Laryngoscope Force During Suspension for Adenotonsillectomy

NCT ID: NCT06115798

Last Updated: 2023-11-03

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2024-08-01

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.

Conditions

Postoperative Pain

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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.

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

McGill University Health Centre/Research Institute of the McGill University Health Centre

OTHER

Sponsor Role: lead

Responsible Party

Gianluca Bertolizio

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gianluca Bertolizio, MD

Role: PRINCIPAL_INVESTIGATOR

McGill University Health Centre/Research Institute of the McGill University Health Centre

Locations

McGill University Health Centre

Montreal, Quebec, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Gianluca Bertolizio, MD

Role: CONTACT

gianluca.bertolizo@mcgill.ca

514586-2674

Facility Contacts

Gianluca Bertolizio, MD

Role: primary

gianluca.bertolizo@mcgill.ca

514586-2674

Other Identifiers

2023-9146

Identifier Type: -

Identifier Source: org_study_id