Clinical trial NCT02471521: Optimal Inspiratory Pressure for Facemask Pressure-controlled Ventilation in Children
Official title: Optimal Inspiratory Pressure for Facemask Pressure-controlled Ventilation in Children: Study Using Detection of Gastric Insufflation Using Ultrasonography of the Antrum and Epigastric Auscultation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child
Anesthesia
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2015-06-15
Enrollment: 120
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed description: 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. Stratum was constructed based on age and randomization scheme was performed separately within each stratum. Block randomization was done to ensure balance of the age groups.

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.

Tidal volume and oxygen saturation are recorded during study period.

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

Primary outcomes:
measure: Inspiratory Pressure That Cause Gastric Insufflation
timeFrame: Interval between start of mask ventilation and detection of gastric insufflation, an expected average of 100 sec
Secondary outcomes:
measure: Diagnostic Method That Detects Gastric Insufflation First
timeFrame: Interval between start of mask ventilation and detection of gastric insufflation, an expected average of 100 sec
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University
name: Jin-Tae Kim, MD. PhD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee JH, Jung H, Kim EH, Song IK, Kim HS, Kim JT. Optimal inspiratory pressure for face mask ventilation in paralyzed and unparalyzed children to prevent gastric insufflation: a prospective, randomized, non-blinded study. Can J Anaesth. 2018 Dec;65(12):1288-1295. doi: 10.1007/s12630-018-1183-2. Epub 2018 Jul 11.