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
|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|
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 (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- Mechanical ventilation free days [ Time Frame: 28 days ]
- All causes mortality [ Time Frame: 28 days ]
- ICU length of stay [ Time Frame: 28 days ]
- Hospital length of stay [ Time Frame: 60 days ]
- Mean airway pressure, peak airway pressure, maximum P high [ Time Frame: 7 days ]Measured in cmH20
- Average expiratory time [ Time Frame: 7 days ]Measured in seconds
- Minute ventilation [ Time Frame: 7 days ]
- oxygen partial pressure (pO2) [ Time Frame: 7 days ]
- pCO2 (carbon dioxide partial pressure) [ Time Frame: 7 days ]
- Mean arterial pressure [ Time Frame: 7 days ]
- Maximum dosage of vasopressors requirement [ Time Frame: 7 days ]
- Richmond Sedation-Agitation Scale [ Time Frame: 7 days ]Range from -5 (unarousable) to +4 (combative)
- Average dose of propofol use [ Time Frame: 7 days ]
- Rate of neuromuscular blocking agents utilization [ Time Frame: 7 days ]
- Prone position rate [ Time Frame: 7 days ]
- Average of prone position sessions [ Time Frame: 7 days ]
- Rate of recruitment maneuvers [ Time Frame: 7 days ]
- Tracheostomy rate [ Time Frame: 28 days ]
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
|Contact: Miguel Ibarra-Estrada, Drfirstname.lastname@example.org|
|Contact: Guadalupe Aguirre-Avalos, Dremail@example.com|
|Hospital Civil Fray Antonio Alcalde||Recruiting|
|Guadalajara, Jalisco, Mexico, 44280|
|Contact: Miguel Ibarra, Dr 3317593502 firstname.lastname@example.org|
|Contact: Guadalupe Aguirre, Dr email@example.com|
|Sub-Investigator: Guadalupe Aguirre-Avalos, MD|
|Sub-Investigator: Yessica García-Salas, MD|
|Sub-Investigator: Quetzalcóatl Chávez-Peña, MD|
|Sub-Investigator: Arnulfo López-Pulgarín, MD|
|Principal Investigator:||Miguel Ibarra-Estrada, Dr||Hospital Civil Fray Antonio Alcalde|