Factors Predictive of Adverse Postoperative Outcomes in Children Undergoing Tonsillectomy

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:
NCT01669993
First received: August 17, 2012
Last updated: NA
Last verified: August 2012
History: No changes posted
  Purpose

The purposes of the study are to identify 1) the patient (demographic and clinical) and health care system factors predictive of immediate and late postoperative adverse outcomes in children undergoing tonsillectomy. 2) Evaluate the preoperative use of the sleep questionnaire to identify children at risk for immediate and late postoperative adverse outcomes in children undergoing tonsillectomy.


Condition
Tonsillectomy Postoperative Adverse Events

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Factors Predictive of Adverse Postoperative Outcomes in Children Undergoing

Resource links provided by NLM:


Further study details as provided by Children's Hospital Medical Center, Cincinnati:

Primary Outcome Measures:
  • Immediate postoperative adverse event [ Time Frame: Post-anesthetic recovery room (PACU), an expected average of 2 hours ] [ Designated as safety issue: Yes ]
    This will be measured in post anesthesia care unit (PACU) and will be a composite measure of any one or a combination of these: desaturation, somnolence, laryngospasm /airway obstruction, airway instrumentation, drug administration, PACU discharge criteria not met, unanticipated hospital or ICU admission.


Secondary Outcome Measures:
  • Late Postoperative Adverse Event [ Time Frame: Assessed at 24 h and 3 weeks post discharge ] [ Designated as safety issue: No ]
    Assessed by electronic chart review and telephonic call to the families. The variables of interest are: Unanticipated hospital readmission, ICU admission, ER visit.


Estimated Enrollment: 2000
Study Start Date: May 2012
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Detailed Description:

Currently, children are scheduled to go home or stay in the hospital depending on expert consensus and institutional guidelines. The investigators preliminary experience (Dr. Sadhasivam PI: IRB No. 2008-0848) with the pharmocogenetic study, studying the phenotypic and genotypic influences of pain and use of opioids in patients undergoing tonsillectomy indicates that a significant number of patients scheduled as outpatients experience prolonged recovery phases in the PACU, some of whom are admitted or re-admitted following discharge. The identification of those factors that are, predictive of adverse events in tonsillectomy patients and the development of a prototype prediction model in this single-center study to support clinical decision-making. The rationale of this project is that developing a model to predict postoperative adverse events will not only lead to improved clinical outcomes and enhance patient safety, but also reduce family psychosocial distress associated with unanticipated hospital visits or re-admission, while reducing the burden on the health care system.

  Eligibility

Ages Eligible for Study:   up to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Children undergoing adenotonsillectomy in the United States

Criteria

Inclusion Criteria:

  • Children 0-17 years of age
  • Children scheduled for tonsillectomy or adeno-tonsillectomy
  • ASA I, II, or III

Exclusion Criteria:

  • ASA IV and V
  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: NCT01669993

Locations
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229-3026
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Investigators
Principal Investigator: Rajeev Subramanyam, MD Children's Hospital Medical Center, Cincinnati
  More Information

Publications:

Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT01669993     History of Changes
Other Study ID Numbers: 2012-0273
Study First Received: August 17, 2012
Last Updated: August 17, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital Medical Center, Cincinnati:
Outcomes
Quality improvement
Patient Safety
PACU
Complications
Adverse events
Respiratory arrest
Pain
PONV
Age
Neonate
Infant
Child
Ambulatory
Inpatient
General Anesthesia
Otolaryngology
Tonsillectomy
Obstructive sleep apnea

ClinicalTrials.gov processed this record on October 29, 2014