Mechanical Power and Ventilatory Ratio in ARDS

Acute Respiratory Distress Syndrome Clinical Trial

Official title:

Relation Between Mechanical Power and Ventilatory Ratio in Patients With Acute Respiratory Distress Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05761626
• Other study ID #: Universidad de Magallanes
• Status: Completed
• Start date: March 1, 2016
• Est. completion date: February 10, 2023

Study information

• Verified date: March 2023
• Source: Ramos Mejía Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Mechanical power (MP) and ventilatory ratio (VR) are variables associated with outcomes in patients with acute respiratory distress syndrome (ARDS). In respiratory setting, the optimization of MP should lead to an increase in VR. Therefore, the objectives of this study are: to assess the relationship between MP and VR and to compare the components of MP (ventilatory variables) according to a level of MP (17 J/minute) considered harmful.

Description:

In patients with acute respiratory distress syndrome (ARDS), mechanical ventilation is a life support therapy; however, its use is associated with ventilator-induced lung injury (VILI). VILI is the final manifestation of changes in lung mechanics that occurs in each ventilatory cycle in a damaged lung parenchyma. In each respiratory cycle, a certain amount of mechanical energy is transferred to the lung, which is used primarily to overcome airway resistance and expand the chest wall.This mechanical energy multiplied by the respiratory rate (RR) is what is known as mechanical power (MP), which reflects the amount of energy applied to the respiratory system per minute during mechanical ventilation (MV). The amount of energy transferred from the ventilator to the patient is measured in joules (J), while MP is defined as the amount of energy transferred per unit of time (J/minute). MP is a summary variable that includes: tidal volume (TV), RR, flow, positive end-expiratory pressure (PEEP) and driving pressure (difference between plateau pressure and PEEP). An experimental study showed that the increase in MP, through the increase in RR, was associated with VILI. There is also evidence that MP can predict the risk of mortality in mechanically ventilated patients with and without ARDS. In addition, a constant increase in the risk of death has been found with MP greater than 17.0 J/min. In turn, since this value could vary according to lung size, it has been proposed that MP normalized to lung size (assessed through lung compliance) may have better performance. One way to optimize the MP would be to limit the RR and TV. However, the decrease in any of these ventilatory variables can lead to inefficient ventilation and an increase in the arterial pressure of carbon dioxide (PaCO2). In recent years, the ventilatory ratio (VR) has been assessed. VR is a unitless ratio that it can be easily calculated using routine bedside variables. Its value reflects the ability of the lungs to excrete CO2 adequately. Higher values of VR were associated with higher pulmonary dead space and with mortality. In the ventilatory setting, the optimization of MP would lead to an increase in VR.In addition, and since the components of MP contribute unequally to its value, it would be important to be able to establish the variables that could be decisive in the ventilatory setting. For this reason, the primary outcome is to assess the relationship between PM and VR. The secondary outcomes are: to estimate the relationship between PM in relation to static compliance (PM/C) and VR, and to assess the differences in respiratory variables considering a MP of 17 J/min as cut-off point.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: February 10, 2023
• Est. primary completion date: February 10, 2023
• Gender: All
• Age group: 15 Years and older

Eligibility

Inclusion Criteria:

• patients who have been receiving mechanical ventilation (MV) and have been defined as with ARDS according to the Berlin definition

Exclusion Criteria:

• patients with chronic pulmonary disease

• patients with an expected duration of MV shorter than 48 h

• patients with a high risk of death within 3 months for reasons other than ARDS

• patients having made the decision to withhold life-sustaining treatment.

