Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06115798 |
| Other study ID # |
2023-9146 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2023 |
| Est. completion date |
August 1, 2024 |
Study information
| Verified date |
October 2023 |
| Source |
McGill University Health Centre/Research Institute of the McGill University Health Centre |
| Contact |
Gianluca Bertolizio, MD |
| Phone |
514586-2674 |
| Email |
gianluca.bertolizo[@]mcgill.ca |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Suspension laryngoscopy is a common procedure during adenoteonsillectomy (removal of adenoids
and tonsils), that consists of extending the patient's neck to allow better visualization of
the tonsils. Previous studies on suspension larygnoscopy have shown that the time to maximum
force during this procedure predicts complications such as pain, tounge swelling and opioid
requirements. Moreover, monitoring these force during laparoscopy can reduce postoperative
complications. However, no study to date has investigated the force metrics during suspension
laryngoscopy in the pediatric population. Therefore, in this study, the investigators aim to
evaluate the relationship of force metrics during adenotonsillectomy, adenoidectomy or
tonsillectomy and postoperative pain.
Description:
Adenotonsillectomy is the most common surgery performed in North America (annual caseload in
the United States 500,000). This procedure is performed with suspension laryngoscopy (SL),
which consists in the extension of the patient's neck and concomitant lifting of the anterior
oropharynx structures to allow direct visualization of the tonsils.
In adults undergoing microlaryngoscopy, the time maximum force recorded during suspension was
a significant predictive variable for the development of postoperative complications such as
tongue edema, pain and narcotic requirements. Force metrics during laryngoscopy vary
significantly among different surgical procedures. Active intraoperative monitoring of force
metrics has been shown to reduce postoperative complications in adults. Moreover, in adult
cadaveric models, spinal cord compression associated with cord injury may be directly
correlated with the force applied during laryngoscopy5,6. In patients with cervical
instability, such as patients with Trisomy, adenotonsillectomy carries a significant risk of
spinal injury, as laryngoscopy may result in C1-C2 subluxation.
To date, no data exist on force metric during suspension laryngoscopy children. The primary
aim of this study is to investigate the relationship of force metrics during
adenotonsillectomy, adenoidectomy or tonsillectomy and postoperative pain.
The secondary aim is to describe the force metrics in the pediatric population.
