Early Use of Airway Pressure Release Ventilation (APRV) in ARDS

Early Use of Airway Pressure Release Ventilation (APRV) in Patients with Acute Respiratory Distress Syndrome

Airway pressure release ventilation (APRV) is a time-cycled, pressure controlled, intermittent mandatory ventilation mode with extreme inverse I:E ratios. Currently it is considered as a non-conventional ventilatory mode. The investigators aim to compare APRV with conventional mechanical ventilation (MV) in patients with acute respiratory distress syndrome (ARDS).

Study Overview

• Status: Recruiting
• Conditions: Acute Respiratory Distress Syndrome
• Intervention / Treatment: Device: Conventional. General Electric Healthcare Engstrom ventilator system; Device: APRV. General Electric Healthcare Engstrom ventilator system

Detailed Description

Despite the advances in technology and ventilatory modes, mortality of ARDS is still around 40%. Besides prone positioning, the best approach of management is low tidal volume ventilation (LTV). This 'protective ventilation' strategy is not aways effective to improve oxygenation and is associated with an increased requirement of sedation and neuromuscular blocking agents, which increase length of stay and morbidity. APRV is a ventilatory mode based on relatively high and sustained continuous positive pressure, combined with a short phase of release to allow carbon dioxide removal. It also allows unrestricted spontaneous breathing throughout respiration, independent of the ventilator cycle. Providing sustained inflation while limiting duration and frequency of release phase permits limiting volume loss, resulting in progressive and improved alveolar recruitment, an increased alveolar surface area available for gas exchange and improved ventilation-perfusion matching.

In this multi-center, prospective, randomized, controlled, open trial, the investigators aim to compare the effects and safety of the early application of time-controlled adaptive method of APRV and conventional ventilation with LTV strategy in patients with severe to moderate ARDS.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Miguel Ibarra-Estrada, Dr; Phone Number: 3317593502; Email: drmiguelibarra@hotmail.com
• Study Contact Backup: Name: Guadalupe Aguirre-Avalos, Dr; Email: guadalupe.aavalos@academicos.udg.mx

Study Locations

• Mexico
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44280
      • Recruiting
      • Hospital Civil Fray Antonio Alcalde
      • Contact: Miguel Ibarra, Dr; Phone Number: 3317593502; Email: drmiguelibarra@hotmail.com
      • Contact: Guadalupe Aguirre, Dr; Email: guadalupe.aavalos@academicos.udg.mx
      • Contact: Guadalupe Aguirre-Avalos, MD
      • Contact: Yessica García-Salas, MD
      • Contact: Quetzalcóatl Chávez-Peña, MD
      • Contact: Arnulfo López-Pulgarín, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Acute respiratory distress syndrome, according to the Berlin definition of ARDS, with adjusted pO2/FiO2 for altitude <300, and less than 48 h of endotracheal mechanical ventilation

Exclusion Criteria:

• Pregnancy
• Less than 18 years-old
• Expected duration of mechanical ventilation less than 48 h
• Preexisting conditions with an expected 3-month mortality exceeding 50%
• Concurrent chemotherapy
• Confirmed intracranial hypertension
• Catastrophic cranial trauma or neuromuscular disorders that are known to prolong mechanical ventilation
• Pneumothorax at enrollment (resolved or not)
• Do-not-resuscitate order

