Trial of an alternate mode of providing artificial breaths to children with very severe pneumonia
- Conditions
- Health Condition 1: null- Acute respiratory distress syndrome (ARDS)/ Acute Lung Injury
- Registration Number
- CTRI/2014/06/004677
- Lead Sponsor
- Indian Council Of Medical Research ICMR New Delhi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 100
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 â?? 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
Children with the following conditions would be excluded:
(i)Greater than 24 hours since diagnosis of ARDS
(ii)Co-existing raised intra-cranial pressure/ any other condition necessitating use of high dose of sedation (likely to suppress spontaneous breathing)
(iii)Radiologically confirmed air leak prior to randomization â?? Pneumothorax/ Pulmonary interstitial Emphysema
(iv)Clinical evidence of significant airway obstruction/ severe bronchospasm / reactive airway disease
(v)Have received mechanical ventilation for more than 72 hours (before meeting inclusion criteria 1-5)
(vi)Symptomatic or uncorrected congenital heart disease or a right to left intra-cardiac shunt
(vii)Any underlying condition that is likely to impair spontaneous respiratory drive/ efforts (Eg: Brainstem dysfunction, neuromuscular paralysis)
(viii)Underlying chronic diseases (Eg: Cystic fibrosis, Chronic lung disease, etc)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Twenty eight-day ventilator-free daysTimepoint: 28 days
- Secondary Outcome Measures
Name Time Method