Laryngoscope Force During Suspension for Adenotonsillectomy

Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre (Other)
Overall Status
Recruiting
CT.gov ID
NCT06115798
Collaborator
(none)
100
1
17.1
5.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Laryngoscope Force During Suspension for Adenotonsillectomy
    Actual Study Start Date :
    Mar 1, 2023
    Anticipated Primary Completion Date :
    Mar 1, 2024
    Anticipated Study Completion Date :
    Aug 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Force Metrics [Measured continuously during the procedure]

      Laryngoscopy suspension force

    2. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Month to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 McGill University Health Centre Montréal Quebec Canada H4A 3J1

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: Gianluca Bertolizio, MD, McGill University Health Centre/Research Institute of the McGill University Health Centre

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Gianluca Bertolizio, Principle Investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
    ClinicalTrials.gov Identifier:
    NCT06115798
    Other Study ID Numbers:
    • 2023-9146
    First Posted:
    Nov 3, 2023
    Last Update Posted:
    Nov 3, 2023
    Last Verified:
    Oct 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 3, 2023