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Risk Stratification of Post Tonsillectomy Respiratory Complications in the Pediatric Population

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by Hadassah Medical Organization.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01257321
First received: December 8, 2010
Last updated: NA
Last verified: December 2010
History: No changes posted

December 8, 2010
December 8, 2010
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respiratory distress
Same as current
No Changes Posted
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Risk Stratification of Post Tonsillectomy Respiratory Complications in the Pediatric Population
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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.

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Observational
Observational Model: Case-Crossover
Time Perspective: Prospective
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Probability Sample

children, suffering of obstructive sleep apnea, having their tonsills removed

Post Tonsillectomy Respiratory Complications
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post tonsillectomy
children
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
200
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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

Both
up to 14 Years
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Contact: Nir Hirshoren, MD 0097226776476 drnir@hadassah.org.il
Contact: Hadas Lemberg, PhD 00972267777572 lhadas@hadassah.org.il
Israel
 
NCT01257321
OSA-HMO-CTIL
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Hadassah Medical Organization
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Hadassah Medical Organization
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP