Comparison of Peak Airway Pressure and Gastric Insufflation in Pressure-Controlled Ventilation or Volume-Controlled Ventilation With I-Gel in Pediatric Patient

The purpose of this study is to compare peak airway pressure and gastric insufflation in Pressure-Controlled Ventilation or Volume-Controlled Ventilation with I-Gel in pediatric patient

Study Overview

• Status: Completed
• Conditions: Pediatric Urologic Surgeries
• Intervention / Treatment: Other: Pressure-controlled ventilation; Other: Volume-controlled ventilation

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 7 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

① ASA I-II patients aged between 1 and 7 year undergoing elective urologic surgery.

Exclusion Criteria:

• parent refusal

  • clinically significant respiratory disease ③ congenital airway abnormalities, oropharyngeal or facial pathology ④ risk of aspiration

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PCV group; After insertion of I-gel, mechanical ventilation of the lungs was commenced. Mechanical ventilator was set to obtain a tidal volume of 8ml/kg in pressure-controlled mode.	Other: Pressure-controlled ventilation
Active Comparator: VCV group; After insertion of I-gel, mechanical ventilation of the lungs was commenced. Mechanical ventilator was set to obtain a tidal volume of 8ml/kg in volume-controlled mode.	Other: Volume-controlled ventilation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Gastric insufflation determined by increase of cross sectional area of gastric antrum, measured by ultrasonography.	1 min after I-gel insertion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
oropharyngeal leak pressure		1 min after caudal block
FOB grade	grade 1= only the vocal cords visible, 2= vocal cords and epiglottis visible, 3= only the epiglottis visible, 4= vocal cords and epiglottis not visible	1 min after I-gel insertion
peak airway pressure		1 min after I-gel insertion

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
dynamic compliance		1 min after end of surgery
typical gurgle or whoosh sound	gastric insufflation determined by continuous epigastric auscultation	1 min after caudal block

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: September 22, 2014
• First Submitted That Met QC Criteria: October 5, 2014
• First Posted (Estimate): October 8, 2014

Study Record Updates

• Last Update Posted (Estimate): April 24, 2015
• Last Update Submitted That Met QC Criteria: April 23, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: I-gel; pediatric patient; Peak airway pressure; Gastric insufflation; Pressure-controlled ventilation; Volume-Controlled Ventilation
• Other Study ID Numbers: 4-2014-0594