Laryngoscope Force During Suspension for Adenotonsillectomy

Recruiting

• Conditions: Postoperative Pain

• Registration Number: NCT06115798
• Lead Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

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.

Study Timeline

• Study Start: 2023-03-01
• Status Verified: 2023-10
• Study First Submitted: 2023-10-16
• Study First Submitted QC: 2023-10-31
• Last Update Submitted: 2023-10-31
• Study First Posted: 2023-11-03
• Last Update Posted: 2023-11-03
• Primary Completion: 2024-03-01
• Study Completion: 2024-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Force Metrics	Measured continuously during the procedure	Laryngoscopy suspension force
Post-operative negative behaviors (pain, emergence delirium and hypoactive delirium)	1 hour after the produce	Laryngoscopy suspension force as a tool to predict post-operative negative behaviors

Trial Locations

Locations (1)

McGill University Health Centre; 🇨🇦 Montréal, Quebec, Canada