N/A
N=120
Optimal Inspiratory Pressure for Facemask Pressure-controlled Ventilation in Children
Child · Anesthesia
Bottom Line
View on ClinicalTrials.gov: NCT02471521 ↗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
| Outcome | Result | p-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
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.