Clinical trial NCT02725164: Anesthetic Gas Leakage in Children During Tonsillectomy: a Comparison of Cuffed and Uncuffed Tracheal Tubes
Official title: Anesthetic Gas Leakage in Children During Tonsillectomy: a Comparison of Cuffed and Uncuffed Tracheal Tubes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exposure to Environmental Pollution
Adverse Effect of Unspecified General Anesthetic
Keywords: oxygen
nitrous oxide
sevoflurane
carbon dioxide
endotracheal tube
respiration
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
First posted: 2016-03-31
Enrollment: 31
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Difference in the oxygen concentration with uncuffed and cuffed tubes during spontaneous or controlled ventilation
timeFrame: 8 months
Secondary outcomes:
measure: Difference in the nitrous oxide concentration with uncuffed and cuffed tubes during spontaneous or controlled ventilation
timeFrame: 8 months
measure: Difference in the carbon dioxide concentration with uncuffed and cuffed tubes during spontaneous or controlled ventilation
timeFrame: 8 months
measure: Difference in the sevoflurane concentration with uncuffed and cuffed tubes during spontaneous or controlled ventilation
timeFrame: 8 months
Other outcomes:
Locations:
Study officials:
affiliation: Women & Children's Hospital of Buffalo
name: Jerrold Lerman, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1093/bja/aeh023.
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. doi: 10.1097/00000542-199703000-00015.
citation: 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. Epub 2010 Jun 15.
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.
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. Epub 2012 Mar 23.