Clinical trial NCT06115798: Laryngoscope Force During Suspension for Adenotonsillectomy
Official title: Laryngoscope Force During Suspension for Adenotonsillectomy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Postoperative Pain
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2023-11-03
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Children ≤ 18 years old undergoing adenotonsillectomy, adenoidectomy or tonsillectomy
* Only patients whose parents are fluent in French or English will be enrolled

Exclusion Criteria:

* Any contraindication to suspension laryngoscopy
* Patient/legal guardian refusal.

Primary outcomes:
measure: Force Metrics
timeFrame: Measured continuously during the procedure
measure: Post-operative negative behaviors (pain, emergence delirium and hypoactive delirium)
timeFrame: 1 hour after the produce
Secondary outcomes:
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: McGill University Health Centre
state: Quebec
Study officials:
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Gianluca Bertolizio, MD
role: PRINCIPAL_INVESTIGATOR
References: