Presented at the Neonatal Society 2017 Summer Meeting.
Chitty HE1, Tin W1, Stocken D2, Agbeko R3, Vormoor J4, Sinha SK1
1 Department of Neonatology, The James Cook University Hospital
2 Newcastle Clinical Trials Unit, Newcastle University
3 Institute of Cellular Medicine, Newcastle University
4 Northern Institute for Cancer Research, Newcastle University
Background: Despite a Cochrane review recommendation (1), different VTV modes have not been compared using clinically relevant outcomes. This randomised controlled trial (RCT) compared volume-controlled ventilation (VCV) with volume guarantee (VG) in preterm infants with respiratory distress syndrome (RDS). We hypothesised that VG would result in a 33% reduction in time to ‘readiness for extubation’ (80% power).
Methods: This RCT recruited in a tertiary neonatal unit (ISRCTN no. 04448562). The North East-York NRES Committee gave a favourable ethical opinion and the South Tees Hospitals NHS Foundation Trust provided sponsorship. Infants born at <34 weeks’ gestation (w) requiring intubation and ventilation within 24 hours (hrs) of birth were randomised to either VCV or VG delivered using Avea® ventilators. The primary outcome was an objective outcome measure representing readiness for extubation. Data were analysed by intention-to-treat using Kaplan- Meier ‘survival’ probabilities, hazard ratios (HR) and odds ratios (OR).
Results: 113 infants were enrolled (58 VCV, 55 VG). One infant was subsequently withdrawn after a postnatal diagnosis consistent with the ineligibility criteria. Mean gestational age and median birth weight in the VCV and VG groups were 27w and 1080g, and 27w and 1020g respectively. Respiratory status at entry into the trial was comparable between groups. There was no significant difference between groups in the primary outcome of duration of time to readiness for extubation (VCV 36 hrs, VG 23 hrs, HR 0.93 95% confidence interval 0.63 – 1.37) There was no significant difference in the number of infants reaching the primary outcome at 48 hrs (VCV 33, VG 34). Duration of ventilation before first extubation was similar between groups (VCV 41 hrs, VG 32, HR 0.85 95% confidence interval 0.56 – 1.27). There were no differences between trial groups in important secondary outcome measures.
Conclusion: In this trial, in preterm infants with RDS, there was no difference between VCV and VG in duration of time to readiness for extubation, or in the duration of ventilation to first extubation. Secondary outcome measures were similar irrespective of trial mode.
Corresponding author: email@example.com
1. Wheeler K, Klingenberg C, McCallion N, Morley CJ, Davis PG. Volume-targeted versus pressure-limited