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Airway Pressure Release Ventilation (APRV) Protocol Early Used in Acute Respiratory Distress Syndrome

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ClinicalTrials.gov Identifier: NCT02639364
Recruitment Status : Unknown
Verified December 2015 by Zhou Yongfang, West China Hospital.
Recruitment status was:  Recruiting
First Posted : December 24, 2015
Last Update Posted : December 28, 2015
Sponsor:
Information provided by (Responsible Party):
Zhou Yongfang, West China Hospital

Study Description
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Brief Summary:
The aim of this study is to assess the effects and safety of the early application of BILEVEL-APRV protocol and conventional ventilation strategy that used low tidal volume and adequate PEEP level in ARDS patients .

Condition or disease Intervention/treatment Phase
Acute Respiratory Distress Syndrome Device: Nellcor Puritan Bennett 840 ventilator system Not Applicable

Detailed Description:

Although mechanical ventilation is life-sustaining for patients with ARDS, it can perpetuate lung injury. A number of recent advances have greatly improved in the mechanical ventilation strategies and treatment for acute respiratory distress syndrome (ARDS), however, Mortality remains high, even with the use of low tidal volume and adequate positive end expiratory pressure(PEEP). Numerous experimental showed that the BILEVEL-APRV mode used in animal ARDS model can improve gas exchanges and hemodynamic tolerance of the ventilation while reducing the dosage for sedative drugs.

The aim of this single-center, prospective, randomized, controlled, open study is to compare the effects and safety of the early application of BILEVEL-APRV protocol and conventional ventilation strategy that used low tidal volume and adequate PEEP level in ARDS patients .

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: the Effects and Safety of the Early Application of Bi-level Airway Pressure Ventilation-airway Pressure Release Ventilation(BILEVEL-APRV) Protocol and Conventional Ventilation Strategy Were Compared in ARDS Patients
Study Start Date : May 2015
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: conventional ventilation strategy
The conventional ventilation strategy use volume-controlled ventilation (VCV) or pressure-controlled ventilation (PCV) mode, combination with low tidal volume and adequate PEEP level.
 Device: Nellcor Puritan Bennett 840 ventilator system
Puritan Bennett 840 ventilator can provide the VCV,PCV,Bi-level Airway Pressure Ventilation-airway Pressure Release Ventilation(BILEVER-APRV) mode.
Experimental: BILEVEL-APRV protocol
According to our BILEVEL-APRV protocol, BILEVEL-APRV APRV mode with specific settings,combination with spontaneous breathing.
 Device: Nellcor Puritan Bennett 840 ventilator system
Puritan Bennett 840 ventilator can provide the VCV,PCV,Bi-level Airway Pressure Ventilation-airway Pressure Release Ventilation(BILEVER-APRV) mode.


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

Secondary Outcome Measures :
  1. all causes mortality [ Time Frame: day 60 ]
    Participants will be followed for the duration of ICU stay

  2. all cause hospital mortality [ Time Frame: day 60 ]
    Participants will be followed for the duration of hospital stay, until day 60 maximum.

  3. Duration of stay in ICU [ Time Frame: day 60 ]
  4. Duration of hospital stay [ Time Frame: day 60 ]
  5. peak airway pressure,mean airway pressure,positive end expiratory pressure(cmH2O) [ Time Frame: day 7 ]
  6. Average dosage of sedative infusion [ Time Frame: day 7 ]
  7. Richmond Sedation-Agitation Scale [ Time Frame: day 7 ]
  8. Average dosage of vasoactive drugs each day in use [ Time Frame: day 7 ]
  9. number of patients requiring cointerventions and Adjunctive Therapies [ Time Frame: Day 28 ]
  10. number of patients requiring the use of noninvasive ventilation [ Time Frame: Day 28 ]
  11. the tracheotomy rate [ Time Frame: Day 28 ]
  12. Number of patients with a pneumothorax [ Time Frame: Day 28 ]
  13. the number of days free from organ dysfunction [ Time Frame: Day 28 ]
  14. tidal volume(ml) [ Time Frame: Day 7 ]
  15. static lung compliance（ml/cmH2O） [ Time Frame: Day 7 ]
  16. PaO2,PaCO2(mmHg) [ Time Frame: Day 7 ]
  17. Blood pressure(mmHg) [ Time Frame: Day 7 ]
  18. blood lactic acid（mmol/l） [ Time Frame: Day 7 ]
  19. minute ventilation (L) [ Time Frame: Day 7 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 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, - The receipt of endotracheal mechanical ventilation for a period was no longer than 48 hours
  • A ratio of the partial pressure of arterial oxygen (PaO2) to the fraction of inspired oxygen(FiO2) was less than 250.

Exclusion Criteria:

  • Pregnancy
  • The expected duration of mechanical ventilation was less than 48 hours
  • Intracranial hypertension (suspected or confirmed)
  • Neuromuscular disorders that are known to prolong the need for mechanical ventilation
  • Known or suspected chronic obstructive pulmonary disease(COPD)
  • Preexisting conditions with an expected 6-month mortality exceeding 50%
  • Pneumothorax (drained or not)at enrollment
  • Treatment with extracorporeal support (ECMO) at enrollment
  • There was a lack of commitment to life support.
Contacts and Locations
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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): NCT02639364


Contacts
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Contact: Yongfang Zhou, master 8618140212276 zyfmg@163.com

Locations
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China, Sichuan
Department of Critical care medicine of West China Hospital Recruiting
Chengdu, Sichuan, China, 610041
Contact: Y F zhou, MM    8613880012276      
Principal Investigator: Y F Zhou, MM         
Sponsors and Collaborators
West China Hospital
Investigators
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Study Director: Yan Kang, doctor West China Hospital
More Information
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Responsible Party: Zhou Yongfang, Principal Investigator, West China Hospital
ClinicalTrials.gov Identifier: NCT02639364    
Other Study ID Numbers: 2015 approval (156)
First Posted: December 24, 2015    Key Record Dates
Last Update Posted: December 28, 2015
Last Verified: December 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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