Anesthetic Gas Leakage in Children During Tonsillectomy: a Comparison of Cuffed and Uncuffed Tracheal Tubes
1 other identifier
interventional
31
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2016
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 25, 2016
CompletedFirst Posted
Study publicly available on registry
March 31, 2016
CompletedStudy Start
First participant enrolled
April 12, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedFebruary 13, 2017
February 1, 2017
2 months
March 25, 2016
February 10, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Difference in the nitrous oxide concentration with uncuffed and cuffed tubes during spontaneous or controlled ventilation
8 months
Difference in the carbon dioxide concentration with uncuffed and cuffed tubes during spontaneous or controlled ventilation
8 months
Difference in the sevoflurane concentration with uncuffed and cuffed tubes during spontaneous or controlled ventilation
8 months
Study Arms (2)
Uncuffed tracheal tubes
PLACEBO COMPARATORAfter 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.
Cuffed tracheal tubes
ACTIVE COMPARATORAfter 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.
Interventions
oxygen concentration will be measured in the tracheal tube and oropharynx during spontaneous or controlled ventilation
nitrous oxide concentration will be measured in the tracheal tube and oropharynx during spontaneous or controlled ventilation
carbon dioxide concentration will be measured from the tracheal tube and in the oropharynx during spontaneous or controlled ventilation
sevoflurane concentration will be measured in the tracheal tube and oropharynx during spontaneous or controlled ventilation
Eligibility Criteria
You may qualify if:
- American society of anesthesiologists physical status 1 and 2;
- fasted
- scheduled for elective adenotonsillectomy
You may not qualify if:
- refusal of consent by parents
- difficult tracheal intubation
- craniofacial anomalies
- gastroesophageal reflux
- malignant hyperthermia
- randomization to a tracheal tube is unacceptable.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (5)
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.
PMID: 14665558BACKGROUNDKhine 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.
PMID: 9066329BACKGROUNDEschertzhuber 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.
PMID: 20560884BACKGROUNDMehta 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.
PMID: 23422795BACKGROUNDRaman 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.
PMID: 22444738BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jerrold Lerman, MD, FRCPC
Women & Children's Hospital of Buffalo
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Professor of Anesthesia
Study Record Dates
First Submitted
March 25, 2016
First Posted
March 31, 2016
Study Start
April 12, 2016
Primary Completion
June 1, 2016
Study Completion
June 1, 2016
Last Updated
February 13, 2017
Record last verified: 2017-02
Data Sharing
- IPD Sharing
- Will not share