<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01669993</url>
  </required_header>
  <id_info>
    <org_study_id>2012-0273</org_study_id>
    <nct_id>NCT01669993</nct_id>
  </id_info>
  <brief_title>Factors Predictive of Adverse Postoperative Outcomes in Children Undergoing Tonsillectomy</brief_title>
  <official_title>Factors Predictive of Adverse Postoperative Outcomes in Children Undergoing</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Children's Hospital Medical Center, Cincinnati</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Children's Hospital Medical Center, Cincinnati</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purposes of the study are to identify 1) the patient (demographic and clinical) and&#xD;
      health care system factors predictive of immediate and late postoperative adverse outcomes in&#xD;
      children undergoing tonsillectomy. 2) Evaluate the preoperative use of the sleep&#xD;
      questionnaire to identify children at risk for immediate and late postoperative adverse&#xD;
      outcomes in children undergoing tonsillectomy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Currently, children are scheduled to go home or stay in the hospital depending on expert&#xD;
      consensus and institutional guidelines. The investigators preliminary experience (Dr.&#xD;
      Sadhasivam PI: IRB No. 2008-0848) with the pharmocogenetic study, studying the phenotypic and&#xD;
      genotypic influences of pain and use of opioids in patients undergoing tonsillectomy&#xD;
      indicates that a significant number of patients scheduled as outpatients experience prolonged&#xD;
      recovery phases in the PACU, some of whom are admitted or re-admitted following discharge.&#xD;
      The identification of those factors that are, predictive of adverse events in tonsillectomy&#xD;
      patients and the development of a prototype prediction model in this single-center study to&#xD;
      support clinical decision-making. The rationale of this project is that developing a model to&#xD;
      predict postoperative adverse events will not only lead to improved clinical outcomes and&#xD;
      enhance patient safety, but also reduce family psychosocial distress associated with&#xD;
      unanticipated hospital visits or re-admission, while reducing the burden on the health care&#xD;
      system.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2012</start_date>
  <completion_date type="Actual">November 2017</completion_date>
  <primary_completion_date type="Actual">June 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Emergency Room Admissions</measure>
    <time_frame>Upto 3 weeks after surgery</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Postoperative Adverse Event</measure>
    <time_frame>Assessed in post anesthesia care unit</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <enrollment type="Actual">2400</enrollment>
  <condition>Tonsillectomy Postoperative Adverse Events</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Children undergoing adenotonsillectomy in the United States&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children 0-17 years of age&#xD;
&#xD;
          -  Children scheduled for tonsillectomy or adeno-tonsillectomy&#xD;
&#xD;
          -  ASA I, II, or III&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  ASA IV and V&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rajeev Subramanyam, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Children's Hospital Medical Center, Cincinnati</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cincinnati Children's Hospital Medical Center</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45229-3026</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Jaryszak EM, Lander L, Patel AK, Choi SS, Shah RK. Prolonged recovery after out-patient pediatric adenotonsillectomy. Int J Pediatr Otorhinolaryngol. 2011 Apr;75(4):585-8. doi: 10.1016/j.ijporl.2011.01.024. Epub 2011 Feb 15.</citation>
