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Status unknownNCT01165528Updated Jul 20, 2010

Adaptive Support Ventilation in Acute Respiratory Distress Syndrome (ARDS)

An interventional study of type of mechanical ventilation in Respiration, Artificial and Respiratory Distress Syndrome, Adult, sponsored by Post Graduate Institute of Medical Education and Research, Chandigarh. Status unknown at 1 site in India. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2010-07-20.

Sponsored by Post Graduate Institute of Medical Education and Research, Chandigarh · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2009), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
12 Years and older
Sex
All
01

Study 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.

Read the 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)
02

Conditions studied

  • Respiration, Artificial
  • Respiratory Distress Syndrome, Adult
03

In context

Respiratory Distress Syndrome

1,597 studies on the registry are indexed under Respiratory Distress Syndrome; 312 are open to participants now.

This study's planned enrollment of 40 is below the median of 60 across 961 interventional studies indexed under Respiratory Distress Syndrome.

Browse Respiratory Distress Syndrome studies →

Lead sponsor

Post Graduate Institute of Medical Education and Research, Chandigarh is the lead sponsor of 290 studies on the registry; 42 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • 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

  • Active comparator
    conventional ventilation strategy in ARDS

    Procedure: type of mechanical ventilation

Interventions

  • Proceduretype of mechanical ventilation

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

06

What researchers measure

Primary outcomes

  1. Duration of mechanical ventilation

    Time frame: up to 4 weeks

  2. duration of ICU stay

    Time frame: up to 4 weeks

  3. duration of hospital stay

    Time frame: up to 8 weeks

Secondary outcomes

  1. Mortality

    Time frame: up to 8 weeks

  2. ease of use of ventilator mode

    Time frame: up to 4 weeks

  3. frequency of blood gas analysis

    Time frame: up to 4 weeks

07

Study locations

1 of 1 sites recruiting
  • Respiratory intensive care unit, PGIMER
    Chandigarh, 160012, India
    • Ritesh Agarwal, MD, DM, MAMS, FCCP · Contact · riteshpgi@gmail.com · 9914209825
    • Arjun Srinivasan, M.D. · Principal investigator
    Recruiting
08

References and documents

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. PubMed 23711230 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 20, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01165528
Lead sponsor
Post Graduate Institute of Medical Education and Research, Chandigarh
First posted
Jul 20, 2010
Start date
Jan 2010
Primary completion
Jun 2011 (estimated)
Last update
Jul 20, 2010

Study contacts

Arjun srinivasan, M.D.
principal investigator · dept of pulmonary medicine & critical care, PGIMER

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2009. You cannot join it, but the record below documents what was studied.

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