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Risk Stratification of Post Tonsillectomy Respiratory Complications in the Pediatric Population

NCT ID: NCT01257321

Last Updated: 2010-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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Post Tonsillectomy Respiratory Complications

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Study Groups

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post tonsillectomy

children

No interventions assigned to this group

Eligibility Criteria

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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
Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hadassah Medical Organization

OTHER

Sponsor Role lead

Locations

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Hadassah Medical Organization

Jerusalem, , Israel

Site Status

Countries

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Israel

Central Contacts

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Nir Hirshoren, MD

Role: CONTACT

Phone: 0097226776476

Email: [email protected]

Hadas Lemberg, PhD

Role: CONTACT

Phone: 00972267777572

Email: [email protected]

Facility Contacts

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Arik Tzukert, DMD

Role: primary

Other Identifiers

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OSA-HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id