Utility of Spontaneous Breathing Trial (SBT) Using ET-CPAP, in Predicting Extubation Failure in Neonates
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ClinicalTrials.gov Identifier: NCT03091387
Recruitment Status : Unknown
Verified March 2017 by Ali S. Hussain, Aga Khan University. Recruitment status was: Not yet recruiting
Intubation and ventilation are lifesaving interventions in the neonatal intensive care unit (ICU), especially among preterm, low birth weight babies. However, timely extubation is also necessary. The decision to extubate usually depends on clinical judgement, appropriate blood gas prior to extubation and low ventilator parameters. Approximately 40 % of babies' extubated on the above criteria require re-intubation, suggesting that current methods to predict extubation failure are insufficient. . Spontaneous breathing trial (SBT) has been predominantly used in infants and children to access the readiness for extubation. Few studies in premature neonates have also shown good sensitivity and specificity in predicting extubation success. However its significance in our population is yet to be determined. We aim to use this for both our preterm and term babies and if results are significant we plan to include this as our routine pre extubation criteria.
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Layout table for eligibility information
Ages Eligible for Study:
up to 3 Months (Child)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Neonates on mechanical ventilation in NICU.
1. Neonates who are intubated for more than 24 hrs. AND 2. Extubation is planned by the primary team onto Nasal continuous positive airway pressure (NCPAP) for weight < 1.5 kg OR Oxygen via nasal prongs for weight ≥ 1.5 kg
AND having all of the following:
Pre extubation blood gas pH=7.25-7.45 and PCo2=35-45mmHg
Pre extubation fractional inspiration of oxygen (FiO2)=<40%
Is off sedation medication for >4 hrs
I-time= 0.3-0.36 sec
Peep: 5 cm h20
VTe: >3 ml/kg
Breathing rate above the set ventilator rate
4. Family providing written informed consent
Neonates who will be extubated and kept on other modalities like high flow nasal cannula.
Congenital malformation like lung hypoplasia/diaphrgmatic hernia/congenital cyanotic heart disease.