Factors Predictive of Adverse Postoperative Outcomes in Children Undergoing Tonsillectomy
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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 |
- 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.
- 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) |
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 |
Children undergoing adenotonsillectomy in the United States
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| United States, Ohio | |
| Cincinnati Children's Hospital Medical Center | |
| Cincinnati, Ohio, United States, 45229-3026 | |
| 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 May 16, 2013