Risk Stratification of Post Tonsillectomy Respiratory Complications in the Pediatric Population

• Conditions: Post Tonsillectomy Respiratory Complications

• Registration Number: NCT01257321
• Lead Sponsor: Hadassah Medical Organization

Brief Summary

Obstructive sleep apnea syndrome (OSAS) is the most common indication for tonsillectomy and adenoidectomy in young children. According to previous studies, as much as 8 to 20% of patients will develop post operative respiratory complications requiring medical intervention. The pre-operative risk factors that could predict respiratory complications retrospectively analyzed were young age, obesity and high preoperative apnea-hypopnea index. Despite the removal of obstructing lymphoid tissue, upper airway obstruction occurs on the first postoperative night in children with OSA. There is a debate regarding the post-operative duration and monitoring needed in children with OSA.

Hypothesis:

Pre-operative, operative and immediate post-operative parameters could predict post tonsillectomy respiratory complications.

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-12
• Study First Submitted: 2010-12-08
• Study First Submitted QC: 2010-12-08
• Last Update Submitted: 2010-12-08
• Study First Posted: 2010-12-09
• Last Update Posted: 2010-12-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Pediatric patient < 14 years old
2. Obstructive sleep apnea according to polysomnography
3. Surgery: Tonsillectomy/Tonsillotomy

Exclusion Criteria

1. Patient suffering from known respiratory disease

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
respiratory distress

Trial Locations

Locations (1)

Hadassah Medical Organization; 🇮🇱 Jerusalem, Israel