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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-12

Study Completion Date

2016-06-01

Brief Summary

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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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Detailed Description

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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.

Conditions

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Exposure to Environmental Pollution Adverse Effect of Unspecified General Anesthetic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Uncuffed tracheal tubes

After tracheal intubation with an uncuffed tube, the interventions will be the oxygen concentration, nitrous oxide concentration, carbon dioxide concentration and sevoflurane concentration measured in the tracheal tube compared with those in the oropharynx during spontaneous and controlled ventilation.

Group Type PLACEBO_COMPARATOR

oxygen concentration

Intervention Type DRUG

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

nitrous oxide concentration

Intervention Type DRUG

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

carbon dioxide concentration

Intervention Type DRUG

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

sevoflurane concentration

Intervention Type DRUG

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

Cuffed tracheal tubes

After tracheal intubation with a cuffed tube, the interventions will be the oxygen concentration, nitrous oxide concentration, carbon dioxide concentration and sevoflurane concentration measured in the tracheal tube compared with those in the oropharynx during spontaneous and controlled ventilation.

Group Type ACTIVE_COMPARATOR

oxygen concentration

Intervention Type DRUG

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

nitrous oxide concentration

Intervention Type DRUG

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

carbon dioxide concentration

Intervention Type DRUG

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

sevoflurane concentration

Intervention Type DRUG

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

Interventions

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oxygen concentration

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

Intervention Type DRUG

nitrous oxide concentration

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

Intervention Type DRUG

carbon dioxide concentration

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

Intervention Type DRUG

sevoflurane concentration

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

Intervention Type DRUG

Other Intervention Names

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difference in the oxygen concentration difference in the nitrous oxide concentration difference in the carbon dioxide concentration difference in the sevoflurane concentration

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. refusal of consent by parents
2. difficult tracheal intubation
3. craniofacial anomalies
4. gastroesophageal reflux
5. malignant hyperthermia
6. randomization to a tracheal tube is unacceptable.

Minimum Eligible Age

1 Year

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No