Post Tonsillectomy Respiratory Complications Clinical Trial
| NCT number | NCT01257321 |
| Other study ID # | OSA-HMO-CTIL |
| Secondary ID | |
| Status | Not yet recruiting |
| Phase | N/A |
| First received | December 8, 2010 |
| Last updated | December 8, 2010 |
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.
| Status | Not yet recruiting |
| Enrollment | 200 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | |
| Gender | Both |
| Age group | N/A to 14 Years |
| Eligibility |
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 |
Observational Model: Case-Crossover, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Israel | Hadassah Medical Organization | Jerusalem |
| Lead Sponsor | Collaborator |
|---|---|
| Hadassah Medical Organization |
Israel,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | respiratory distress |