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: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Postgraduate Institute of Medical Education and Research
• Treatments: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

Inclusion Criteria:

• Children aged 1 month- 12 years, who are intubated and mechanically ventilated with the following criteria of Acute Respiratory Distress Syndrome:

1. Acute presentation within 1 week of a known clinical insult or new/ worsening respiratory symptoms

2. Bilateral opacities on chest imaging - not fully explained by effusions, lobar/lung collapse, or nodules

3. Respiratory failure is not fully explained by cardiac failure or fluid overload (Echocardiographic assessment to exclude hydrostatic edema)

4. Impaired oxygenation with PaO2/ FiO2 ratio less than 300 or Oxygenation Index greater than 5.3

Exclusion Criteria:

• Greater than 24 hours since diagnosis of ARDS

• Co-existing raised intra-cranial pressure/ any other condition necessitating use of high dose of sedation (likely to suppress spontaneous breathing)

• Radiologically confirmed air leak prior to randomization - Pneumothorax/ Pulmonary interstitial Emphysema

• Clinical evidence of significant airway obstruction/ severe bronchospasm / reactive airway disease

• Have received mechanical ventilation for more than 72 hours (before meeting inclusion criteria)

• Symptomatic or uncorrected congenital heart disease or a right to left intra-cardiac shunt

• Any underlying condition that is likely to impair spontaneous respiratory drive/ efforts (Eg: Brainstem dysfunction, neuromuscular paralysis)

• Underlying chronic diseases (Eg: Cystic fibrosis, Chronic lung disease, etc)