Risk Stratification of Post Tonsillectomy Respiratory Complications in the Pediatric Population
Recruitment status was Not yet recruiting
| Tracking Information | |||||||||
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| First Received Date ICMJE | December 8, 2010 | ||||||||
| Last Updated Date | December 8, 2010 | ||||||||
| Start Date ICMJE | Not Provided | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Current Primary Outcome Measures ICMJE |
respiratory distress | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Risk Stratification of Post Tonsillectomy Respiratory Complications in the Pediatric Population | ||||||||
| Official Title ICMJE | Not Provided | ||||||||
| 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. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Case-Crossover Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Probability Sample | ||||||||
| Study Population | children, suffering of obstructive sleep apnea, having their tonsills removed |
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| Condition ICMJE | Post Tonsillectomy Respiratory Complications | ||||||||
| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) | post tonsillectomy
children |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Not yet recruiting | ||||||||
| Estimated Enrollment ICMJE | 200 | ||||||||
| Completion Date | Not Provided | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: 1. Patient suffering from known respiratory disease |
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| Gender | Both | ||||||||
| Ages | up to 14 Years | ||||||||
| Accepts Healthy Volunteers | Not Provided | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Israel | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01257321 | ||||||||
| Other Study ID Numbers ICMJE | OSA-HMO-CTIL | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| Responsible Party | Not Provided | ||||||||
| Study Sponsor ICMJE | Hadassah Medical Organization | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE | Not Provided | ||||||||
| Information Provided By | Hadassah Medical Organization | ||||||||
| Verification Date | December 2010 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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