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Completed

NCT Number: NCT02725164

Anesthetic Gas Leakage in Children During Tonsillectomy: a Comparison of Cuffed and Uncuffed Tracheal Tubes

Fires and operating room pollution may occur when anesthesia gases leak into the oropharynx during airway surgery. Investigators sought to measure the concentrations of anesthetic gases that leak into the mouth of children undergoing adenotonsillectomy using cuffed and uncuffed tracheal tubes during spontaneous and controlled ventilation.

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Key information

About this study

For the past 6 decades, uncuffed tubes have been used for the children less than 8 years of age out of a fear that cuffed tubes would cause damage to the subglottic region. The correct size uncuffed tube creates a seal in the subglottis that has minimal pressure on the mucosa. However, cuffed tubes have become more widely used in children recently without causing damage to the mucosa. There is very little literature comparing the magnitude of the gas leaks with cuffed and uncuffed tracheal tubes particularly in children. Several authors suggest that the leak of nitrous oxide and sevoflurane with uncuffed tubes was much greater than with cuffed tubes. One important but poorly studied issue is the risk of an airway fire when cautery is used for tonsillectomy because a large leak of oxygen in the mouth could ignite a fire. It also remains unclear whether the mode of ventilation, spontaneous or controlled, affects the leak of gases into the mouth. One might expect that the gas leak with spontaneous ventilation is less than with controlled ventilation, but it may not matter in the context of the small concentrations of oxygen and sevoflurane that investigators use. To address all of these concerns, investigators designed this study to compare the concentrations of gases (oxygen, carbon dioxide, nitrous oxide and sevoflurane) in the oral cavity of children undergoing T&A with either cuffed or uncuffed tubes, during spontaneous and controlled ventilation.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • American society of anesthesiologists physical status 1 and 2;
  • fasted
  • scheduled for elective adenotonsillectomy

Exclusion criteria

  • refusal of consent by parents
  • difficult tracheal intubation
  • craniofacial anomalies
  • gastroesophageal reflux
  • malignant hyperthermia
  • randomization to a tracheal tube is unacceptable.

Treatment and study plan

oxygen concentration

Drug

oxygen concentration will be measured in the tracheal tube and oropharynx during spontaneous or controlled ventilation

Other names: difference in the oxygen concentration

nitrous oxide concentration

Drug

nitrous oxide concentration will be measured in the tracheal tube and oropharynx during spontaneous or controlled ventilation

Other names: difference in the nitrous oxide concentration

carbon dioxide concentration

Drug

carbon dioxide concentration will be measured from the tracheal tube and in the oropharynx during spontaneous or controlled ventilation

Other names: difference in the carbon dioxide concentration

sevoflurane concentration

Drug

sevoflurane concentration will be measured in the tracheal tube and oropharynx during spontaneous or controlled ventilation

Other names: difference in the sevoflurane concentration

Primary outcomes

  1. Difference in the oxygen concentration with uncuffed and cuffed tubes during spontaneous or controlled ventilation

    Time frame: 8 months

    The differences in the oxygen concentration measured in the trachea and the oropharynx with uncuffed and cuffed tubes during spontaneous or controlled ventilation

Secondary outcomes

  1. Difference in the nitrous oxide concentration with uncuffed and cuffed tubes during spontaneous or controlled ventilation

    Time frame: 8 months

    The differences in the nitrous oxide concentration measured in the trachea and the oropharynx with uncuffed and cuffed tubes during spontaneous or controlled ventilation

  2. Difference in the carbon dioxide concentration with uncuffed and cuffed tubes during spontaneous or controlled ventilation

    Time frame: 8 months

    The differences in the carbon dioxide concentration measured in the trachea and the oropharynx with uncuffed and cuffed tubes during spontaneous or controlled ventilation

  3. Difference in the sevoflurane concentration with uncuffed and cuffed tubes during spontaneous or controlled ventilation

    Time frame: 8 months

    The differences in the sevoflurane concentration measured in the trachea and the oropharynx with uncuffed and cuffed tubes during spontaneous or controlled ventilation

Sponsors and collaborators

Lead sponsor

State University of New York at Buffalo

Other

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Mar 31, 2016
Registry last updated
Feb 13, 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.

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