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Laryngoscope Force During Suspension for Adenotonsillectomy

Laryngoscope Force During Suspension for Adenotonsillectomy

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06115798
Enrollment
100
Registered
2023-11-03
Start date
2023-03-01
Completion date
2024-08-01
Last updated
2023-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain

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.

Interventions

None listed

Sponsors

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

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Months to 18 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Force MetricsMeasured continuously during the procedureLaryngoscopy suspension force
Post-operative negative behaviors (pain, emergence delirium and hypoactive delirium)1 hour after the produceLaryngoscopy suspension force as a tool to predict post-operative negative behaviors

Countries

Canada

Contacts

Primary ContactGianluca Bertolizio, MD
gianluca.bertolizo@mcgill.ca514586-2674

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026