NCT06115798

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 16, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

November 3, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

November 3, 2023

Status Verified

October 1, 2023

Enrollment Period

1 year

First QC Date

October 16, 2023

Last Update Submit

October 31, 2023

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (2)

  • Force Metrics

    Laryngoscopy suspension force

    Measured continuously during the procedure

  • 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

Eligibility Criteria

Age1 Month - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Children

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McGill University Health Centre

Montreal, Quebec, H4A 3J1, Canada

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Gianluca Bertolizio, MD

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gianluca Bertolizio, MD

CONTACT

514586-2674gianluca.bertolizo@mcgill.ca

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

October 16, 2023

First Posted

November 3, 2023

Study Start

March 1, 2023

Primary Completion

March 1, 2024

Study Completion

August 1, 2024

Last Updated

November 3, 2023

Record last verified: 2023-10

Locations

CA(1)