    <PMID>21324535</PMID>
  </reference>
  <reference>
    <citation>Bhattacharyya N, Lin HW. Changes and consistencies in the epidemiology of pediatric adenotonsillar surgery, 1996-2006. Otolaryngol Head Neck Surg. 2010 Nov;143(5):680-4. doi: 10.1016/j.otohns.2010.06.918.</citation>
    <PMID>20974339</PMID>
  </reference>
  <reference>
    <citation>Morris LG, Lieberman SM, Reitzen SD, Edelstein DR, Ziff DJ, Katz A, Komisar A. Characteristics and outcomes of malpractice claims after tonsillectomy. Otolaryngol Head Neck Surg. 2008 Mar;138(3):315-20. doi: 10.1016/j.otohns.2007.11.024.</citation>
    <PMID>18312878</PMID>
  </reference>
  <reference>
    <citation>Stevenson AN, Myer CM 3rd, Shuler MD, Singer PS. Complications and legal outcomes of tonsillectomy malpractice claims. Laryngoscope. 2012 Jan;122(1):71-4. doi: 10.1002/lary.22438. Epub 2011 Nov 10.</citation>
    <PMID>22076638</PMID>
  </reference>
  <reference>
    <citation>Richmond KH, Wetmore RF, Baranak CC. Postoperative complications following tonsillectomy and adenoidectomy--who is at risk? Int J Pediatr Otorhinolaryngol. 1987 Aug;13(2):117-24. doi: 10.1016/0165-5876(87)90088-7.</citation>
    <PMID>3667091</PMID>
  </reference>
  <reference>
    <citation>Raghavendran S, Bagry H, Detheux G, Zhang X, Brouillette RT, Brown KA. An anesthetic management protocol to decrease respiratory complications after adenotonsillectomy in children with severe sleep apnea. Anesth Analg. 2010 Apr 1;110(4):1093-101. doi: 10.1213/ANE.0b013e3181cfc435. Epub 2010 Feb 8.</citation>
    <PMID>20142343</PMID>
  </reference>
  <reference>
    <citation>Brown KA. Outcome, risk, and error and the child with obstructive sleep apnea. Paediatr Anaesth. 2011 Jul;21(7):771-80. doi: 10.1111/j.1460-9592.2011.03597.x. Epub 2011 May 3.</citation>
    <PMID>21539679</PMID>
  </reference>
  <reference>
    <citation>Boss EF, Marsteller JA, Simon AE. Outpatient tonsillectomy in children: demographic and geographic variation in the United States, 2006. J Pediatr. 2012 May;160(5):814-9. doi: 10.1016/j.jpeds.2011.11.041. Epub 2011 Dec 17.</citation>
    <PMID>22183449</PMID>
  </reference>
  <reference>
    <citation>Chervin RD, Hedger K, Dillon JE, Pituch KJ. Pediatric sleep questionnaire (PSQ): validity and reliability of scales for sleep-disordered breathing, snoring, sleepiness, and behavioral problems. Sleep Med. 2000 Feb 1;1(1):21-32. doi: 10.1016/s1389-9457(99)00009-x.</citation>
    <PMID>10733617</PMID>
  </reference>
  <reference>
    <citation>Audit NP. Impact of NICE guidance on rates of haemorrhage after tonsillectomy: an evaluation of guidance issued during an ongoing national tonsillectomy audit. Qual Saf Health Care. 2008 Aug;17(4):264-8. doi: 10.1136/qshc.2006.021386.</citation>
    <PMID>18678723</PMID>
  </reference>
  <reference>
    <citation>Zhao YC, Berkowitz RG. Prolonged hospitalization following tonsillectomy in healthy children. Int J Pediatr Otorhinolaryngol. 2006 Nov;70(11):1885-9. doi: 10.1016/j.ijporl.2006.06.015. Epub 2006 Aug 17.</citation>
    <PMID>16919338</PMID>
  </reference>
  <reference>
    <citation>Mitchell RB, Kelly J. Behavior, neurocognition and quality-of-life in children with sleep-disordered breathing. Int J Pediatr Otorhinolaryngol. 2006 Mar;70(3):395-406. doi: 10.1016/j.ijporl.2005.10.020.</citation>
    <PMID>16321451</PMID>
  </reference>
  <reference>
    <citation>Tunkel DE. Polysomnography before tonsillectomy in children: who and when? Otolaryngol Head Neck Surg. 2012 Feb;146(2):191-3; discussion 194-5. doi: 10.1177/0194599811429236. Epub 2011 Nov 16.</citation>
    <PMID>22095954</PMID>
