NCT02259569

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2014

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 22, 2014

Completed
9 days until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 8, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

April 24, 2015

Status Verified

April 1, 2015

Enrollment Period

4 months

First QC Date

September 22, 2014

Last Update Submit

April 23, 2015

Conditions

Pediatric Urologic Surgeries

Keywords

Gastric insufflationI-gelPeak airway pressurePressure-controlled ventilationVolume-Controlled Ventilationpediatric patient

Outcome Measures

Primary Outcomes (1)

  • Gastric insufflation determined by increase of cross sectional area of gastric antrum, measured by ultrasonography.

    1 min after I-gel insertion

Secondary Outcomes (3)

  • oropharyngeal leak pressure

    1 min after caudal block

  • FOB grade

    1 min after I-gel insertion

  • peak airway pressure

    1 min after I-gel insertion

Other Outcomes (2)

  • dynamic compliance

    1 min after end of surgery

  • typical gurgle or whoosh sound

    1 min after caudal block

Study Arms (2)

PCV group

EXPERIMENTAL

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

VCV group

ACTIVE COMPARATOR

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

Interventions

Pressure-controlled ventilationOTHER
PCV group
Volume-controlled ventilationOTHER
VCV group

Eligibility Criteria

Age6 Months - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2014

First Posted

October 8, 2014

Study Start

October 1, 2014

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

April 24, 2015

Record last verified: 2015-04