Specific Mechanical Power Assessment in Patients With Acute Respiratory Distress Syndrome

Ventilation, Mechanical Clinical Trial

Official title:

Specific Mechanical Power Assessment in Patients With Acute Respiratory Distress Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05410262
• Other study ID #: El Cruce
• Status: Completed
• Start date: July 1, 2022
• Est. completion date: December 30, 2022

Study information

• Verified date: March 2023
• Source: Hospital El Cruce
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 30, 2022
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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 ?/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.

-

Related Conditions & MeSH terms

• Acute Lung Injury
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• Ventilation, Mechanical

Intervention

Other:
• Evaluation of CT images
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).

Locations

Country	Name	City	State
Argentina	Hospital de Alta Complejidad en Red El Cruce Nestor C. Kirchner	Florencio Varela	Buenos Aires

Sponsors (1)

Lead Sponsor	Collaborator
Hospital El Cruce

Country where clinical trial is conducted

Argentina, 

References & Publications (5)

Coppola 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. — View Citation

Costa 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. — View Citation

Cressoni 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. — View Citation

Gattinoni 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	specific mechanical power	Specific mechanical power was calculated as the ratio of mechanical power to ventilable lung volume.	"immediately after the intervention/procedure/surgery"
Primary	relationship between lung load and severity of ARDS	relationship between specific mechanical power and severity of ARDS	"immediately after the intervention/procedure/surgery"
Primary	relationship between lung load and elastance of ARDS	relationship between specific mechanical power and elastance of ARDS	"immediately after the intervention/procedure/surgery"
Primary	relationship between lung load and strain	relationship between specific mechanical power and strain	"immediately after the intervention/procedure/surgery"
Primary	relationship between lung load and atelectrauma	relationship between specific mechanical power and atelectrauma	"immediately after the intervention/procedure/surgery"