Related Conditions & MeSH terms

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

Intervention

Other:
• MP < 17 J/min
assessment of the ventilatory variables according to the MP value (< or >= 17 J/min)

Locations

Country	Name	City	State
Argentina	Hospital Regional Rio Gallegos	Rio Gallegos	Santa Cruz

Sponsors (1)

Lead Sponsor	Collaborator
Ramos Mejía Hospital

Country where clinical trial is conducted

Argentina, 

References & Publications (9)

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 — View Citation

Maj R, Palermo P, Gattarello S, Brusatori S, D'Albo R, Zinnato C, Velati M, Romitti F, Busana M, Wieditz J, Herrmann P, Moerer O, Quintel M, Meissner K, Sanderson B, Chiumello D, Marini JJ, Camporota L, Gattinoni L. Ventilatory ratio, dead space, and venous admixture in patients with acute respiratory distress syndrome. Br J Anaesth. 2023 Mar;130(3):360-367. doi: 10.1016/j.bja.2022.10.035. Epub 2022 Dec 2. — View Citation

Marini JJ, Jaber S. Dynamic predictors of VILI risk: beyond the driving pressure. Intensive Care Med. 2016 Oct;42(10):1597-1600. doi: 10.1007/s00134-016-4534-x. Epub 2016 Sep 16. No abstract available. — View Citation

Marini JJ. How I optimize power to avoid VILI. Crit Care. 2019 Oct 21;23(1):326. doi: 10.1186/s13054-019-2638-8. No abstract available. — View Citation

Serpa Neto A, Deliberato RO, Johnson AEW, Bos LD, Amorim P, Pereira SM, Cazati DC, Cordioli RL, Correa TD, Pollard TJ, Schettino GPP, Timenetsky KT, Celi LA, Pelosi P, Gama de Abreu M, Schultz MJ; PROVE Network Investigators. Mechanical power of ventilation is associated with mortality in critically ill patients: an analysis of patients in two observational cohorts. Intensive Care Med. 2018 Nov;44(11):1914-1922. doi: 10.1007/s00134-018-5375-6. Epub 2018 Oct 5. — View Citation

Sinha P, Calfee CS, Beitler JR, Soni N, Ho K, Matthay MA, Kallet RH. Physiologic Analysis and Clinical Performance of the Ventilatory Ratio in Acute Respiratory Distress Syndrome. Am J Respir Crit Care Med. 2019 Feb 1;199(3):333-341. doi: 10.1164/rccm.201804-0692OC. — View Citation

Sinha P, Fauvel NJ, Singh S, Soni N. Ventilatory ratio: a simple bedside measure of ventilation. Br J Anaesth. 2009 May;102(5):692-7. doi: 10.1093/bja/aep054. Epub 2009 Apr 3. — View Citation

Urner M, Juni P, Hansen B, Wettstein MS, Ferguson ND, Fan E. Time-varying intensity of mechanical ventilation and mortality in patients with acute respiratory failure: a registry-based, prospective cohort study. Lancet Respir Med. 2020 Sep;8(9):905-913. doi: 10.1016/S2213-2600(20)30325-8. Epub 2020 Jul 28. — View Citation

Zhang Z, Zheng B, Liu N, Ge H, Hong Y. Mechanical power normalized to predicted body weight as a predictor of mortality in patients with acute respiratory distress syndrome. Intensive Care Med. 2019 Jun;45(6):856-864. doi: 10.1007/s00134-019-05627-9. Epub 2019 May 6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the correlation between mechanical power (MP) and ventilatory rate (VR)	The relationship (correlation) between MP and VR will be assessed, according to the value of both variables on day 3 of mechanical ventilation.	First day of mechanical ventilation
Secondary	To determine the correlation between mechanical power (MP) and static compliance (SC) with ventilatory rate (VR). (MP/SC)/VR	The relationship (correlation) between mechanical power (MP) and static compliance (SC) with ventilatory rate (VR) will be assessed, according to the value of both variables on day 3 of mechanical ventilation.	First day of mechanical ventilation
Secondary	Assess the behavior of the variables according to the MP value (> or < 17 j/min)	The variables will be compared according to the MP value (< or >= 17 J/min)	3rd day of mechanical ventilation
Secondary	Assess the hydric balance according to the MP value (> or < 17 j/min)	The hydric balance will be compared according to the MP value (< or >= 17 J/min)	3rd day of mechanical ventilation
Secondary	Assess the behavior of the variables according to the MP/SC value (> or < 0.47 j/min)	The variables will be compared according to the MP/SC value (< or >= 0.47 J/min)	3rd day of mechanical ventilation