  </reference>
  <reference>
    <citation>Chervin RD, Weatherly RA, Garetz SL, Ruzicka DL, Giordani BJ, Hodges EK, Dillon JE, Guire KE. Pediatric sleep questionnaire: prediction of sleep apnea and outcomes. Arch Otolaryngol Head Neck Surg. 2007 Mar;133(3):216-22. doi: 10.1001/archotol.133.3.216.</citation>
    <PMID>17372077</PMID>
  </reference>
  <reference>
    <citation>Shapiro NL, Seid AB, Pransky SM, Kearns DB, Magit AE, Silva P. Adenotonsillectomy in the very young patient: cost analysis of two methods of postoperative care. Int J Pediatr Otorhinolaryngol. 1999 May 5;48(2):109-15. doi: 10.1016/s0165-5876(99)00011-7.</citation>
    <PMID>10375035</PMID>
  </reference>
  <reference>
    <citation>Baugh RF, Archer SM, Mitchell RB, Rosenfeld RM, Amin R, Burns JJ, Darrow DH, Giordano T, Litman RS, Li KK, Mannix ME, Schwartz RH, Setzen G, Wald ER, Wall E, Sandberg G, Patel MM; American Academy of Otolaryngology-Head and Neck Surgery Foundation. Clinical practice guideline: tonsillectomy in children. Otolaryngol Head Neck Surg. 2011 Jan;144(1 Suppl):S1-30. doi: 10.1177/0194599810389949.</citation>
    <PMID>21493257</PMID>
  </reference>
  <reference>
    <citation>Varughese AM, Morillo-Delerme J, Kurth CD. Quality management in the delivery of pediatric anesthesia care. Int Anesthesiol Clin. 2006 Winter;44(1):119-39. doi: 10.1097/01.aia.0000196253.46033.f9. No abstract available.</citation>
    <PMID>16394837</PMID>
  </reference>
  <reference>
    <citation>Varughese AM, Nick TG, Gunter J, Wang Y, Kurth CD. Factors predictive of poor behavioral compliance during inhaled induction in children. Anesth Analg. 2008 Aug;107(2):413-21. doi: 10.1213/ane.0b013e31817e616b.</citation>
    <PMID>18633018</PMID>
  </reference>
  <reference>
    <citation>Brigger MT, Brietzke SE. Outpatient tonsillectomy in children: a systematic review. Otolaryngol Head Neck Surg. 2006 Jul;135(1):1-7. doi: 10.1016/j.otohns.2006.02.036.</citation>
    <PMID>16815173</PMID>
  </reference>
  <reference>
    <citation>Raeder J. Ambulatory anesthesia aspects for tonsillectomy and abrasion in children. Curr Opin Anaesthesiol. 2011 Dec;24(6):620-6. doi: 10.1097/ACO.0b013e32834b9482.</citation>
    <PMID>21897214</PMID>
  </reference>
  <reference>
    <citation>Sadhasivam S, Chidambaran V, Ngamprasertwong P, Esslinger HR, Prows C, Zhang X, Martin LJ, McAuliffe J. Race and unequal burden of perioperative pain and opioid related adverse effects in children. Pediatrics. 2012 May;129(5):832-8. doi: 10.1542/peds.2011-2607. Epub 2012 Apr 23.</citation>
    <PMID>22529273</PMID>
  </reference>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>August 17, 2012</study_first_submitted>
  <study_first_submitted_qc>August 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 21, 2012</study_first_posted>
  <last_update_submitted>January 25, 2018</last_update_submitted>
  <last_update_submitted_qc>January 25, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 29, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Outcomes</keyword>
  <keyword>Quality improvement</keyword>
  <keyword>Patient Safety</keyword>
  <keyword>PACU</keyword>
  <keyword>Complications</keyword>
  <keyword>Adverse events</keyword>
  <keyword>Respiratory arrest</keyword>
  <keyword>Pain</keyword>
  <keyword>PONV</keyword>
  <keyword>Age</keyword>
  <keyword>Neonate</keyword>
  <keyword>Infant</keyword>
  <keyword>Child</keyword>
  <keyword>Ambulatory</keyword>
  <keyword>Inpatient</keyword>
  <keyword>General Anesthesia</keyword>
  <keyword>Otolaryngology</keyword>
  <keyword>Tonsillectomy</keyword>
  <keyword>Obstructive sleep apnea</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01669993
org study id: 2012-0273
nct id: NCT01669993
lead sponsor: 
has dmc: Yes
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.
