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Adaptive Support Ventilation in Acute Respiratory Distress Syndrome (ARDS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by Postgraduate Institute of Medical Education and Research.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier:
NCT01165528
First received: July 16, 2010
Last updated: July 19, 2010
Last verified: December 2009
History of Changes
  Purpose

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.


Condition Intervention
Respiration, Artificial
Respiratory Distress Syndrome, Adult
 Procedure: type of mechanical ventilation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Adaptive Support Ventilation vs. Conventional Ventilation Strategy in the Management of Acute Respiratory Distress Syndrome:A Randomized Controlled Trial

Further study details as provided by Postgraduate Institute of Medical Education and Research:

Primary Outcome Measures:
  • Duration of mechanical ventilation [ Time Frame: up to 4 weeks ] [ Designated as safety issue: No ]
  • duration of ICU stay [ Time Frame: up to 4 weeks ] [ Designated as safety issue: No ]
  • duration of hospital stay [ Time Frame: up to 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mortality [ Time Frame: up to 8 weeks ] [ Designated as safety issue: Yes ]
  • ease of use of ventilator mode [ Time Frame: up to 4 weeks ] [ Designated as safety issue: No ]
  • frequency of blood gas analysis [ Time Frame: up to 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: January 2010
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Adaptive support ventilation in ARDS
patients of ARDS will be randomized to this arm to receive mechanical ventilation as per ASV protocol
 Procedure: type of mechanical ventilation
patients are randomized to receive one of the two types of mechanical ventilation for ARDS
Active Comparator: conventional ventilation strategy in ARDS Procedure: type of mechanical ventilation
patients are randomized to receive one of the two types of mechanical ventilation for ARDS

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.

  1. Acute onset shortness of breath(<7 days)
  2. PaO2/FiO2 < 200 mm Hg (regardless of PEEP)
  3. Bilateral infiltrates on frontal chest radiograph
  4. <18 mm Hg when measured or no clinical evidence of left atrial hypertension

Exclusion criteria:

  1. Age less than 12 years
  2. Patients having underlying chronic lung disease (COPD, interstitial lung disease, pulmonary hypertension)
  3. 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)
  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01165528

Locations
India
Respiratory intensive care unit, PGIMER Recruiting
Chandigarh, India, 160012
Contact: Ritesh Agarwal, MD, DM, MAMS, FCCP     9914209825 ext 2756825     riteshpgi@gmail.com    
Principal Investigator: Arjun Srinivasan, M.D.            
Sponsors and Collaborators
Postgraduate Institute of Medical Education and Research
Investigators
Principal Investigator: Arjun srinivasan, M.D. dept of pulmonary medicine & critical care, PGIMER
  More Information

No publications provided

Responsible Party: Dr. Arjun Srinivasan, senior resident, Dept of Pulmonary medicine & critical care, PGIMER
ClinicalTrials.gov Identifier: NCT01165528     History of Changes
Other Study ID Numbers: ASVtrial
Study First Received: July 16, 2010
Last Updated: July 19, 2010
Health Authority: India: Institutional Review Board

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
 Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury

ClinicalTrials.gov processed this record on May 22, 2013