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

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ClinicalTrials.gov Identifier: NCT04221737
Recruitment Status : Recruiting
First Posted : January 9, 2020
Last Update Posted : April 13, 2021
Sponsor:
Information provided by (Responsible Party):
Miguel Á Ibarra-Estrada, Hospital Civil de Guadalajara

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).

Condition or disease Intervention/treatment Phase
Acute Respiratory Distress Syndrome Device: APRV. General Electric Healthcare Engstrom ventilator system Device: Conventional. General Electric Healthcare Engstrom ventilator system Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Early Use of Airway Pressure Release Ventilation (APRV) in Patients With Acute Respiratory Distress Syndrome
Actual Study Start Date : July 15, 2017
Estimated Primary Completion Date : November 2025
Estimated Study Completion Date : January 2026


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.




Primary Outcome Measures :
  1. Mechanical ventilation free days [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. All causes mortality [ Time Frame: 28 days ]
  2. ICU length of stay [ Time Frame: 28 days ]
  3. Hospital length of stay [ Time Frame: 60 days ]
  4. Mean airway pressure, peak airway pressure, maximum P high [ Time Frame: 7 days ]
    Measured in cmH20

  5. Average expiratory time [ Time Frame: 7 days ]
    Measured in seconds

  6. Minute ventilation [ Time Frame: 7 days ]
  7. oxygen partial pressure (pO2) [ Time Frame: 7 days ]
  8. pCO2 (carbon dioxide partial pressure) [ Time Frame: 7 days ]
  9. Mean arterial pressure [ Time Frame: 7 days ]
  10. Maximum dosage of vasopressors requirement [ Time Frame: 7 days ]
  11. Richmond Sedation-Agitation Scale [ Time Frame: 7 days ]
    Range from -5 (unarousable) to +4 (combative)

  12. Average dose of propofol use [ Time Frame: 7 days ]
  13. Rate of neuromuscular blocking agents utilization [ Time Frame: 7 days ]
  14. Prone position rate [ Time Frame: 7 days ]
  15. Average of prone position sessions [ Time Frame: 7 days ]
  16. Rate of recruitment maneuvers [ Time Frame: 7 days ]
  17. Tracheostomy rate [ Time Frame: 28 days ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04221737


Contacts
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Contact: Miguel Ibarra-Estrada, Dr 3317593502 drmiguelibarra@hotmail.com
Contact: Guadalupe Aguirre-Avalos, Dr guadalupe.aavalos@academicos.udg.mx

Locations
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Mexico
Hospital Civil Fray Antonio Alcalde Recruiting
Guadalajara, Jalisco, Mexico, 44280
Contact: Miguel Ibarra, Dr    3317593502    drmiguelibarra@hotmail.com   
Contact: Guadalupe Aguirre, Dr       guadalupe.aavalos@academicos.udg.mx   
Sub-Investigator: Guadalupe Aguirre-Avalos, MD         
Sub-Investigator: Yessica García-Salas, MD         
Sub-Investigator: Quetzalcóatl Chávez-Peña, MD         
Sub-Investigator: Arnulfo López-Pulgarín, MD         
Sponsors and Collaborators
Hospital Civil de Guadalajara
Investigators
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Principal Investigator: Miguel Ibarra-Estrada, Dr Hospital Civil Fray Antonio Alcalde
Publications:

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Responsible Party: Miguel Á Ibarra-Estrada, Principal investigator, Hospital Civil de Guadalajara
ClinicalTrials.gov Identifier: NCT04221737    
Other Study ID Numbers: HCG/CEI-0632/17
First Posted: January 9, 2020    Key Record Dates
Last Update Posted: April 13, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Miguel Á Ibarra-Estrada, Hospital Civil de Guadalajara:
Acute Respiratory Distress Syndrome
Acute Lung Injury
Mechanical Ventilation
APRV
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Syndrome
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury