Factors Predictive of Adverse Postoperative Outcomes in Children Undergoing Tonsillectomy
25 januari 2018 uppdaterad av: Children's Hospital Medical Center, Cincinnati
Factors Predictive of Adverse Postoperative Outcomes in Children Undergoing
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.
Studieöversikt
Status
Avslutad
Betingelser
Detaljerad beskrivning
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.
Studietyp
Observationell
Inskrivning (Faktisk)
2400
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Ohio
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Cincinnati, Ohio, Förenta staterna, 45229-3026
- Cincinnati Children's Hospital Medical Center
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
Inte äldre än 17 år (Barn)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Testmetod
Icke-sannolikhetsprov
Studera befolkning
Children undergoing adenotonsillectomy in the United States
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: Endast fall
- Tidsperspektiv: Blivande
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
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Emergency Room Admissions
Tidsram: Upto 3 weeks after surgery
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Upto 3 weeks after surgery
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Postoperative Adverse Event
Tidsram: Assessed in post anesthesia care unit
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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.
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Assessed in post anesthesia care unit
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: Rajeev Subramanyam, MD, Children's Hospital Medical Center, Cincinnati
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Subramanyam R, Willging P, Ding L, Yang G, Varughese A. Factors Associated With Postadenotonsillectomy Unexpected Admissions in Children. Anesth Analg. 2021 Jun 1;132(6):1700-1709. doi: 10.1213/ANE.0000000000005123. Erratum In: Anesth Analg. 2022 May 1;134(5):e32.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 maj 2012
Primärt slutförande (Faktisk)
1 juni 2017
Avslutad studie (Faktisk)
1 november 2017
Studieregistreringsdatum
Först inskickad
17 augusti 2012
Först inskickad som uppfyllde QC-kriterierna
17 augusti 2012
Första postat (Uppskatta)
21 augusti 2012
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
29 januari 2018
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
25 januari 2018
Senast verifierad
1 januari 2018
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- 2012-0273
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