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.
observational model: Case-Only
time perspective: Prospective
measure: Emergency Room Admissions
time frame: Upto 3 weeks after surgery
measure: Postoperative Adverse Event
time frame: Assessed in post anesthesia care unit
description: 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.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 17 Years
healthy volunteers: No
last name: Rajeev Subramanyam, MD
role: Principal Investigator
affiliation: Children's Hospital Medical Center, Cincinnati
facility: 
country: United States
citation: Jaryszak EM, Lander L, Patel AK, Choi SS, Shah RK. Prolonged recovery after out-patient pediatric adenotonsillectomy. Int J Pediatr Otorhinolaryngol. 2011 Apr;75(4):585-8. doi: 10.1016/j.ijporl.2011.01.024. Epub 2011 Feb 15.
PMID: 21324535
citation: Bhattacharyya N, Lin HW. Changes and consistencies in the epidemiology of pediatric adenotonsillar surgery, 1996-2006. Otolaryngol Head Neck Surg. 2010 Nov;143(5):680-4. doi: 10.1016/j.otohns.2010.06.918.
PMID: 20974339
citation: Morris LG, Lieberman SM, Reitzen SD, Edelstein DR, Ziff DJ, Katz A, Komisar A. Characteristics and outcomes of malpractice claims after tonsillectomy. Otolaryngol Head Neck Surg. 2008 Mar;138(3):315-20. doi: 10.1016/j.otohns.2007.11.024.
PMID: 18312878
citation: Stevenson AN, Myer CM 3rd, Shuler MD, Singer PS. Complications and legal outcomes of tonsillectomy malpractice claims. Laryngoscope. 2012 Jan;122(1):71-4. doi: 10.1002/lary.22438. Epub 2011 Nov 10.
PMID: 22076638
citation: Richmond KH, Wetmore RF, Baranak CC. Postoperative complications following tonsillectomy and adenoidectomy--who is at risk? Int J Pediatr Otorhinolaryngol. 1987 Aug;13(2):117-24. doi: 10.1016/0165-5876(87)90088-7.
PMID: 3667091
citation: Raghavendran S, Bagry H, Detheux G, Zhang X, Brouillette RT, Brown KA. An anesthetic management protocol to decrease respiratory complications after adenotonsillectomy in children with severe sleep apnea. Anesth Analg. 2010 Apr 1;110(4):1093-101. doi: 10.1213/ANE.0b013e3181cfc435. Epub 2010 Feb 8.
PMID: 20142343
citation: Brown KA. Outcome, risk, and error and the child with obstructive sleep apnea. Paediatr Anaesth. 2011 Jul;21(7):771-80. doi: 10.1111/j.1460-9592.2011.03597.x. Epub 2011 May 3.
PMID: 21539679
citation: Boss EF, Marsteller JA, Simon AE. Outpatient tonsillectomy in children: demographic and geographic variation in the United States, 2006. J Pediatr. 2012 May;160(5):814-9. doi: 10.1016/j.jpeds.2011.11.041. Epub 2011 Dec 17.
PMID: 22183449
citation: Chervin RD, Hedger K, Dillon JE, Pituch KJ. Pediatric sleep questionnaire (PSQ): validity and reliability of scales for sleep-disordered breathing, snoring, sleepiness, and behavioral problems. Sleep Med. 2000 Feb 1;1(1):21-32. doi: 10.1016/s1389-9457(99)00009-x.
