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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02725164
Enrollment
31
Registered
2016-03-31
Start date
2016-04-12
Completion date
2016-06-01
Last updated
2017-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adverse Effect of Unspecified General Anesthetic, Exposure to Environmental Pollution

Keywords

oxygen, nitrous oxide, sevoflurane, carbon dioxide, endotracheal tube, respiration

Brief summary

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.

Detailed description

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.

Interventions

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

DRUGnitrous oxide concentration

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

DRUGcarbon dioxide concentration

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

DRUGsevoflurane concentration

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

Sponsors

State University of New York at Buffalo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Years to 6 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Difference in the oxygen concentration with uncuffed and cuffed tubes during spontaneous or controlled ventilation8 monthsThe differences in the oxygen concentration measured in the trachea and the oropharynx with uncuffed and cuffed tubes during spontaneous or controlled ventilation

Secondary

MeasureTime frameDescription
Difference in the nitrous oxide concentration with uncuffed and cuffed tubes during spontaneous or controlled ventilation8 monthsThe differences in the nitrous oxide concentration measured in the trachea and the oropharynx with uncuffed and cuffed tubes during spontaneous or controlled ventilation
Difference in the carbon dioxide concentration with uncuffed and cuffed tubes during spontaneous or controlled ventilation8 monthsThe differences in the carbon dioxide concentration measured in the trachea and the oropharynx with uncuffed and cuffed tubes during spontaneous or controlled ventilation
Difference in the sevoflurane concentration with uncuffed and cuffed tubes during spontaneous or controlled ventilation8 monthsThe differences in the sevoflurane concentration measured in the trachea and the oropharynx with uncuffed and cuffed tubes during spontaneous or controlled ventilation

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026