Comparison between two ventilatory modes in reducing the days of mechanical ventilation and also assosciated complications.
- Conditions
- Prematurely born newborns with Respiratory distress syndrome
- Registration Number
- CTRI/2017/11/010439
- Brief Summary
Mechanical ventilation still remains as the mainstay ofmanagement in newborns with respiratory distress syndrome (RDS). The ventilatedpreterm infant lungs are vulnerable to overdistention and underinflation. Modernneonatal ventilators has volume targeted modes alternative to traditionalpressure limited ventilation, which aims to deliver a more stable tidal volumethereby reducing volutrauma and atlectotrauma. OBJECTIVE: To determine whether volume targetedventilation compared with pressure limited ventilation reduces the time toreach weaning criteria in prematurely born infants with RDS. METHOD: This is a randomized control trial of neonates who havebeen mechanically ventilated in NICU, Kasturba Hospital Manipal Udupi. Infantsof less than 34 weeks with RDS requiring mechanical ventilation in first weekof life were randomized to receive either pressure limited ventilation (PLV) orvolume targeted ventilation (VTV). The primary outcome was the time to achieveprespecified weaning criteria. Secondary outcomes assessed was incidence of Pneumothorax,Retinopathy Of Prematurity (ROP), Intraventricular Haemorrhage (IVH),Necrotizing Enterocolitis (NEC), Periventricular leukomalacia (PVL) and total ventilatory hours. RESULT: 81 neonates were enrolled and randomized into two treatmentgroups. The mean gestational age and birth weight of treatment group were 30 (±2.3)and 1230 (±374) gm and 70% of them received antenatal steroids. The primaryoutcome variable time to achieve weaning criteria was 8 hrs (3-17)(median andIQR) in PLV and 6 hrs (3- 13) in VTV (P=0.366), However in stratified analysisof infants in 31-34 weeks of GA there was a significant difference in primaryoutcomes, 10 hrs (5-14) in PLV and 5 hrs (2-12) in VTV (p=0.039). Thecomplications associated with ventilation were compared and analysed betweenthe groups.. CONCLUSION: In prematurely born infants with respiratory distress syndrome requiringmechanical ventilation, the use of VTV showed to be at par with the standardPLV. This could enable us to use it more confidently as a primary mode withlower limit of tidal volume. But in order to substantiate this further RCT maybe required.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 130
- 1 Neonates with congenital cyanotic heart diseases.
- 2 Neonates with major congenital malformations.
- 3 Neonates with air leak syndromes.
- 4 Neonates requiring High Frequency Oscillatory Ventilation (HFOV).
- 1.Neonates with congenital cyanotic heart diseases.
- 2.Neonates with major congenital malformations.
- 3.Neonates with air leak syndromes.
- 4.Neonates requiring High Frequency Oscillatory Ventilation (HFOV).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary outcome is to compare the time required to reach the weaning criteria assessed by volume targeted ventilation to pressure limited ventilation in prematurely born infants. At the time of extubation
- Secondary Outcome Measures
Name Time Method 1 Rate of failure 2 Oxygenation Index at 6th hourly
Trial Locations
- Locations (1)
Kasturba hospital
🇮🇳Udupi, KARNATAKA, India
Kasturba hospital🇮🇳Udupi, KARNATAKA, Indiagokul krishna gPrincipal investigator9108598185gokulrescare@gmail.com