PMID: 10733617
citation: Audit NP. Impact of NICE guidance on rates of haemorrhage after tonsillectomy: an evaluation of guidance issued during an ongoing national tonsillectomy audit. Qual Saf Health Care. 2008 Aug;17(4):264-8. doi: 10.1136/qshc.2006.021386.
PMID: 18678723
citation: Zhao YC, Berkowitz RG. Prolonged hospitalization following tonsillectomy in healthy children. Int J Pediatr Otorhinolaryngol. 2006 Nov;70(11):1885-9. doi: 10.1016/j.ijporl.2006.06.015. Epub 2006 Aug 17.
PMID: 16919338
citation: Mitchell RB, Kelly J. Behavior, neurocognition and quality-of-life in children with sleep-disordered breathing. Int J Pediatr Otorhinolaryngol. 2006 Mar;70(3):395-406. doi: 10.1016/j.ijporl.2005.10.020.
PMID: 16321451
citation: Tunkel DE. Polysomnography before tonsillectomy in children: who and when? Otolaryngol Head Neck Surg. 2012 Feb;146(2):191-3; discussion 194-5. doi: 10.1177/0194599811429236. Epub 2011 Nov 16.
PMID: 22095954
citation: Chervin RD, Weatherly RA, Garetz SL, Ruzicka DL, Giordani BJ, Hodges EK, Dillon JE, Guire KE. Pediatric sleep questionnaire: prediction of sleep apnea and outcomes. Arch Otolaryngol Head Neck Surg. 2007 Mar;133(3):216-22. doi: 10.1001/archotol.133.3.216.
PMID: 17372077
citation: Shapiro NL, Seid AB, Pransky SM, Kearns DB, Magit AE, Silva P. Adenotonsillectomy in the very young patient: cost analysis of two methods of postoperative care. Int J Pediatr Otorhinolaryngol. 1999 May 5;48(2):109-15. doi: 10.1016/s0165-5876(99)00011-7.
PMID: 10375035
citation: Baugh RF, Archer SM, Mitchell RB, Rosenfeld RM, Amin R, Burns JJ, Darrow DH, Giordano T, Litman RS, Li KK, Mannix ME, Schwartz RH, Setzen G, Wald ER, Wall E, Sandberg G, Patel MM; American Academy of Otolaryngology-Head and Neck Surgery Foundation. Clinical practice guideline: tonsillectomy in children. Otolaryngol Head Neck Surg. 2011 Jan;144(1 Suppl):S1-30. doi: 10.1177/0194599810389949.
PMID: 21493257
citation: Varughese AM, Morillo-Delerme J, Kurth CD. Quality management in the delivery of pediatric anesthesia care. Int Anesthesiol Clin. 2006 Winter;44(1):119-39. doi: 10.1097/01.aia.0000196253.46033.f9. No abstract available.
PMID: 16394837
citation: Varughese AM, Nick TG, Gunter J, Wang Y, Kurth CD. Factors predictive of poor behavioral compliance during inhaled induction in children. Anesth Analg. 2008 Aug;107(2):413-21. doi: 10.1213/ane.0b013e31817e616b.
PMID: 18633018
citation: Brigger MT, Brietzke SE. Outpatient tonsillectomy in children: a systematic review. Otolaryngol Head Neck Surg. 2006 Jul;135(1):1-7. doi: 10.1016/j.otohns.2006.02.036.
PMID: 16815173
citation: Raeder J. Ambulatory anesthesia aspects for tonsillectomy and abrasion in children. Curr Opin Anaesthesiol. 2011 Dec;24(6):620-6. doi: 10.1097/ACO.0b013e32834b9482.
PMID: 21897214
citation: Sadhasivam S, Chidambaran V, Ngamprasertwong P, Esslinger HR, Prows C, Zhang X, Martin LJ, McAuliffe J. Race and unequal burden of perioperative pain and opioid related adverse effects in children. Pediatrics. 2012 May;129(5):832-8. doi: 10.1542/peds.2011-2607. Epub 2012 Apr 23.
PMID: 22529273
responsible party type: Sponsor