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OpenTrials
Completed

NCT Number: NCT03294226

Comparison of AuraGain With I-gel for Pediatric Patients

Children from 6 months to 6 years are randomly allocated into AuraGain group or I-gel group. After anesthetic induction without neuromuscular blocking agent, assigned device in inserted by skillful anesthesiologist. The outcome measures are recorded and analysed.

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Key information

Conditions

General Anesthesia

Age range

6 month–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Asan Medical Center

Seoul, 05505, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • ASA physical status: 1-3
  • age: from 6 months to 6 year
  • body weight: 5-20kg
  • patients undergoing upper/lower extremity surgery at supine position

Exclusion criteria

  • patients who do not want to participate in this study
  • patients with known difficult airway including congenital facial anomaly or history of difficult airway management
  • patients with aspiration risk (gastrointestinal stenosis or stricture)
  • patients with symptom of upper respiratory infection on the day of surgery
  • patients scheduled for day surgery
  • patients judged as not eligible by researchers for other reasons

Treatment and study plan

AuraGain

Device

After anesthetic induction without neuromuscular blocking agent, AuraGain is inserted.

I-gel

Device

After anesthetic induction without neuromuscular blocking agent, I-gel is inserted.

Primary outcomes

  1. requirement of additional airway maneuver

    Time frame: during placement/maintenance of the device

    including adjustment of head/neck position or insertion depth and taping of the device

Secondary outcomes

  1. insertion time

    Time frame: during placement of the device

  2. success rate

    Time frame: during placement of the device

  3. ease of gastric tube insertion

    Time frame: within 10 minutes after device insertion

  4. adverse effect at operating room

    Time frame: during anesthesia

    aspiration of gastric fluid, hypoxia, SpO2<90%, bronchospasm, dental/tongue/lip trauma, staining of blood on the removed device

  5. postoperative adverse effect

    Time frame: within postoperative 24 hours

    sore throat, hoarseness, airway obstruction

  6. fiberoptic view of glottis

    Time frame: within 10 minutes after device insertion

    Brimacombe score

  7. oropharyngeal leak pressure

    Time frame: at 1 minute after device insertion, at 10 minutes after device insertion

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Registry information

Official study title

A Randomized Trial of Ambu® AuraGain™ Versus I-gel® in Young Children

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 26, 2017
Registry last updated
May 11, 2018

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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