NCT04641897

Impact of Decreasing Respiratory Rate on Lung Injury Biomarkers in ARDS Patients

Completed NA Last updated 13 January 2025

What this trial tests

NA trial testing Respiratory rate modification in Acute Respiratory Distress Syndrome in 30 participants. Completed in 1 February 2022.

Timeline

1 March 2020

Primary endpoint
1 February 2022

1 February 2022

Quick facts

Lead sponsor	Pontificia Universidad Catolica de Chile
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	prevention
Enrollment	30
Start date	1 March 2020
Primary completion	1 February 2022
Estimated completion	1 February 2022
Sites	1 location across Chile

Drugs / interventions tested

• Respiratory rate modification

Conditions studied

• Acute Respiratory Distress Syndrome — all drugs for Acute Respiratory Distress Syndrome →
• Respiration, Artificial — all drugs for Respiration, Artificial →
• Ventilator-Induced Lung Injury — all drugs for Ventilator-Induced Lung Injury →

Sponsor

Pontificia Universidad Catolica de Chile — full company profile →

Who can join

18 and older, any sex, with Acute Respiratory Distress Syndrome or Respiration, Artificial. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Acute respiratory distress syndrome (ARDS) is a form of acute lung injury of inflammatory origin, which represents a public health problem worldwide due to its prevalence, and its high mortality rate, close to 40%. Mechanical ventilation is a fundamental therapy to improve gas exchange, however, it can also induce further lung injury, a phenomenon known as ventilator induced lung injury (VILI). The limitation of tidal volume is the strategy that has shown the greatest decrease in mortality and is the cornerstone of protective ventilation. However, the respiratory rate, a fundamental parameter in the programming of the mechanical ventilator, has not been evaluated in most of the main clinical studies to date. Moreover, the natural clinical response to the use of a low tidal volume strategy is the increase in respiratory rate, which may harm the lung as it increases the energy applied to the lung parenchyma. The investigators hypothesize that the use of a lower respiratory rate, tolerating moderate hypercapnia, is associated with less VILI, measured by the release of proinflammatory mediators at the systemic level (biotrauma), compared to a conventional higher respiratory rate strategy in patients with moderate to severe ARDS. This effect is mediated by lower energy applied to the pulmonary parenchyma. To confirm this hypothesis the investigators propose a prospective cross-over clinical trial in 30 adult patients with ARDS in its acute phase, which will be randomized to two sequences of ventilation. Each period will last 12 hours, and respiratory rate (RR) will be set according to PaCO2 goal: 1) Low RR, PaCO2 60-70 mmHg; and 2) High RR, PaCO2 35-40 mmHg.

Protective ventilation will be applied according to ICU standards under continuous sedation and neuromuscular blockade. Invasive systemic arterial pressure and extravascular lung water will be monitored through an arterial catheter (PICCO® system), and airway and esophageal pressures and hemodynamics continuously measured throughout the protocol. The main outcome will be Interleukin-6 in plasma. At baseline and at the end of each period blood samples will be taken for analysis, and electrical impedance tomography (EIT) and transthoracic echocardiography will be registered. After the protocol, patients will continue their management according to ICU standards.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Effect of decreasing respiratory rate on the mechanical power of ventilation and lung injury biomarkers: a randomized cross-over clinical study in COVID-19 ARDS patients.
   Damiani LF, Basoalto R, Oviedo V, Alegria L, et al · · 2025 · PMID 40632387 · DOI 10.1186/s40635-025-00782-4