Trial of an Alternate Mode of Providing Artificial Breaths to Children With Very Severe Pneumonia

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.

Conditions

• Acute Respiratory Distress Syndrome (ARDS)

Interventions

DEVICE

Airway Pressure Release Ventilation (APRV)

This is a newer mode of ventilation that has been hypothesized to be equivalent or even superior to the conventional low-tidal volume mode of ventilation

OTHER

Low-tidal volume ventilation

This mode of ventilation is the standard of care worldwide for ventilating children with ARDS.

DRUG

Methylprednisolone

Children with primary ARDS presenting within the first 14 days would receive IV low dose Methylprednisolone infusion.

OTHER

Restrictive fluid therapy

Fluid \& hemodynamics would be titrated as per pre-designed decision-making protocols

DRUG

sedo-analgesia titration

OTHER

Protocolized early enteral nutrition

Early enteral nutrition and attempt to meet calorie-protein goals

OTHER

Protocolized supportive care

Eye care, chlorhexidine mouth wash Q6 hourly, Strict aseptic precautions prior to any procedures, Skin care \& bed sore prevention, Adequate pulmonary toileting and chest physiotherapy, frequent position changes, limb physiotherapy, family-centered care

OTHER

Biomarker Assay

Biomarker Assay for patients in both arms

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh

  lead OTHER

Principal Investigators

• Saptharishi L G, MBBS, MD · DM (Pediatric Critical Care) Senior Resident, Division of Pediatric critical care, Dept Of Pediatrics, Advanced Pediatrics Center, PGIMER, Chandigarh, INDIA

• Jayashree Muralidharan, MBBS, MD · Additional Professor, Division of Pediatric critical care, Dept of Pediatrics, Advanced Pediatrics Center, PGIMER, Chandigarh, India

• Sunit C Singhi, MBBS, MD · Chief, Division of Pediatric Critical Care, Professor & Head, Department of Pediatrics, Advanced Pediatrics Center, PGIMER, Chandigarh, India

• Arun Bansal, MBBS, MD · Assistant Professor, Division of Pediatric Critical care, Dept of Pediatrics, Advanced Pediatrics Center, PGIMER, Chandigarh, India

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

1 Month

Max Age

12 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-02-28

Primary Completion

2016-06-30

Completion

2016-12-31

Countries

• India

Study Locations