drugset / Trial / NCT02471521

Optimal Inspiratory Pressure for Facemask Pressure-controlled Ventilation in Children

NCT02471521 ↗

Completed 120 enrolled Seoul National University Hospital
RandomizedParallel-groupSingle-blindDiagnostic

Summary

The purpose of this study is to find an optimal inspiratory pressure to provide adequate tidal volume and prevent gastric insufflation in pediatric patients. The children under 5 years old are randomly assigned to muscle relaxation group and non-relaxation group. For muscle relaxation group, routine anesthesia induction is performed with muscle relaxant and mask ventilation is started by pressure-controlled mechanical ventilation. Gastric auscultation and abdominal ultrasonography are performed simultaneously during mask ventilation to detect inflow of air. Initial inspiratory airway pressure is 10 cmH2O and increased gradually by 2 cmH2O until gastric insufflation is detected by either of two methods. Tracheal intubation is done after detection of gas. For non-relaxation group, mask ventilation is performed in a same manner, without muscle relaxant. After detection of gas by any of the two methods, rocuronium 0.6 mg/kg is administered and tracheal intubation is performed.

Timeline

Start
2015-02
Primary completion
2015-12
Completion
2015-12

Outcome

Missed primary endpoint

paper There was no significant difference in the median [interquartile range] inspiratory pressure inducing gastric insufflation between the non-NM (n = 52) and NM groups (n = 60) PMID 29998359 ↗

paper median difference, 0 cmH2O; 95% confidence interval [CI], 0 to 2; P = 0.57 PMID 29998359 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Rocuronium Other / unclassified 0.6 mg/kg —

Indications

No indication recorded.