Back to resultsA Multiple Centre,Random Control Study :Early Use of Airway Pressure Release Ventilation (APRV) Plus Protocol in ARDS
Primary Purpose
Acute Respiratory Distress Syndrome
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
APRVplus protocol
Low tidal volume ventilation
Sponsored by
About this trial
This is an interventional supportive care trial for Acute Respiratory Distress Syndrome
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Early use of APRVplus protocol in ARDS
Low tidal volume ventilation
Arm Description
physiology-driven APRVplus protocol
Low tidal volume lung protective ventilation
Outcomes
Primary Outcome Measures
mortality
mortality at Day28
Secondary Outcome Measures
Mechanical ventilation free days
Mechanical ventilation free days at Day28
oxygenation
oxygenation index:PaO2:fiO2
repiratory system compliance
static repiratory system compliance (ml/cmH2O)
MAP
mean arterial pressure
sedation depth
RASS scores
Sedative drug
the total dose of Sedative drug
successful extubation rate
the rate of successful extubation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03549910
Brief Title
A Multiple Centre,Random Control Study :Early Use of Airway Pressure Release Ventilation (APRV) Plus Protocol in ARDS
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)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 20, 2018 (Anticipated)
Primary Completion Date
August 20, 2020 (Anticipated)
Study Completion Date
December 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
West China Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
All the patients included will be randomly assigned to receiving APRV plus protocol or low tidal volume ventilation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Distress Syndrome
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Early use of APRVplus protocol in ARDS
Arm Type
Experimental
Arm Description
physiology-driven APRVplus protocol
Arm Title
Low tidal volume ventilation
Arm Type
Other
Arm Description
Low tidal volume lung protective ventilation
Intervention Type
Procedure
Intervention Name(s)
APRVplus protocol
Intervention Description
Physiology-driven APRVplus protocol
Intervention Type
Procedure
Intervention Name(s)
Low tidal volume ventilation
Intervention Description
Low tidal volume lung protective ventilation
Primary Outcome Measure Information:
Title
mortality
Description
mortality at Day28
Time Frame
Day 28
Secondary Outcome Measure Information:
Title
Mechanical ventilation free days
Description
Mechanical ventilation free days at Day28
Time Frame
Day 28
Title
oxygenation
Description
oxygenation index:PaO2:fiO2
Time Frame
from enrollment to Day7
Title
repiratory system compliance
Description
static repiratory system compliance (ml/cmH2O)
Time Frame
from enrollment to Day7
Title
MAP
Description
mean arterial pressure
Time Frame
during the mechanical ventilation procedure
Title
sedation depth
Description
RASS scores
Time Frame
during the mechanical ventilation procedure
Title
Sedative drug
Description
the total dose of Sedative drug
Time Frame
during the mechanical ventilation procedure
Title
successful extubation rate
Description
the rate of successful extubation
Time Frame
during the mechanical ventilation procedure
Other Pre-specified Outcome Measures:
Title
adverse events related to mechanical ventilation
Description
including pneumothorax,VAP,and so on
Time Frame
during the mechanical ventilation procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yongfang Zhou
Phone
86 18140212276
Email
zyfmg@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yan Kang
Phone
86 18980601566
Email
kang_yan_123@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kang Yan
Organizational Affiliation
Department of Critical Care Medicine
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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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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