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional ventilation; Protective lung conventional strategy with volume-controlled ventilation (VCV) or pressure-controlled ventilation (PCV) mode, with low tidal volume and adequate positive end expiratory pressure (PEEP) level.	Device: Conventional. General Electric Healthcare Engstrom ventilator system; Lung protective ventilation consist of delivery of low tidal volumes (4-6 ml/kg PBW), high PEEP enough to avoid de-recruitment, titrated according to ARDSNet PEEP/fraction of inspired oxygen (FiO2) table, while avoiding excessive transpulmonary pressure.
Experimental: Time-controlled adaptive APRV; Airway Pressure Release Ventilation with Time-controlled adaptive ventilation method. Allowing for spontaneous breathing.	Device: APRV. General Electric Healthcare Engstrom ventilator system; APRV consist of an extended time at plateau pressure (a continuous positive airway pressure phase) comprising about 90% of the respiratory cycle, while providing very brief releases to enhance carbon dioxide removal. Time-controlled adaptive method requires interpretation of the expiratory flow curve to assess changes in lung elastance and, therefore, set the Time low to optimize carbon dioxide removal, but not at the expense of alveolar derecruitment and instability.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mechanical ventilation free days	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All causes mortality		28 days
ICU length of stay		28 days
Hospital length of stay		60 days
Mean airway pressure, peak airway pressure, maximum P high	Measured in cmH20	7 days
Average expiratory time	Measured in seconds	7 days
Minute ventilation		7 days
oxygen partial pressure (pO2)		7 days
pCO2 (carbon dioxide partial pressure)		7 days
Mean arterial pressure		7 days
Maximum dosage of vasopressors requirement		7 days
Richmond Sedation-Agitation Scale	Range from -5 (unarousable) to +4 (combative)	7 days
Average dose of propofol use		7 days
Rate of neuromuscular blocking agents utilization		7 days
Prone position rate		7 days
Average of prone position sessions		7 days
Rate of recruitment maneuvers		7 days
Tracheostomy rate		28 days

Collaborators and Investigators

• Sponsor: Hospital Civil de Guadalajara
• Investigators: Principal Investigator: Miguel Ibarra-Estrada, Dr, Hospital Civil Fray Antonio Alcalde

Publications and helpful links

General Publications

• Guerin C, Reignier J, Richard JC, Beuret P, Gacouin A, Boulain T, Mercier E, Badet M, Mercat A, Baudin O, Clavel M, Chatellier D, Jaber S, Rosselli S, Mancebo J, Sirodot M, Hilbert G, Bengler C, Richecoeur J, Gainnier M, Bayle F, Bourdin G, Leray V, Girard R, Baboi L, Ayzac L; PROSEVA Study Group. Prone positioning in severe acute respiratory distress syndrome. N Engl J Med. 2013 Jun 6;368(23):2159-68. doi: 10.1056/NEJMoa1214103. Epub 2013 May 20.
• Lopez Saubidet I, Maskin LP, Rodriguez PO, Bonelli I, Setten M, Valentini R. Mortality in patients with respiratory distress syndrome. Med Intensiva. 2016 Aug-Sep;40(6):356-63. doi: 10.1016/j.medin.2015.10.007. Epub 2015 Dec 31. English, Spanish.
• Albert S, Kubiak BD, Vieau CJ, Roy SK, DiRocco J, Gatto LA, Young JL, Tripathi S, Trikha G, Lopez C, Nieman GF. Comparison of "open lung" modes with low tidal volumes in a porcine lung injury model. J Surg Res. 2011 Mar;166(1):e71-81. doi: 10.1016/j.jss.2010.10.022. Epub 2010 Nov 12.
• Sydow M, Burchardi H, Ephraim E, Zielmann S, Crozier TA. Long-term effects of two different ventilatory modes on oxygenation in acute lung injury. Comparison of airway pressure release ventilation and volume-controlled inverse ratio ventilation. Am J Respir Crit Care Med. 1994 Jun;149(6):1550-6. doi: 10.1164/ajrccm.149.6.8004312.
• Ibarra-Estrada MA, Garcia-Salas Y, Mireles-Cabodevila E, Lopez-Pulgarin JA, Chavez-Pena Q, Garcia-Salcido R, Mijangos-Mendez JC, Aguirre-Avalos G. Use of Airway Pressure Release Ventilation in Patients With Acute Respiratory Failure Due to COVID-19: Results of a Single-Center Randomized Controlled Trial. Crit Care Med. 2022 Apr 1;50(4):586-594. doi: 10.1097/CCM.0000000000005312.
• Acute Respiratory Distress Syndrome Network; Brower RG, Matthay MA, Morris A, Schoenfeld D, Thompson BT, Wheeler A. Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med. 2000 May 4;342(18):1301-8. doi: 10.1056/NEJM200005043421801.

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2017
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: January 5, 2020
• First Submitted That Met QC Criteria: January 6, 2020
• First Posted (Actual): January 9, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 15, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Mechanical Ventilation; Acute Respiratory Distress Syndrome; APRV; Acute Lung Injury
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease; Lung Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Lung Injury; Syndrome; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: HCG/CEI-0632/17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No