Clinical trial NCT04221737: Early Use of Airway Pressure Release Ventilation (APRV) in ARDS
Official title: Early Use of Airway Pressure Release Ventilation (APRV) in Patients With Acute Respiratory Distress Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Respiratory Distress Syndrome
Keywords: Acute Respiratory Distress Syndrome
Acute Lung Injury
Mechanical Ventilation
APRV
Lead sponsor: Hospital Civil de Guadalajara
Sponsor class: OTHER
First posted: 2020-01-09
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mechanical ventilation free days
timeFrame: 28 days
Secondary outcomes:
measure: All causes mortality
timeFrame: 28 days
measure: ICU length of stay
timeFrame: 28 days
measure: Hospital length of stay
timeFrame: 60 days
measure: Mean airway pressure, peak airway pressure, maximum P high
timeFrame: 7 days
measure: Average expiratory time
timeFrame: 7 days
measure: Minute ventilation
timeFrame: 7 days
measure: oxygen partial pressure (pO2)
timeFrame: 7 days
measure: pCO2 (carbon dioxide partial pressure)
timeFrame: 7 days
measure: Mean arterial pressure
timeFrame: 7 days
measure: Maximum dosage of vasopressors requirement
timeFrame: 7 days
measure: Richmond Sedation-Agitation Scale
timeFrame: 7 days
measure: Average dose of propofol use
timeFrame: 7 days
measure: Rate of neuromuscular blocking agents utilization
timeFrame: 7 days
measure: Prone position rate
timeFrame: 7 days
measure: Average of prone position sessions
timeFrame: 7 days
measure: Rate of recruitment maneuvers
timeFrame: 7 days
measure: Tracheostomy rate
timeFrame: 28 days
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Hospital Civil Fray Antonio Alcalde
state: Jalisco
Study officials:
affiliation: Hospital Civil Fray Antonio Alcalde
name: Miguel Ibarra-Estrada, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.