An observational study in Anesthesia Intubation Complication and Mechanical Ventilation Complication, sponsored by University of Mississippi Medical Center. Completed at 1 site in United States. Open to participants aged 1 Month to 8 Years. Per ClinicalTrials.gov, last updated 2017-07-02.
Sponsored by University of Mississippi Medical Center · Observational
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.
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.
University of Mississippi Medical Center is the lead sponsor of 125 studies on the registry; 19 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 4 (57%) have results posted.
Counted across the registry records on this site, refreshed daily.
Children aged between 1 month (post-natal) and 8 years scheduled for ENT surgery requiring general anesthesia with an endotracheal tube.
Exclusion Criteria:
Assess for Audible Endotracheal Leak; Assess for Endotracheal Leak with direct visualization under rigid bronchoscope
Other: Assess for Audible Endotracheal Leak · Other: Assess for Endotracheal Leak with direct visualization under rigid bronchoscope
In supine position, the head will be positioned in neutral position. With fresh gas flow at 2-5L/min, and pop off valve in the anesthesia machine closed and pressure in the inspiratory circuit is slowly increased until an audible leak is heard at the mouth. That pressure will be recorded.
In the same patient position, a flexible nasal laryngoscope will be inserted and positioned superior to the laryngeal inlet by the surgeon. With fresh gas flow at 2-5L/min, and pop off valve in the anesthesia machine closed, the pressure in the inspiratory circuit will be increased slowly until a leak around the TT will be visualized by inspecting the supraglottic area for bubbles or air movement around the TT. The peak pressure at which leak is observed physically will be recorded. This is the end of the study.
Primary Objective Evidence of an audible endotracheal leak and/or direct visualized endotracheal leak
Evidence of an audible endotracheal leak and/or direct visualized endotracheal leak using a flexible nasal laryngoscope positioned superior to the laryngeal inlet.
Time frame: one year.
Secondary Objective Evidence suggesting a relationship between the presence of an audible leak and direct visualization for cuffed and uncuffed TT's
Evidence suggesting a relationship between the presence of an audible leak and direct visualization for cuffed and uncuffed TT's.
Time frame: one year.
This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.
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University of Mississippi Medical Center