Volume Guarantee Versus Manual Tidal Volume Monitoring During High‐Frequency Oscillatory Ventilation in Neonates: A Pilot Randomized Controlled Trial

Objective The present study compared the effects of high‐frequency oscillatory ventilation (HFOV) with automated volume guarantee (HFOV‐VG) versus careful manual high‐frequency tidal volume (VThf) monitoring (HFOV‐VM) on the incidences of hypo/hypercarbia in neonates. Methods In this open‐labeled, parallel‐group randomized controlled trial, 60 neonates failing conventional mechanical ventilation were allocated to receive HFOV‐VG ( n = 30) versus HFOV‐VM ( n = 30) as a rescue mode. The primary outcome was the incidence of hypo/hypercarbia at 1 h. Secondary outcomes were incidences of hypo/hypercarbia at 6/12/24/48 h and beyond, time‐specific trends for partial pressure of carbon dioxide (pCO 2 ), delivered VThf and mean airway pressure (MAP), cerebral blood flow (CBF) in the anterior cerebral artery (ACA) and regional cerebral oxygenation (CrSO 2 ), duration of respiratory support, and incidences of in‐hospital adverse events. Stata 18 was used for an intention‐to‐treat analysis. Results The incidence of hypo‐ or hypercarbia at 1 h of intervention was 15/30 (50%) in the HFOV‐VG and 13/30 (43%) in the HFOV‐VM groups ( p = 0.61). No differences were observed in the incidences of hypo‐ or hypercarbia anytime during HFOV. Time‐specific pCO 2 , VThf, and MAP were similar. On regression analysis, the only significant predictor for pCO 2 at 1 h was the baseline pCO 2 level in both the groups. No difference was observed in ACA‐CBF, CrSO 2 , duration of respiratory support, and in‐hospital adverse events including mortality. Conclusion There was no difference in the incidence of hypo/hypercarbia with HFOV‐VG versus HFOV‐VM at 1 h and throughout the duration of ventilation with a similar rate of complications when used as a rescue therapy. Trial Registration Clinical trial registry of India, Registration no: CTRI/2024/09/073455, Registered prospectively on 05/09/2024, https://ctri.icmr.org.in/