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.

Study Overview

• Status: Unknown
• Conditions: Respiratory Distress Syndrome, Adult; Respiration, Artificial
• Intervention / Treatment: Procedure: type of mechanical ventilation

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)

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Chandigarh, India, 160012
    • Recruiting
    • Respiratory intensive care unit, PGIMER
    • Contact: Ritesh Agarwal, MD, DM, MAMS, FCCP; Phone Number: 2756825 9914209825; Email: riteshpgi@gmail.com
    • Principal Investigator: Arjun Srinivasan, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Mortality	up to 8 weeks
ease of use of ventilator mode	up to 4 weeks
frequency of blood gas analysis	up to 4 weeks

Collaborators and Investigators

• Sponsor: Postgraduate Institute of Medical Education and Research
• Investigators: Principal Investigator: Arjun srinivasan, M.D., dept of pulmonary medicine & critical care, PGIMER

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Anticipated): June 1, 2011

Study Registration Dates

• First Submitted: July 16, 2010
• First Submitted That Met QC Criteria: July 19, 2010
• First Posted (Estimate): July 20, 2010

Study Record Updates

• Last Update Posted (Estimate): July 20, 2010
• Last Update Submitted That Met QC Criteria: July 19, 2010
• Last Verified: December 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Disease; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Syndrome; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: ASVtrial