Adaptive Support Ventilation in Acute Respiratory Distress Syndrome (ARDS)
Primary Purpose
Respiration, Artificial, Respiratory Distress Syndrome, Adult
Status
Unknown status
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
type of mechanical ventilation
Sponsored by
About this trial
This is an interventional treatment trial for Respiration, Artificial
Eligibility Criteria
Inclusion Criteria:
- Acute onset shortness of breath(<7 days)
- PaO2/FiO2 < 200 mm Hg (regardless of PEEP)
- Bilateral infiltrates on frontal chest radiograph
- <18 mm Hg when measured or no clinical evidence of left atrial hypertension
Exclusion Criteria:
- Age less than 12 years
- Patients having underlying chronic lung disease
- Contraindication to permissive hypercapnia (raised intracranial pressure, acute cerebrovascular disorders, acute or chronic myocardial ischemia, right ventricular failure, uncorrected severe metabolic acidosis, sickle cell anemia, tricyclic antidepressant overdose, pregnancy)
Sites / Locations
- Respiratory intensive care unit, PGIMERRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Adaptive support ventilation in ARDS
conventional ventilation strategy in ARDS
Arm Description
patients of ARDS will be randomized to this arm to receive mechanical ventilation as per ASV protocol
Outcomes
Primary Outcome Measures
Duration of mechanical ventilation
duration of ICU stay
duration of hospital stay
Secondary Outcome Measures
Mortality
ease of use of ventilator mode
frequency of blood gas analysis
Full Information
NCT ID
NCT01165528
First Posted
July 16, 2010
Last Updated
July 19, 2010
Sponsor
Postgraduate Institute of Medical Education and Research
1. Study Identification
Unique Protocol Identification Number
NCT01165528
Brief Title
Adaptive Support Ventilation in Acute Respiratory Distress Syndrome (ARDS)
Official Title
Adaptive Support Ventilation vs. Conventional Ventilation Strategy in the Management of Acute Respiratory Distress Syndrome:A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2009
Overall Recruitment Status
Unknown status
Study Start Date
January 2010 (undefined)
Primary Completion Date
June 2011 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Postgraduate Institute of Medical Education and Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Prospective randomized controlled trial to be conducted in the Respiratory Intensive Care Unit (RICU) of Post Graduate Institute of Medical Education And Research (PGIMER),Chandigarh. The study is approved by the Institute Ethics committee. In view of lack of previous outcome data in such patients, all patients requiring RICU admission for acute respiratory distress syndrome(ARDS) between January 2010 and June 2011 are being enrolled in this pilot study.
The patients meeting the aforementioned criteria will randomly assigned to ventilation with assist control mode ventilation (ACMV group) as per the ARDSnet strategy or adaptive support ventilation (ASV group). Being the first RCT of its type, patients will be first stabilized on ACMV for 1 hour to determine the adequate minute ventilation. The randomization sequence will be computer generated. The assignments will placed in sealed opaque envelopes and each patient's assignment was made on admission to the RICU by the attending physician. Blinding of treatment is not possible.
All patients will be ventilated only by Galileo Gold ventilators (Hamilton medical systems, Bonaduz, Switzerland). Patients randomized to the ACMV group will be ventilated according to low tidal volume strategy of 6ml/kg with Fio2/PEEP as per ARDSnet table to achieve a saturation between 88-95% with the lowest possible Fio2 to maintain plateau pressures < 30 cms H2o and PH > 7.3 with option to reduce tidal volume to 4 ml/kg and increase respiratory rate to 35/ min to achieve the above said goals11.These patients will be weaned as per standard protocol of spontaneous breathing trial of 30 minutes once they are recognized eligible as per statement of the sixth International consensus conference on weaning.
Detailed Description
Inclusion criteria:
Study to include at least 40 patients admitted to RICU with diagnosis of ARDS as defined by American European consensus committee in 1994.
Acute onset shortness of breath(<7 days)
PaO2/FiO2 < 200 mm Hg (regardless of PEEP)
Bilateral infiltrates on frontal chest radiograph
<18 mm Hg when measured or no clinical evidence of left atrial hypertension
Exclusion criteria:
Age less than 12 years
Patients having underlying chronic lung disease (COPD, interstitial lung disease, pulmonary hypertension)
Contraindication to permissive hypercapnea (raised intracranial pressure, acute cerebrovascular disorders, acute or chronic myocardial ischemia, right ventricular failure, uncorrected severe metabolic acidosis, sickle cell anemia, tricyclic antidepressant overdose, pregnancy)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiration, Artificial, Respiratory Distress Syndrome, Adult
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Adaptive support ventilation in ARDS
Arm Type
Active Comparator
Arm Description
patients of ARDS will be randomized to this arm to receive mechanical ventilation as per ASV protocol
Arm Title
conventional ventilation strategy in ARDS
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
type of mechanical ventilation
Intervention Description
patients are randomized to receive one of the two types of mechanical ventilation for ARDS
Primary Outcome Measure Information:
Title
Duration of mechanical ventilation
Time Frame
up to 4 weeks
Title
duration of ICU stay
Time Frame
up to 4 weeks
Title
duration of hospital stay
Time Frame
up to 8 weeks
Secondary Outcome Measure Information:
Title
Mortality
Time Frame
up to 8 weeks
Title
ease of use of ventilator mode
Time Frame
up to 4 weeks
Title
frequency of blood gas analysis
Time Frame
up to 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Acute onset shortness of breath(<7 days)
PaO2/FiO2 < 200 mm Hg (regardless of PEEP)
Bilateral infiltrates on frontal chest radiograph
<18 mm Hg when measured or no clinical evidence of left atrial hypertension
Exclusion Criteria:
Age less than 12 years
Patients having underlying chronic lung disease
Contraindication to permissive hypercapnia (raised intracranial pressure, acute cerebrovascular disorders, acute or chronic myocardial ischemia, right ventricular failure, uncorrected severe metabolic acidosis, sickle cell anemia, tricyclic antidepressant overdose, pregnancy)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arjun srinivasan, M.D.
Organizational Affiliation
dept of pulmonary medicine & critical care, PGIMER
Official's Role
Principal Investigator
Facility Information:
Facility Name
Respiratory intensive care unit, PGIMER
City
Chandigarh
ZIP/Postal Code
160012
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ritesh Agarwal, MD, DM, MAMS, FCCP
Phone
9914209825
Ext
2756825
Email
riteshpgi@gmail.com
First Name & Middle Initial & Last Name & Degree
Arjun Srinivasan, M.D.
12. IPD Sharing Statement
Citations:
PubMed Identifier
23711230
Citation
Agarwal R, Srinivasan A, Aggarwal AN, Gupta D. Adaptive support ventilation for complete ventilatory support in acute respiratory distress syndrome: a pilot, randomized controlled trial. Respirology. 2013 Oct;18(7):1108-15. doi: 10.1111/resp.12126.
Results Reference
derived
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Adaptive Support Ventilation in Acute Respiratory Distress Syndrome (ARDS)
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