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A Multiple Centre,Random Control Study :Early Use of Airway Pressure Release Ventilation (APRV) Plus Protocol in ARDS

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ClinicalTrials.gov Identifier: NCT03549910
Recruitment Status : Not yet recruiting
First Posted : June 8, 2018
Last Update Posted : June 8, 2018
Sponsor:
Information provided by (Responsible Party):
Kang Yan, West China Hospital

Brief Summary:

Animal experimentals have shown that the more physiology-driven airway pressure release ventilation (APRV) methodologies in ARDS may significantly improve alveolar recruitment and gas exchange, increased homogeneity, and attenuate lung injury, without circulatory depression, as compared with conventional low tial volume lung protective ventilation. our previous single centre,random control study showed that clinical benefit for early use of APRV in ARDS. Nonetheless, clinical data on ARDS are still limited, most of them derived from small clinical trials in which variable outdated APRV settings were used, consequently, the findings of these studies were controversial.

Additionally, the previous single-centre,random control study showed that clinical benefit for APRV.Therefore,the investigators are ready to design a multiple centres,random control study to further verify the effect of APRV plus protocol in ARDS.


Condition or disease Intervention/treatment Phase
Acute Respiratory Distress Syndrome Procedure: APRVplus protocol Procedure: Low tidal volume ventilation Not Applicable

Detailed Description:
All the patients included will be randomly assigned to receiving APRV plus protocol or low tidal volume ventilation.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Multiple Centre,Random Control Study :Early Use of Airway Pressure Release Ventilation Updated (APRV Plus) Protocol in Acute Respiratory Disease Syndrome (ARDS)
Estimated Study Start Date : August 20, 2018
Estimated Primary Completion Date : August 20, 2020
Estimated Study Completion Date : December 1, 2020


Arm Intervention/treatment
Experimental: Early use of APRVplus protocol in ARDS
physiology-driven APRVplus protocol
Procedure: APRVplus protocol
Physiology-driven APRVplus protocol

Low tidal volume ventilation
Low tidal volume lung protective ventilation
Procedure: Low tidal volume ventilation
Low tidal volume lung protective ventilation




Primary Outcome Measures :
  1. mortality [ Time Frame: Day 28 ]
    mortality at Day28


Secondary Outcome Measures :
  1. Mechanical ventilation free days [ Time Frame: Day 28 ]
    Mechanical ventilation free days at Day28

  2. oxygenation [ Time Frame: from enrollment to Day7 ]
    oxygenation index:PaO2:fiO2

  3. repiratory system compliance [ Time Frame: from enrollment to Day7 ]
    static repiratory system compliance (ml/cmH2O)

  4. MAP [ Time Frame: during the mechanical ventilation procedure ]
    mean arterial pressure

  5. sedation depth [ Time Frame: during the mechanical ventilation procedure ]
    RASS scores

  6. Sedative drug [ Time Frame: during the mechanical ventilation procedure ]
    the total dose of Sedative drug

  7. successful extubation rate [ Time Frame: during the mechanical ventilation procedure ]
    the rate of successful extubation


Other Outcome Measures:
  1. adverse events related to mechanical ventilation [ Time Frame: during the mechanical ventilation procedure ]
    including pneumothorax,VAP,and so on



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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:

  • Moderate and severe acute respiratory distress syndrome,according to the Berlin definition of ARDS
  • receiving tracheal intubation and mechanical ventilation was no longer than 48 hours

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)
  • Terminal stage of disease
  • Pneumothorax (drained or not)at enrollment
  • Treatment with extracorporeal support (ECMO) at enrollment
  • There was a lack of commitment to life support.

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): NCT03549910


Contacts
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Contact: Yongfang Zhou 86 18140212276 zyfmg@163.com
Contact: Yan Kang 86 18980601566 kang_yan_123@163.com

Sponsors and Collaborators
West China Hospital
Investigators
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Study Chair: Kang Yan Department of Critical Care Medicine

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Responsible Party: Kang Yan, Director of department of Critical Care Medicine, West China Hospital
ClinicalTrials.gov Identifier: NCT03549910     History of Changes
Other Study ID Numbers: Huaxi ICU-APRV
First Posted: June 8, 2018    Key Record Dates
Last Update Posted: June 8, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Syndrome
Respiratory Tract Diseases
Infant, Newborn, Diseases
Acute Lung Injury
Disease
Pathologic Processes
Lung Diseases
Respiration Disorders
Infant, Premature, Diseases
Lung Injury