Adaptive Support Ventilation in Acute Respiratory Distress Syndrome (ARDS)

Respiratory Distress Syndrome, Adult Clinical Trial

Official title:

Adaptive Support Ventilation vs. Conventional Ventilation Strategy in the Management of Acute Respiratory Distress Syndrome:A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01165528
• Other study ID #: ASVtrial
• Status: Recruiting
• Phase: N/A
• First received: July 16, 2010
• Last updated: July 19, 2010
• Start date: January 2010

Study information

• Verified date: December 2009
• Source: Postgraduate Institute of Medical Education and Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Lung Injury
• Respiration, Artificial
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Syndrome

Intervention

Procedure:
• type of mechanical ventilation
patients are randomized to receive one of the two types of mechanical ventilation for ARDS

Locations

Country	Name	City	State
India	Respiratory intensive care unit, PGIMER	Chandigarh

Sponsors (1)

Lead Sponsor	Collaborator
Postgraduate Institute of Medical Education and Research

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of mechanical ventilation		up to 4 weeks	No
Primary	duration of ICU stay		up to 4 weeks	No
Primary	duration of hospital stay		up to 8 weeks	No
Secondary	Mortality		up to 8 weeks	Yes
Secondary	ease of use of ventilator mode		up to 4 weeks	No
Secondary	frequency of blood gas analysis		up to 4 weeks	No