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UnknownNCT06115798

Laryngoscope Force During Suspension for Adenotonsillectomy

Status
Unknown
Phase
Study type
Observational
Enrollment
100 (estimated)
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre · Academic / Other
Sex
All
Age
1 Month – 18 Years
Healthy volunteers
Accepted

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

Timeline

Start date
2023-03-01
Primary completion
2024-03-01
Completion
2024-08-01
First posted
2023-11-03
Last updated
2023-11-03

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT06115798. Inclusion in this directory is not an endorsement.