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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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date August 1, 2024
Est. primary completion date March 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 1 Month to 18 Years
Eligibility 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


Related Conditions & MeSH terms


Locations

Country Name City State
Canada McGill University Health Centre Montréal Quebec

Sponsors (1)

Lead Sponsor Collaborator
McGill University Health Centre/Research Institute of the McGill University Health Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Force Metrics Laryngoscopy suspension force Measured continuously during the procedure
Primary Post-operative negative behaviors (pain, emergence delirium and hypoactive delirium) Laryngoscopy suspension force as a tool to predict post-operative negative behaviors 1 hour after the produce
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