NCT04221737

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).

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 15, 2017

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

January 5, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 9, 2020

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

March 19, 2025

Status Verified

March 1, 2025

Enrollment Period

8.3 years

First QC Date

January 5, 2020

Last Update Submit

March 15, 2025

Conditions

Acute Respiratory Distress Syndrome

Keywords

Acute Respiratory Distress SyndromeAcute Lung InjuryMechanical VentilationAPRV

Outcome Measures

Primary Outcomes (1)

  • Mechanical ventilation free days

    28 days

Secondary Outcomes (17)

  • 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

    7 days

  • Average expiratory time

    7 days

  • +12 more secondary outcomes

Study Arms (2)

Conventional ventilation

ACTIVE COMPARATOR

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

Time-controlled adaptive APRV

EXPERIMENTAL

Airway Pressure Release Ventilation with Time-controlled adaptive ventilation method. Allowing for spontaneous breathing.

Device: APRV. General Electric Healthcare Engstrom ventilator system

Interventions

APRV. General Electric Healthcare Engstrom ventilator systemDEVICE

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.

Time-controlled adaptive APRV
Conventional. General Electric Healthcare Engstrom ventilator systemDEVICE

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.

Conventional ventilation

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Civil Fray Antonio Alcalde

Guadalajara, Jalisco, 44280, Mexico

RECRUITING

Related Publications (6)

  • 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.

    PMID: 26746127BACKGROUND

  • 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.

    PMID: 23688302BACKGROUND

  • 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.

    PMID: 10793162BACKGROUND

  • 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.

    PMID: 21195426BACKGROUND

  • 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.

    PMID: 8004312BACKGROUND

  • 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.

    PMID: 34593706DERIVED

MeSH Terms

Conditions

Respiratory Distress SyndromeAcute Lung Injury

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration DisordersLung Injury

Study Officials

  • Miguel Ibarra-Estrada, Dr

    Hospital Civil Fray Antonio Alcalde

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Miguel Ibarra-Estrada, Dr

CONTACT

3317593502drmiguelibarra@hotmail.com

Guadalupe Aguirre-Avalos, Dr

CONTACT

guadalupe.aavalos@academicos.udg.mx

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

January 5, 2020

First Posted

January 9, 2020

Study Start

July 15, 2017

Primary Completion

November 1, 2025

Study Completion

January 1, 2026

Last Updated

March 19, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

ME(1)