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

Primary Purpose

Acute Respiratory Distress Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
APRV. General Electric Healthcare Engstrom ventilator system
Conventional. General Electric Healthcare Engstrom ventilator system
Sponsored by
Hospital Civil de Guadalajara
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Respiratory Distress Syndrome focused on measuring Acute Respiratory Distress Syndrome, Acute Lung Injury, Mechanical Ventilation, APRV

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Civil Fray Antonio AlcaldeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Conventional ventilation

Time-controlled adaptive APRV

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Mechanical ventilation free days

Secondary Outcome Measures

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

Full Information

First Posted
January 5, 2020
Last Updated
October 19, 2022
Sponsor
Hospital Civil de Guadalajara
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1. Study Identification

Unique Protocol Identification Number
NCT04221737
Brief Title
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

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 15, 2017 (Actual)
Primary Completion Date
November 2025 (Anticipated)
Study Completion Date
January 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Civil de Guadalajara

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Distress Syndrome
Keywords
Acute Respiratory Distress Syndrome, Acute Lung Injury, Mechanical Ventilation, APRV

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conventional ventilation
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Time-controlled adaptive APRV
Arm Type
Experimental
Arm Description
Airway Pressure Release Ventilation with Time-controlled adaptive ventilation method. Allowing for spontaneous breathing.
Intervention Type
Device
Intervention Name(s)
APRV. General Electric Healthcare Engstrom ventilator system
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Conventional. General Electric Healthcare Engstrom ventilator system
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mechanical ventilation free days
Time Frame
28 days
Secondary Outcome Measure Information:
Title
All causes mortality
Time Frame
28 days
Title
ICU length of stay
Time Frame
28 days
Title
Hospital length of stay
Time Frame
60 days
Title
Mean airway pressure, peak airway pressure, maximum P high
Description
Measured in cmH20
Time Frame
7 days
Title
Average expiratory time
Description
Measured in seconds
Time Frame
7 days
Title
Minute ventilation
Time Frame
7 days
Title
oxygen partial pressure (pO2)
Time Frame
7 days
Title
pCO2 (carbon dioxide partial pressure)
Time Frame
7 days
Title
Mean arterial pressure
Time Frame
7 days
Title
Maximum dosage of vasopressors requirement
Time Frame
7 days
Title
Richmond Sedation-Agitation Scale
Description
Range from -5 (unarousable) to +4 (combative)
Time Frame
7 days
Title
Average dose of propofol use
Time Frame
7 days
Title
Rate of neuromuscular blocking agents utilization
Time Frame
7 days
Title
Prone position rate
Time Frame
7 days
Title
Average of prone position sessions
Time Frame
7 days
Title
Rate of recruitment maneuvers
Time Frame
7 days
Title
Tracheostomy rate
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Miguel Ibarra-Estrada, Dr
Phone
3317593502
Email
drmiguelibarra@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Guadalupe Aguirre-Avalos, Dr
Email
guadalupe.aavalos@academicos.udg.mx
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miguel Ibarra-Estrada, Dr
Organizational Affiliation
Hospital Civil Fray Antonio Alcalde
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Civil Fray Antonio Alcalde
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44280
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miguel Ibarra, Dr
Phone
3317593502
Email
drmiguelibarra@hotmail.com
First Name & Middle Initial & Last Name & Degree
Guadalupe Aguirre, Dr
Email
guadalupe.aavalos@academicos.udg.mx
First Name & Middle Initial & Last Name & Degree
Guadalupe Aguirre-Avalos, MD
First Name & Middle Initial & Last Name & Degree
Yessica García-Salas, MD
First Name & Middle Initial & Last Name & Degree
Quetzalcóatl Chávez-Peña, MD
First Name & Middle Initial & Last Name & Degree
Arnulfo López-Pulgarín, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26746127
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.
Results Reference
background
PubMed Identifier
23688302
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.
Results Reference
background
PubMed Identifier
10793162
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.
Results Reference
background
PubMed Identifier
21195426
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.
Results Reference
background
PubMed Identifier
8004312
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.
Results Reference
background
PubMed Identifier
34593706
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.
Results Reference
derived

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

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