Does LMA Instead of ET Tube Affect Incidence of Postoperative Vomiting in Children Undergoing Strabismus Correction?

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by The University of Texas Health Science Center, Houston.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT00338559
First received: June 15, 2006
Last updated: May 3, 2011
Last verified: May 2011
  Purpose

The effect of airway management on vomiting after strabismus surgery is unknown. The purpose of this study is to find out whether the use of different airway devices, such as LMA, which is a special mask placed in the throat or Endotracheal tube (ET tube), which is a soft tube placed in the wind pipe, affects the incidence of vomiting after surgery. Two hundred six children between the ages of 2 and 12 years are expected to take part in this study.


Condition Phase
Strabismus
Phase 2

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Does Using Laryngeal Mask Airway (LMA) Instead of an Endotracheal Tube (ET Tube) Affect the Incidence of Postoperative Vomiting in Children Undergoing Strabismus Correction? - An Observational Study

Resource links provided by NLM:


Further study details as provided by The University of Texas Health Science Center, Houston:

Estimated Enrollment: 206
Study Start Date: May 2006
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
LMA group
Patients in which laryngeal mask airway (LMA) is used.
ET group
Patients in which endotracheal tube (ET) is used.

Detailed Description:

The child will be checked by the study doctor to determine if he/she qualifies to be part of the study. The study doctor may not want the child to take part in this study if he/she is currently in another research study; or if the child has been in any other research study within the last 30 days, or if the child is extremely obese, or has reflux or another GI problem.

If the child qualifies for the study, he/she will receive routine general anesthesia. For airway management, the child will have either a LMA or ET tube. The child has an equal chance of receiving either one of these airways devices, much like the coin flip.

After surgery, the child will be transferred to the recovery room (PACU). If the child vomits in PACU, he/she will receive rescue medication, which can be repeated if the need arises.

A research coordinator will call the parents the following day to find out whether the child vomited after leaving the hospital, in the car or at home, for any complications and receiving any medications.

  Eligibility

Ages Eligible for Study:   1 Year to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Two hundred six children between the ages of 1 and 12 years are expected to take part in this study.

Criteria

Inclusion Criteria:

  • Patients with Elective Uni- or Bilateral Strabismus repair

Exclusion Criteria:

  • ASA >2
  • History of Prematurity
  • History of Reflux
  • History of Neurological Disease
  • Difficult Airway
  • Obesity
  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: NCT00338559

Contacts
Contact: Samia Khalil, MD 713-500-6242 Samia.Khalil@uth.tmc.edu
Contact: Mohammed Ali, MD 713-500-6194 mohammed.ali@uth.tmc.edu

Locations
United States, Texas
Memorial Hermann Hospital Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Samia N Khalil, MD         
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
Principal Investigator: Samia N Khalil, MD University of Texas HSC at Houston
  More Information

No publications provided

Responsible Party: Samia N. Khalil, M.D., University of Texas Health Science Center
ClinicalTrials.gov Identifier: NCT00338559     History of Changes
Other Study ID Numbers: HSC-MS-06-0059
Study First Received: June 15, 2006
Last Updated: May 3, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center, Houston:
Strabismus
LMA
ET Tube
POV

Additional relevant MeSH terms:
Strabismus
Postoperative Nausea and Vomiting
Ocular Motility Disorders
Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases
Postoperative Complications
Pathologic Processes
Nausea
Signs and Symptoms, Digestive
Signs and Symptoms
Vomiting

ClinicalTrials.gov processed this record on July 29, 2014