NCT04699513

The Effect of Preemptive APRV on Patients With High Risk for ARDS

Completed NA Last updated 7 January 2021

What this trial tests

NA trial testing Mechanical Ventilation Mode (airway pressure release ventilation ) in Acute Respiratory Distress Syndrome in 65 participants. Completed in 30 December 2018.

Timeline

1 May 2016

Primary endpoint
30 October 2018

30 December 2018

Quick facts

Lead sponsor	Karadeniz Technical University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	65
Start date	1 May 2016
Primary completion	30 October 2018
Estimated completion	30 December 2018

Drugs / interventions tested

• Mechanical Ventilation Mode (airway pressure release ventilation )

Conditions studied

• Acute Respiratory Distress Syndrome — all drugs for Acute Respiratory Distress Syndrome →
• Intensive Care Unit — all drugs for Intensive Care Unit →

Sponsor

Karadeniz Technical University

Who can join

Adults 18 to 85, any sex, with Acute Respiratory Distress Syndrome or Intensive Care Unit. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Airway pressure release ventilation (APRV) is a mode of mechanical ventilation that alternates between two levels of continuous positive airway pressure (CPAP) support and allows spontaneous respiratory effort at either CPAP level. It is considered as an alternative, life-saving modality in patients with acute respiratory distress syndrome (ARDS) that struggle for oxygenation. Compared to the classical ventilation, APRV has been shown to provide lower peak pressure, better oxygenation, less circulatory loss, and better gas exchange without deteriorating the hemodynamic condition of the ARDS patient. This mode is believed to help to achieve the target of opening consolidated lung areas (recruitment) and to prevent repeated opening-closing of alveoli (decruitment). However, there is still insufficient and limited proof to support this hypothesis.

Recently, it has been proposed that early use of protective mechanical ventilation with APRV could be used preemptively to prevent development of ARDS in high risk patients. In that study, APRV prevented clinical and histological lung injury by protecting alveolar epithelial integrity, preserving surfactant and alveolar stability, and reducing pulmonary edema.

The primary purpose of the present study was to investigate whether early use of APRV as a lung-protecting strategy was superior to the conventional methods in a patient population with high risk of acute respiratory distress syndrome (ARDS).

Publications & conference data

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

1. The effect of preemptive airway pressure release ventilation on patients with high risk for acute respiratory distress syndrome: a randomized controlled trial.
   Küçük MP, Öztürk ÇE, İlkaya NK, Küçük AO, et al · · 2022 · cited 3× · PMID 33905798 · DOI 10.1016/j.bjane.2021.03.022