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

July 16, 2010
July 19, 2010
January 2010
June 2011   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01165528 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Adaptive Support Ventilation in Acute Respiratory Distress Syndrome (ARDS)
Adaptive Support Ventilation vs. Conventional Ventilation Strategy in the Management of Acute Respiratory Distress Syndrome:A Randomized Controlled Trial

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.

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)
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Respiration, Artificial
  • Respiratory Distress Syndrome, Adult
Procedure: type of mechanical ventilation
patients are randomized to receive one of the two types of mechanical ventilation for ARDS
  • Active Comparator: Adaptive support ventilation in ARDS
    patients of ARDS will be randomized to this arm to receive mechanical ventilation as per ASV protocol
    Intervention: Procedure: type of mechanical ventilation
  • Active Comparator: conventional ventilation strategy in ARDS
    Intervention: Procedure: type of mechanical ventilation
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
Not Provided
June 2011   (final data collection date for primary outcome measure)

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)
Both
12 Years and older
No
India
 
NCT01165528
ASVtrial
No
Dr. Arjun Srinivasan, senior resident, Dept of Pulmonary medicine & critical care, PGIMER
Postgraduate Institute of Medical Education and Research
Not Provided
Principal Investigator: Arjun srinivasan, M.D. dept of pulmonary medicine & critical care, PGIMER
Postgraduate Institute of Medical Education and Research
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP