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N/A N=120 Randomized Single-blind Diagnostic

Optimal Inspiratory Pressure for Facemask Pressure-controlled Ventilation in Children

Child · Anesthesia

Enrolled (actual)
120
Serious AEs
0.0%
Results posted
Jan 2019
Primary outcome: Primary: Inspiratory Pressure That Cause Gastric Insufflation — 13; 13 cmH2O

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Mask ventilation (Other); Rocuronium (Drug)
Age
Pediatric · 0+ yrs
Sex
All
Sponsor
Seoul National University Hospital
Primary completion
Dec 2015

Outcome Measures

OutcomeResultp-value
PRIMARY
Inspiratory Pressure That Cause Gastric Insufflation
13; 13
SECONDARY
Diagnostic Method That Detects Gastric Insufflation First
44; 23; 4; 10; 12; 19

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.

Eligibility Criteria

Inclusion Criteria

  • Pediatric patients scheduled for elective surgery under general anesthesia
  • BMI < 30
  • ASA class 1 or 2

Exclusion Criteria

  • with difficult airway
  • preexisting pulmonary disease
  • upper respiratory tract infection
  • intestinal obstruction
  • with risk of pulmonary aspiration
  • history of stoke or moyamoya disease
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02471521). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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