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OpenTrials
Completed

NCT Number: NCT02259569

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

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Key information

Conditions

Pediatric Urologic Surgeries

Age range

6 month–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pressure-controlled ventilation

Other

Volume-controlled ventilation

Other

Primary outcomes

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

    Time frame: 1 min after I-gel insertion

Secondary outcomes

  1. oropharyngeal leak pressure

    Time frame: 1 min after caudal block

  2. FOB grade

    Time frame: 1 min after I-gel insertion

    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

  3. peak airway pressure

    Time frame: 1 min after I-gel insertion

Other outcomes

  1. dynamic compliance

    Time frame: 1 min after end of surgery

  2. typical gurgle or whoosh sound

    Time frame: 1 min after caudal block

    gastric insufflation determined by continuous epigastric auscultation

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Oct 8, 2014
Registry last updated
Apr 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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