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Completed

NCT Number: NCT02224196

Comparison of Peak Airway Pressure and Gastric Insufflation in Manual Ventilation and Pressure-controlled Ventilation With Facemask During Anesthesia Induction in Children

Comparison of peak airway pressure and gastric insufflation in manual ventilation and pressure-controlled ventilation with facemask during anesthesia induction in children.

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Key information

Conditions

Elective Urologic Surgeries

Age range

6 month–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesiology & Pain Medicine, Yonsei university college of medicine

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • ASA physical status with I or II
  • Those parents who signed with informed consents.
  • Children who are scheduled for elective urologic surgery (aged 6 month to 7 year)

Exclusion criteria

  • Risk of aspiration
  • Oropharyngeal or facial anomaly
  • history of abdominal (stomach) surgery

Treatment and study plan

manual ventilation

Other

Anesthesia will be induced by propofol 1mg/kg via intravenous line. Once loss of eyelash reflex occurred, ultrasonography of antral area will be started by same physician. After administration of muscle relaxant (rocuronium 0.2-0.4mg/kg), manual ventilation will be performed with respiratory rate 20 breathes/min, I:E ratio of 1:1 and tidal volume with 9-10mL/kg. The pop-off valve will be set at 15cmH2O at fixed gas flow of 500mL/min of oxygen. Pressure-controlled ventilation will be performed with respiratory rate 20 breaths/min, I:E ratio of 1:1 and peak airway pressure will be set to get a tidal volume of 9-10mL/kg. The peak airway pressure during facemask ventilation will be checked. Another physician will auscultate the epigastric area to detect gastric insufflation during facemask ventilation. Ultrasonography of antral area will be checked once again after 3 minutes of facemask ventilation.

Pressure-controlled ventilation

Other

Anesthesia will be induced by propofol 1mg/kg via intravenous line. Once loss of eyelash reflex occurred, ultrasonography of antral area will be started by same physician. After administration of muscle relaxant (rocuronium 0.2-0.4mg/kg), manual ventilation will be performed with respiratory rate 20 breathes/min, I:E ratio of 1:1 and tidal volume with 9-10mL/kg. The pop-off valve will be set at 15cmH2O at fixed gas flow of 500mL/min of oxygen. Pressure-controlled ventilation will be performed with respiratory rate 20 breaths/min, I:E ratio of 1:1 and peak airway pressure will be set to get a tidal volume of 9-10mL/kg. The peak airway pressure during facemask ventilation will be checked. Another physician will auscultate the epigastric area to detect gastric insufflation during facemask ventilation. Ultrasonography of antral area will be checked once again after 3 minutes of facemask ventilation.

Primary outcomes

  1. peak airway pressure

    Time frame: 3 minutes

    The primary outcome is the difference of peak airway pressure produced by manual ventilation group and pressure-controlled ventilation group during induction of anesthesia.

Secondary outcomes

  1. antral area of stomach

    Time frame: 3 minutes

    All patients' antral area of stomach will be calculated by ultrasound after 3 minutes-facemask ventilation to estimate the quantity of gas insufflation.

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Aug 25, 2014
Registry last updated
Jan 25, 2017

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.