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Subglottic stenosis is a common sequelae of prolonged endotracheal intubation. Radial expansion balloon dilation has become commonplace for stenosis management. This allows for increased dilation diameters with minimal tangential shearing forces that could damage normal respiratory mucosa. These dilation procedures require intermittent complete luminal obstruction. Balloon dilator malfunctions have lead to prolonged obstruction, resulting in serious patient complications, including death. Given the therapeutic value of these devices, it is imperative to recognize the potential risks and develop an effective response to device malfunction. The objective of this study was to determine the physical parameters required to rupture balloon devices and to develop a protocol to efficiently re-establish a patent airway. A model of subglottic stenosis was designed to determine deflation time required to withdraw a balloon (Figure 1). Dilation balloons (15-16.5-18 mm Hercules 3 stage, Cook Medical) were inflated to predetermined pressure and 20N axial tension pulled against balloon to simulate force applied by surgeon. Balloons were punctured with 23G needle through a flexible endoscope. Deflation time, defined as the time required for fluid egress until tension force decreased from 20N to 10N, and number of puncture attempts were recorded. Decreased tension allowed for balloon removal. E. Brandon Strong, Daniel J. Cates, Derrick R. Randall, Peter C. Belafsky University of California at Davis Department of Otolaryngology-Head and Neck Surgery Center for Voice and Swallowing 2521 Stockton Boulevard, Suite 7200, Sacramento, CA 95817 USA Increasing the inflation pressure of a malfunctioning dilator and placing the patient in a horizontal position may promote safe balloon removal. Spontaneous rupture occurred at 12 atm inflation, and consistent rupture with needle puncture occurred at 8 atm inflation. Partially decompressed balloons can take between 0 and 87.5 seconds to deflate, which may be much longer than many practitioners would expect. In the rare event that a malfunction does occur, having an established protocol may reduce the chances of a serious complication. Figure 3. Flowchart of Proposed Emergency Protocol. E. Brandon Strong University of California, Davis [email protected] Figure 2. Mean Number of Puncture Attempts to breach balloon integrity (n=23). Inflation Pressure, atm (n) Median Deflation Time, seconds (Range) 2 (n=7) 30.2 (7.1-87.5) 4 (n=8) 21.75 (8.6-79.4) 6 (n=8) 17.5 (0-55.3) 8 (n=4) 0 12 (n=4)* 0 Figure 1. Model of Subglottic Stenosis. A) Diagram B) Photograph Table 1. Median Deflation Times after Needle Puncture. *spontaneous rupture without puncture

E. Brandon Strong, Daniel J. Cates, Derrick R. Randall ... · Derrick R. Randall, Peter C. Belafsky University of California at Davis Department of Otolaryngology-Head and Neck Surgery

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Page 1: E. Brandon Strong, Daniel J. Cates, Derrick R. Randall ... · Derrick R. Randall, Peter C. Belafsky University of California at Davis Department of Otolaryngology-Head and Neck Surgery

Subglottic stenosis is a common

sequelae of prolonged endotracheal

intubation. Radial expansion balloon

dilation has become commonplace for

stenosis management. This allows for

increased dilation diameters with minimal

tangential shearing forces that could

damage normal respiratory mucosa.

These dilation procedures require

intermittent complete luminal obstruction.

Balloon dilator malfunctions have lead to

prolonged obstruction, resulting in serious

patient complications, including death.

Given the therapeutic value of these

devices, it is imperative to recognize the

potential risks and develop an effective

response to device malfunction. The

objective of this study was to determine

the physical parameters required to

rupture balloon devices and to develop a

protocol to efficiently re-establish a patent

airway.

A model of subglottic stenosis was

designed to determine deflation time

required to withdraw a balloon (Figure 1).

Dilation balloons (15-16.5-18 mm

Hercules 3 stage, Cook Medical) were

inflated to predetermined pressure and

20N axial tension pulled against balloon

to simulate force applied by surgeon.

Balloons were punctured with 23G needle

through a flexible endoscope. Deflation

time, defined as the time required for fluid

egress until tension force decreased from

20N to 10N, and number of puncture

attempts were recorded. Decreased

tension allowed for balloon removal.

E. Brandon Strong, Daniel J. Cates,

Derrick R. Randall, Peter C. Belafsky

University of California at Davis

Department of Otolaryngology-Head and Neck Surgery

Center for Voice and Swallowing

2521 Stockton Boulevard, Suite 7200, Sacramento, CA 95817 USA

Increasing the inflation pressure of a malfunctioning dilator and

placing the patient in a horizontal position may promote safe

balloon removal. Spontaneous rupture occurred at 12 atm

inflation, and consistent rupture with needle puncture occurred

at 8 atm inflation. Partially decompressed balloons can take

between 0 and 87.5 seconds to deflate, which may be much

longer than many practitioners would expect. In the rare event

that a malfunction does occur, having an established protocol

may reduce the chances of a serious complication.

Figure 3. Flowchart of Proposed Emergency Protocol.

E. Brandon Strong

University of California, Davis

[email protected]

Figure 2. Mean Number of Puncture Attempts to breach balloon

integrity (n=23).

Inflation Pressure, atm (n)

Median Deflation Time, seconds (Range)

2 (n=7) 30.2 (7.1-87.5)

4 (n=8) 21.75 (8.6-79.4)

6 (n=8) 17.5 (0-55.3)

8 (n=4) 0

12 (n=4)* 0

Figure 1. Model of Subglottic Stenosis. A) Diagram B) Photograph

Table 1. Median Deflation Times after Needle

Puncture.

*spontaneous rupture without puncture