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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:
ClinicalTrials.gov Identifier:
NCT01257321
First Posted: December 9, 2010
Last Update Posted: December 9, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hadassah Medical Organization
  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:


Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • respiratory distress

Estimated Enrollment: 200
Groups/Cohorts
post tonsillectomy
children

  Eligibility

Information from the National Library of Medicine

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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:

  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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: December 8, 2010
First Posted: December 9, 2010
Last Update Posted: December 9, 2010
Last Verified: December 2010