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

Exposure to Environmental Pollution Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02725164
• Other study ID #: Gas leak during tonsillectomy
• Status: Completed
• Phase: N/A
• First received: March 25, 2016
• Last updated: February 10, 2017
• Start date: April 12, 2016
• Est. completion date: June 1, 2016

Study information

• Verified date: February 2017
• Source: State University of New York at Buffalo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: June 1, 2016
• Est. primary completion date: June 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 6 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adverse Effect of Unspecified General Anesthetic
• Exposure to Environmental Pollution

Intervention

Drug:
• oxygen concentration
oxygen concentration will be measured in the tracheal tube and oropharynx during spontaneous or controlled ventilation
• nitrous oxide concentration
nitrous oxide concentration will be measured in the tracheal tube and oropharynx during spontaneous or controlled ventilation
• carbon dioxide concentration
carbon dioxide concentration will be measured from the tracheal tube and in the oropharynx during spontaneous or controlled ventilation
• sevoflurane concentration
sevoflurane concentration will be measured in the tracheal tube and oropharynx during spontaneous or controlled ventilation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
State University of New York at Buffalo

References & Publications (5)

Eschertzhuber S, Salgo B, Schmitz A, Roth W, Frotzler A, Keller CH, Gerber AC, Weiss M. Cuffed endotracheal tubes in children reduce sevoflurane and medical gas consumption and related costs. Acta Anaesthesiol Scand. 2010 Aug;54(7):855-8. doi: 10.1111/j.1399-6576.2010.02261.x. — View Citation

Khine HH, Corddry DH, Kettrick RG, Martin TM, McCloskey JJ, Rose JB, Theroux MC, Zagnoev M. Comparison of cuffed and uncuffed endotracheal tubes in young children during general anesthesia. Anesthesiology. 1997 Mar;86(3):627-31; discussion 27A. — View Citation

Mehta SP, Bhananker SM, Posner KL, Domino KB. Operating room fires: a closed claims analysis. Anesthesiology. 2013 May;118(5):1133-9. doi: 10.1097/ALN.0b013e31828afa7b. — View Citation

Raman V, Tobias JD, Bryant J, Rice J, Jatana K, Merz M, Elmaraghy C, Kang DR. Effect of cuffed and uncuffed endotracheal tubes on the oropharyngeal oxygen and volatile anesthetic agent concentration in children. Int J Pediatr Otorhinolaryngol. 2012 Jun;76(6):842-4. doi: 10.1016/j.ijporl.2012.02.055. — View Citation

Weiss M, Dullenkopf A, Gysin C, Dillier CM, Gerber AC. Shortcomings of cuffed paediatric tracheal tubes. Br J Anaesth. 2004 Jan;92(1):78-88. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in the oxygen concentration with uncuffed and cuffed tubes during spontaneous or controlled ventilation	The differences in the oxygen concentration measured in the trachea and the oropharynx with uncuffed and cuffed tubes during spontaneous or controlled ventilation	8 months
Secondary	Difference in the nitrous oxide concentration with uncuffed and cuffed tubes during spontaneous or controlled ventilation	The differences in the nitrous oxide concentration measured in the trachea and the oropharynx with uncuffed and cuffed tubes during spontaneous or controlled ventilation	8 months
Secondary	Difference in the carbon dioxide concentration with uncuffed and cuffed tubes during spontaneous or controlled ventilation	The differences in the carbon dioxide concentration measured in the trachea and the oropharynx with uncuffed and cuffed tubes during spontaneous or controlled ventilation	8 months
Secondary	Difference in the sevoflurane concentration with uncuffed and cuffed tubes during spontaneous or controlled ventilation	The differences in the sevoflurane concentration measured in the trachea and the oropharynx with uncuffed and cuffed tubes during spontaneous or controlled ventilation	8 months