between specific mechanical power and elastance of ARDS
relationship between lung load and strain
Time frame: "immediately after the intervention/procedure/surgery"
relationship between specific mechanical power and strain
relationship between lung load and atelectrauma
Time frame: "immediately after the intervention/procedure/surgery"
relationship between specific mechanical power and atelectrauma
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2023.
- Background: PubMed 27620287Gattinoni L, Tonetti T, Cressoni M, Cadringher P, Herrmann P, Moerer O, Protti A, Gotti M, Chiurazzi C, Carlesso E, Chiumello D, Quintel M. Ventilator-related causes of lung injury: the mechanical power. Intensive Care Med. 2016 Oct;42(10):1567-1575. doi: 10.1007/s00134-016-4505-2. Epub 2016 Sep 12.
- Background: PubMed 26872367Cressoni M, Gotti M, Chiurazzi C, Massari D, Algieri I, Amini M, Cammaroto A, Brioni M, Montaruli C, Nikolla K, Guanziroli M, Dondossola D, Gatti S, Valerio V, Vergani GL, Pugni P, Cadringher P, Gagliano N, Gattinoni L. Mechanical Power and Development of Ventilator-induced Lung Injury. Anesthesiology. 2016 May;124(5):1100-8. doi: 10.1097/ALN.0000000000001056.
- Background: PubMed 33784486Costa ELV, Slutsky AS, Brochard LJ, Brower R, Serpa-Neto A, Cavalcanti AB, Mercat A, Meade M, Morais CCA, Goligher E, Carvalho CRR, Amato MBP. Ventilatory Variables and Mechanical Power in Patients with Acute Respiratory Distress Syndrome. Am J Respir Crit Care Med. 2021 Aug 1;204(3):303-311. doi: 10.1164/rccm.202009-3467OC.
- Background: PubMed 32448389Coppola S, Caccioppola A, Froio S, Formenti P, De Giorgis V, Galanti V, Consonni D, Chiumello D. Effect of mechanical power on intensive care mortality in ARDS patients. Crit Care. 2020 May 24;24(1):246. doi: 10.1186/s13054-020-02963-x.
- Background: PubMed 28701178Gattinoni L, Marini JJ, Collino F, Maiolo G, Rapetti F, Tonetti T, Vasques F, Quintel M. The future of mechanical ventilation: lessons from the present and the past. Crit Care. 2017 Jul 12;21(1):183. doi: 10.1186/s13054-017-1750-x.
- Individual participant dataSharing planned: No
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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.
Nestor Pistillo principal investigator
Hospital El Cruce
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventilation, Mechanical, run by Hospital El Cruce at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 7 Mar 2023. 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 Argentina. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
specific mechanical power (time frame: "immediately after the intervention/procedure/surgery"). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05410262, which also lists 5 linked publications.
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 7 Mar 2023.