Risk Stratification of Post Tonsillectomy Respiratory Complications in the Pediatric Population

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

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

Purpose

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.

Condition
Post Tonsillectomy Respiratory Complications


Study Type:	Observational
Study Design:	Observational Model: Case-Crossover Time Perspective: Prospective

Resource links provided by NLM:

MedlinePlus related topics: Tonsillitis

U.S. FDA Resources

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:

respiratory distress


Estimated Enrollment:	200

Groups/Cohorts
post tonsillectomy children

Eligibility


Ages Eligible for Study:	up to 14 Years (Child)
Sexes Eligible for Study:	All
Sampling Method:	Probability Sample

Study Population

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

1. Patient suffering from known respiratory disease

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01257321

Contacts


Contact: Nir Hirshoren, MD	0097226776476	drnir@hadassah.org.il
Contact: Hadas Lemberg, PhD	00972267777572	lhadas@hadassah.org.il

Locations


Israel
Hadassah Medical Organization	Not yet recruiting
Jerusalem, Israel
Contact: Arik Tzukert, DMD 0097226776095 arik@hadassah.org.il

Sponsors and Collaborators

Hadassah Medical Organization

More Information


ClinicalTrials.gov Identifier:	NCT01257321 History of Changes
Other Study ID Numbers:	OSA-HMO-CTIL
Study First Received:	December 8, 2010
Last Updated:	December 8, 2010

ClinicalTrials.gov processed this record on June 23, 2017

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