Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT02167698 : Trial of an Alternate Mode of Providing Artificial Breaths to Children With Very Severe Pneumonia
PhaseN/A
AgesMin: 1 Month Max: 12 Years
Eligibility
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)
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02167698      |      Link to official Clinicaltrials.gov listing
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