Adaptive Support Ventilation in Acute Respiratory Distress Syndrome (ARDS)

NCT01165528 | Unknown

• 1 other identifier: ASVtrial
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiration, Artificial; Respiratory Distress Syndrome, Adult

Outcome Measures

Primary Outcomes (3)

• Duration of mechanical ventilation

  up to 4 weeks

• duration of ICU stay

  up to 4 weeks

• duration of hospital stay

  up to 8 weeks

Secondary Outcomes (3)

• Mortality

  up to 8 weeks

• ease of use of ventilator mode

  up to 4 weeks

• frequency of blood gas analysis

  up to 4 weeks

Study Arms (2)

Adaptive support ventilation in ARDS

ACTIVE COMPARATOR

patients of ARDS will be randomized to this arm to receive mechanical ventilation as per ASV protocol

Procedure: type of mechanical ventilation

conventional ventilation strategy in ARDS

ACTIVE COMPARATOR

Procedure: type of mechanical ventilation

Interventions

type of mechanical ventilation PROCEDURE

patients are randomized to receive one of the two types of mechanical ventilation for ARDS

Adaptive support ventilation in ARDS; conventional ventilation strategy in ARDS

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Study Sites (1)

Respiratory intensive care unit, PGIMER

Chandigarh, Chandigarh, 160012, India

RECRUITING

Related Publications (1)

• 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.

  PMID: 23711230 DERIVED

MeSH Terms

Conditions

Respiratory Aspiration; Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lung Diseases

Study Officials

• Arjun srinivasan, M.D.

  dept of pulmonary medicine & critical care, PGIMER

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 16, 2010
• First Posted: July 20, 2010
• Study Start: January 1, 2010
• Primary Completion: June 1, 2011
• Last Updated: July 20, 2010

Record last verified: 2009-12

Locations

IN (1)