Clinical trial NCT02461017: Endotracheal Tube Audible Leak Test
Official title: Endotracheal Tube Audible Leak Test: What is the Accuracy?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia Intubation Complication
Mechanical Ventilation Complication
Keywords: intubation
ventilation
airway
airleak
Lead sponsor: University of Mississippi Medical Center
Sponsor class: OTHER
First posted: 2015-06-03
Enrollment: 86
Sex: ALL
Minimum age (years): 1
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children aged between 1 month (post-natal) and 8 years scheduled for ENT surgery requiring general anesthesia with an endotracheal tube.

Brief summary: The endotracheal tube (ETT) leak test (LT), or audible leak test is a widely performed assessment to verify appropriate tube size in neonates, infants and children. However, many factors are known to influence the audible leak test. Even though the test is widely performed, the accuracy has not been evaluated.

Detailed description: The endotracheal tube (ETT) leak test (LT), or audible leak when the peak airway pressures reach 15-30 cmH2O, is a commonly performed assessment to confirm that an endotracheal tube size is appropriate for a child in order to minimize the risk of airway injury and adverse events after removal of ETT. Many factors are known to affect the results of the leak test and variation in results among experienced anesthesiologists may be as great as 38%, but the accuracy of the audible leak test by directly observing the presence of a leak around the ETT has not been evaluated. This study will attempt to use direct visualization of the air leak to correlate to and assess the accuracy of the audible air leak test.

Eligibility criteria: Inclusion Criteria:

* Children aged between 1 month (post-natal) and 8 years scheduled for ENT surgery requiring general anesthesia with an endotracheal tube.

Exclusion Criteria:

* Known history of subglottic stenosis
* Known history of recurrent croup
* Known history of endolaryngeal or subglottic lesions
* Parents refusal of participation in study

Primary outcomes:
measure: Primary Objective Evidence of an audible endotracheal leak and/or direct visualized endotracheal leak
timeFrame: one year.
Secondary outcomes:
measure: Secondary Objective Evidence suggesting a relationship between the presence of an audible leak and direct visualization for cuffed and uncuffed TT's
timeFrame: one year.
Other outcomes:
Locations:
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
Study officials:
affiliation: Univeristy of Mississippi Medical Center
name: Madhankumar Sathyamoorthy, MBBS, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Suominen P, Taivainen T, Tuominen N, Voipio V, Wirtavuori K, Hiller A, Korpela R, Karjalainen T, Meretoja O. Optimally fitted tracheal tubes decrease the probability of postextubation adverse events in children undergoing general anesthesia. Paediatr Anaesth. 2006 Jun;16(6):641-7. doi: 10.1111/j.1460-9592.2005.01832.x.
citation: Finholt DA, Henry DB, Raphaely RC. Factors affecting leak around tracheal tubes in children. Can Anaesth Soc J. 1985 Jul;32(4):326-9. doi: 10.1007/BF03011335.
citation: Schwartz RE, Stayer SA, Pasquariello CA. Tracheal tube leak test--is there inter-observer agreement? Can J Anaesth. 1993 Nov;40(11):1049-52. doi: 10.1007/BF03009476.