Obstructive Sleep Apnea Clinical Trial
Official title:
Prospective, Controlled Clinical Trial of a Novel Hemostatic Sealant Versus Electrocautery Hemostasis and Coblation Dissection in Patients Undergoing Tonsillectomy
The purpose of this study is to evaluate a new method of hemostasis, floseal gel, in tonsillectomy and adenoidectomy, with the goal of decreasing post operative and intraoperative morbidity.
Blood loss and postoperative morbidity following adenotonsillectomy in children can be
significant. The current technique for performing a tonsillectomy is "cold steel
tonsillectomy" with electocautery hemostasis and a newer technique of coblation
tonsillectomy. Postoperative pain has been shown to be increased in patients undergoing
extensive electrocautery, with less pain seen in patients undergoing coblation
tonsillectomy. The purpose of the study is to evaluate the clinical efficacy and
complications of Floseal matrix hemostatic sealant for use in patients undergoing
adenotonsillectomy compared with two other currently used techniques.
The study is a prospective, controlled clinical trial comparing Floseal hemostasis in "cold
steel" knife dissection tonsillectomy with cautery hemostasis in "cold steel" knife
dissection tonsillectomy and coblation tonsillectomy in a pediatric population. All children
under the age of 18 without previous documented coagulopathy scheduled to undergo
tonsillectomy will be offered enrollment in the study. Informed consent will be obtained
from the patient's legal guardian. The goal of this study is to determine if Floseal reduces
intraoperative blood loss, time to hemostasis, and postoperative morbidity in patients
undergoing tonsillectomy compared with two other commonly used methods. Also, we wish to
evaluate the complication rates following Floseal administration compared to those of
electrocautery and coblation.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05857384 -
Bioavailability, Bioequivalence and Tolerability of IHL-42X Compared to the Reference Drugs
|
Phase 1 | |
| Recruiting |
NCT04547543 -
Follow-up of Apneic Patients by Visio-consultation
|
N/A | |
| Recruiting |
NCT05371509 -
Novel Myofunctional Water Bottle to Reduce OSA and Snoring Study
|
N/A | |
| Completed |
NCT02515357 -
Mediterranean Diet/Lifestyle Intervention in Obstructive Sleep Apnea
|
N/A | |
| Completed |
NCT05582070 -
Effect on Sleep of Surgical Treatment of Severe Nasal Obstruction
|
N/A | |
| Active, not recruiting |
NCT03189173 -
Combined Upper-airway and Breathing Control Therapies for Obstructive Sleep Apnea
|
Phase 2 | |
| Completed |
NCT04084899 -
The Effect of CPAP on Lung Hyperinflation in Patients With OSA
|
||
| Completed |
NCT03032029 -
Registry on the Treatment of Central and Complex Sleep-Disordered Breathing With Adaptive Servo-Ventilation
|
||
| Recruiting |
NCT04028011 -
Clinical Evaluation of a Wearable Technology for the Diagnosis of Sleep Apnoea
|
||
| Recruiting |
NCT06047353 -
Community Health Advocates for Motivating PAP Use in Our Neighborhoods.
|
N/A | |
| Completed |
NCT05253963 -
Acute Effect of CPAP on Weight in Patients With Obstructive Sleep Apnea
|
N/A | |
| Recruiting |
NCT06029959 -
Stroke and CPAP Outcome Study 3
|
N/A | |
| Recruiting |
NCT06150352 -
Sleep Apnea, Neurocognitive Decline and Brain Imaging in Patients With Subjective or Mild Cognitive Impairment
|
||
| Completed |
NCT03589417 -
Postural Stability, Balance and Fall Risk in Patients With Obstructive Sleep Apnea
|
||
| Recruiting |
NCT04335994 -
ENhancing Outcomes in Cognitive Impairment Through Use of Home Sleep ApNea Testing
|
N/A | |
| Withdrawn |
NCT04063436 -
Evaluation of a New Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea
|
N/A | |
| Recruiting |
NCT05385302 -
Sociological Determinants of Positive Airway Pressure Adherence in OSA Patients
|
||
| Recruiting |
NCT04572269 -
Metabolomics of Obstructive Sleep Apnea
|
||
| Not yet recruiting |
NCT06467682 -
12-week Tele-exercise Program in Patients With OSA
|
N/A | |
| Withdrawn |
NCT04011358 -
Retinal Vein Occlusion and Obstructive Sleep Apnea: A Case Control Study
|
N/A |