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
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.
Exclusion criteria:
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 →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.
Exclusion Criteria:
patients of ARDS will be randomized to this arm to receive mechanical ventilation as per ASV protocol
Procedure: type of mechanical ventilation
Procedure: type of mechanical ventilation
patients are randomized to receive one of the two types of mechanical ventilation for ARDS
Duration of mechanical ventilation
Time frame: up to 4 weeks
duration of ICU stay
Time frame: up to 4 weeks
duration of hospital stay
Time frame: up to 8 weeks
Mortality
Time frame: up to 8 weeks
ease of use of ventilator mode
Time frame: up to 4 weeks
frequency of blood gas analysis
Time frame: up to 4 weeks
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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Respiratory Distress Syndrome→
Post Graduate Institute of Medical Education and Research, Chandigarh