Trial of an Alternate Mode of Providing Artificial Breaths to Children With Very Severe Pneumonia
Status:
Terminated
Trial end date:
2016-12-01
Target enrollment:
Participant gender:
Summary
This study attempts to study a new ventilation mode in children with Acute respiratory
distress syndrome (ARDS). Despite decades of research, no intervention has brought about a
significant decrease in ARDS mortality. Moreover, most of the studies are adult-based and
have been extrapolated to children. Airway pressure release ventilation (APRV) mode is
hypothesized to be superior in terms of lower need for sedation, shorter duration of
mechanical ventilation, etc. It is unique and the first worldwide randomized controlled trial
on APRV mode in children.
We plan to recruit a minimum of 50 children aged (1 month-12 years) in each group. The study
is to be conducted at the Post-Graduate Institute of Medical Education and Research (PGIMER),
Chandigarh between March 2014 to March 2016. This trial would recruit children with
respiratory failure and early ARDS and, randomize them to receive either conventional
ventilation or the APRV mode. Rest of the supportive care has also been protocolized so that
both groups receive treatment as per the existing best practices in every aspect. The primary
outcome being studied is the number of ventilator-free days. The secondary outcomes include
length of PICU stay, hospital stay, organ-failure free days, 28 day & 3 month survival,
biomarkers of lung injury (IL-6, IL-8, Angiopoeitin-2, soluble-ICAM-1, etc), functional
status, Pulmonary function tests, etc. Funding request would be sent to the Indian Council of
Medical Research, New Delhi, India.
Assessing lung biomarkers like Interleukin-6 would assess the role of different modes of
ventilation in acting as triggers for multi-organ dysfunction as well as for worsening lung
injury. This pathbreaking research is likely to open up new avenues upon completion.
Phase:
N/A
Details
Lead Sponsor:
Postgraduate Institute of Medical Education and Research