Study Results
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Basic Information
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COMPLETED
1154 participants
OBSERVATIONAL
2024-04-23
2024-05-30
Brief Summary
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All 1154 patients in the FDP-PONV trial will be enrolled in this study. Delayed CIPONV is defined as experiencing CIPONV between 25-120 hours after surgery. After selecting the modeling variables from 81 perioperative clinical features, six machine learning models are established to generate the risk prediction models for delayed CIPONV. The area under the receiver operating characteristic curve, accuracy, sensitivity, specificity, positive predictive value, negative predictive value, F1 score and Brier score are used to evaluate the model performance. Shape Additive explanation analysis was conducted to evaluate feature importance.
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Detailed Description
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A total of 81 variables, including demographics, comorbidities, laboratory findings, as well as information related to anesthesia and surgery, are prospectively collected in the FDP-PONV trial and considered as potential predictive factors in this study. The least absolute shrinkage and selection operator method is used to identify clinically significant variables. Further selection of the final predictors is performed using stepwise regression based on the Akaike Information Criterion.
The entire dataset is randomly divided into a training set and a validation set in a ratio of 7:3. Six machine learning models, namely logistic regression, random, extreme gradient boosting, k-nearest neighbor, gradient boosting decision, and multi-layer perceptron, were developed to create risk prediction models for delayed CIPONV. The performance of the models is assessed by comparing the area under the receiver operating characteristic curve, accuracy, sensitivity, specificity, positive predictive value, negative predictive value, F1 score, Brier score and calibration curve. Bootstrap resamples is conducted 1000 times on the training cohort to evaluate the predictive model's performance. Decision curve analysis is conducted to assess the clinical applicability of the model. The SHapley Additive Explanations library (SHAP) is used to interpret the prediction model.
Conditions
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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Delayed CIPONV
Patients experiencing CIPONV between 25 and 120 hours post-surgery.
No intervention
This is a secondary analysis and no intervention is implemented.
Non-delayed CIPONV
Patients not experiencing CIPONV between 25 and 120 hours after surgery.
No intervention
This is a secondary analysis and no intervention is implemented.
Interventions
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No intervention
This is a secondary analysis and no intervention is implemented.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
75 Years
ALL
No
Sponsors
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Sixth Affiliated Hospital, Sun Yat-sen University
OTHER
Responsible Party
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Zhi-Nan Zheng
Attending doctor
Principal Investigators
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Zhinan Zheng, MD
Role: PRINCIPAL_INVESTIGATOR
The Sixth Affiliated Hospital, Sun Yat-sen University
Locations
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Department of Anesthesia, The Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Countries
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References
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Apfel CC, Laara E, Koivuranta M, Greim CA, Roewer N. A simplified risk score for predicting postoperative nausea and vomiting: conclusions from cross-validations between two centers. Anesthesiology. 1999 Sep;91(3):693-700. doi: 10.1097/00000542-199909000-00022.
Myles PS, Wengritzky R. Simplified postoperative nausea and vomiting impact scale for audit and post-discharge review. Br J Anaesth. 2012 Mar;108(3):423-9. doi: 10.1093/bja/aer505. Epub 2012 Jan 29.
Nino MC, Calle S, Ruiz D, Baron MA, Cohen D, Martinez JE, Benitez DS, Mejia JA, Guerra JD, Kattah L. Rethinking postoperative nausea and vomiting prevention beyond perioperative medications. J Clin Anesth. 2024 Aug;95:111457. doi: 10.1016/j.jclinane.2024.111457. Epub 2024 Mar 29. No abstract available.
Chow R, Navari RM, Terry B, DeAngelis C, Prsic EH. Olanzapine 5 mg vs 10 mg for the prophylaxis of chemotherapy-induced nausea and vomiting: a network meta-analysis. Support Care Cancer. 2022 Feb;30(2):1015-1018. doi: 10.1007/s00520-021-06606-x. No abstract available.
White PF, Sacan O, Nuangchamnong N, Sun T, Eng MR. The relationship between patient risk factors and early versus late postoperative emetic symptoms. Anesth Analg. 2008 Aug;107(2):459-63. doi: 10.1213/ane.0b013e31817aa6e4.
Mraovic B, Simurina T. Effects of an intravenous lidocaine bolus before tracheal extubation on recovery after breast surgery - Lidocaine at the End (LATE) study: a randomized controlled clinical trial. Croat Med J. 2023 Aug 31;64(4):222-230. doi: 10.3325/cmj.2023.64.222.
Hermans V, De Pooter F, De Groote F, De Hert S, Van der Linden P. Effect of dexamethasone on nausea, vomiting, and pain in paediatric tonsillectomy. Br J Anaesth. 2012 Sep;109(3):427-31. doi: 10.1093/bja/aes249.
Gan TJ, Gu J, Singla N, Chung F, Pearman MH, Bergese SD, Habib AS, Candiotti KA, Mo Y, Huyck S, Creed MR, Cantillon M; Rolapitant Investigation Group. Rolapitant for the prevention of postoperative nausea and vomiting: a prospective, double-blinded, placebo-controlled randomized trial. Anesth Analg. 2011 Apr;112(4):804-12. doi: 10.1213/ANE.0b013e31820886c3. Epub 2011 Mar 8.
Mc Loughlin S, Terrasa SA, Ljungqvist O, Sanchez G, Garcia Fornari G, Alvarez AO. Nausea and vomiting in a colorectal ERAS program: Impact on nutritional recovery and the length of hospital stay. Clin Nutr ESPEN. 2019 Dec;34:73-80. doi: 10.1016/j.clnesp.2019.08.010. Epub 2019 Sep 11.
Other Identifiers
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2024ZSLYEC-202
Identifier Type: -
Identifier Source: org_study_id
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