Sleep Apnea, Obstructive
Conditions
Keywords
tonsillectomy, adenoidectomy, obstructive sleep apnea
Brief summary
Hemostasis will be achieved during Pediatric Tonsillectomy/Adenoidectomy with the use of QuickClot.
Detailed description
The Quickclot dressing contains Kaolin, a natural mineral that promotes the body's clotting process. This dressing will be applied for one minute to the area where the tonsils/adenoids were. The investigators are hoping to develop a standard of practice where Quickclot is a key addition for tonsillectomy surgery.
Interventions
DEVICEQuickClot
1 application of treatment to each tonsil/adenoid removal area
Sponsors
Eastern Virginia Medical School
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Quickclot
Eligibility
Sex/Gender
ALL
Age
2 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* diagnosis of adenotonsillar hypertrophy causing obstructive sleep disorders
Exclusion criteria
* Patients with signs or symptoms of obstructed breathing * recurrent pharyngitis * history of bleeding disorder * history of prior adenotonsillectomy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Suction Electrocautery Time Required for Hemostasis Will be Recorded as Seconds | at the time of surgery, 1 hour | After removal of the adenoids, a tonsil pack wrapped in QuikClot will be placed in the nasopharynx. The investigators will then perform tonsillectomy with the Microdebrider. A QuikClot roll will be placed in the tonsil fossa, and pressure applied via tonsil sponge for one minute. The contralateral tonsil will then be addressed with the same technique. The QuikClot adenoid pack is then removed and residual adenoidal bleeding is addressed with suction electrocautery, followed by placement of a second QuikClot adenoid pack. The tonsil rolls are sequentially removed, followed by control of residual hemostasis with suction electrocautery. A second set of tonsil rolls are placed. After adenoid pack is removed from nasopharynx and bleeding controlled, tonsil rolls are removed, followed by suction electrocautery for any residual hemostasis is performed. |
Countries
United States
Participant flow
Recruitment details
Tertiary children's hospital enrolled 100 consectutive children
Participants by arm
| Arm | Count |
|---|---|
| Quickclot QuickClot sponge will be applied for one minute each site of tonsillectomy and Adenoidectomy | 100 |
| Total | 100 |
Baseline characteristics
| Characteristic | Quickclot |
|---|---|
| Age, Categorical <=18 years | 100 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 4.8 years STANDARD_DEVIATION 3.7 |
| Region of Enrollment United States | 100 participants |
| Sex: Female, Male Female | 48 Participants |
| Sex: Female, Male Male | 52 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 100 |
| serious Total, serious adverse events | 0 / 100 |
Outcome results
Primary
Total Suction Electrocautery Time Required for Hemostasis Will be Recorded as Seconds
After removal of the adenoids, a tonsil pack wrapped in QuikClot will be placed in the nasopharynx. The investigators will then perform tonsillectomy with the Microdebrider. A QuikClot roll will be placed in the tonsil fossa, and pressure applied via tonsil sponge for one minute. The contralateral tonsil will then be addressed with the same technique. The QuikClot adenoid pack is then removed and residual adenoidal bleeding is addressed with suction electrocautery, followed by placement of a second QuikClot adenoid pack. The tonsil rolls are sequentially removed, followed by control of residual hemostasis with suction electrocautery. A second set of tonsil rolls are placed. After adenoid pack is removed from nasopharynx and bleeding controlled, tonsil rolls are removed, followed by suction electrocautery for any residual hemostasis is performed.
Time frame: at the time of surgery, 1 hour
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cauterization Time | Total Suction Electrocautery Time Required for Hemostasis Will be Recorded as Seconds | total cauterization time | 155.3 seconds | Standard Deviation 59.7 |
| Cauterization Time | Total Suction Electrocautery Time Required for Hemostasis Will be Recorded as Seconds | adenoid cauterization time | 60.9 seconds | Standard Deviation 31.5 |
| Cauterization Time | Total Suction Electrocautery Time Required for Hemostasis Will be Recorded as Seconds | tonsil cauterization time | 94.5 seconds | Standard Deviation 41.9 |