Randomized Controlled Trial of Balloon Dilation in Treatment of Subglottic Stenosis With a Rabbit Model

Abstract

Objectives Identify the effects of balloon dilation duration and topical ciprofloxacin-dexamethasone application in treatment of subglottic stenosis. Study Design Randomized controlled trial. Setting Animal research facility. Subjects and Methods Forty-four rabbits underwent subglottic injury in an Institutional Animal Care and Use Committee–approved study. One week after injury, the subglottis of each rabbit was measured and treated with endoscopic balloon dilation for 2 rounds of short duration (SBD; 3 seconds), long duration (LBD; 30 seconds), or LBD with topical ciprofloxacin-dexamethasone application (LBD+C). The subglottis of each rabbit was remeasured at the study endpoint: 1 month postdilation or following development of life-threatening respiratory distress. Results Of 44 rabbits, 35 (80%) survived to endoscopic balloon dilation, with 21 rabbits developing a grade III Cotton-Myer stenosis. Prior to dilation, there was no difference in stenosis rates among groups (all subjects, P = .99; grade III stenosis only, P = .52). Among grade III subjects, improvement in stenosis after dilation was –1% (SD, 21%) for SBD, 27% (SD, 38%) for LBD, and 58% (SD, 29%) for LBD+C ( P = .01). Early euthanasia/death rates among grade III subjects were 85% for SBD, 63% for LBD, and 17% for LBD+C ( P = .03). Time to early euthanasia/death was 5.0 days for the SBD group and 8.4 days for the LBD group ( P = .04). Conclusion SBD was inferior to LBD or LBD+C in multiple metrics. LBD+C offered significant improvements in stenosis size and mortality over the SBD group and had the lowest rate of early mortality. Further research is needed to identify optimal balloon dilation treatment duration.

New Treatment Strategy for Subglottic Stenosis Using the Trachealator, a Novel Non‐occlusive Balloon

“…We expect that a better effect will be achieved with long dilatation based on many years of experience with 10‐minute dilatation tracheoscopy using the Groningen Dilatation Tracheoscope (Karl Storz) 2 . Additionally, a recent study in rabbits, showed significantly more effect after long dilatation when compared to short dilatation 4 . In current studies, however, the duration of balloon dilation in humans varies widely and further research is required to confirm the optimal time of dilatation.…”

“…With the conventional balloon dilatation, the airway is blocked, hence only allowing for intermitted dilatation for approximately 30–60 s each time avoiding patient hypoxemia 3 . A recent study in rabbits, showed significantly more effect after long compared to short dilatation 4 …”

Interventional therapy via flexible bronchoscopy in the management of foreign body‐related occlusive endobronchial granulation tissue formation in children

“…Moreover, several studies have reported anecdotal success in reducing or resolving tracheal granulation tissue with adjunctive treatments, such as the utility of local Ciprodex (ciprofloxacin-dexamethasone). [28][29][30] It is hypothesized that the ciprofloxacin acts to decrease bacterial load and associated inflammation, while the dexamethasone acts synergistically with an anti-inflammatory effect at the sight of airway injury. [28][29][30] However, the recommendations on the utility of Ciprodex are based on anecdotal successes, still lack of quantitative data.…”

“…[28][29][30] It is hypothesized that the ciprofloxacin acts to decrease bacterial load and associated inflammation, while the dexamethasone acts synergistically with an anti-inflammatory effect at the sight of airway injury. [28][29][30] However, the recommendations on the utility of Ciprodex are based on anecdotal successes, still lack of quantitative data. Thus, further research is needed to elucidate the application of Ciprodex as an effective adjuvant treatment in a quantitative manner.…”

“…Therefore, it was logical to proceed with and assume the efficacy of cryotherapy to treat obstructive granulation tissue in children. Moreover, several studies have reported anecdotal success in reducing or resolving tracheal granulation tissue with adjunctive treatments, such as the utility of local Ciprodex (ciprofloxacin‐dexamethasone) 28–30 . It is hypothesized that the ciprofloxacin acts to decrease bacterial load and associated inflammation, while the dexamethasone acts synergistically with an anti‐inflammatory effect at the sight of airway injury 28–30 .…”