Ignite Creation Date:
2025-12-26 @ 12:15 PM
Ignite Modification Date:
2026-03-02 @ 6:44 PM
Study NCT ID:
NCT03585400
Status:
COMPLETED
Last Update Posted:
2021-01-26
First Post:
2018-06-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of the REPS Prediction Tool
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055191', 'term': 'Delayed Emergence from Anesthesia'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019370', 'term': 'Observation'}], 'ancestors': [{'id': 'D008722', 'term': 'Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 101510}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-25', 'studyFirstSubmitDate': '2018-06-29', 'studyFirstSubmitQcDate': '2018-07-11', 'lastUpdatePostDateStruct': {'date': '2021-01-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Hospital Readmission', 'timeFrame': 'Up to 30 days after discharge', 'description': 'Hospital readmission defined as any admission to BIDMC.'}, {'measure': 'Hospital Length of Stay', 'timeFrame': 'During hospital stay, on average 4 days, and no longer than 1 year', 'description': 'Hospital length of stay defined as the number of days elapsed from hospital admission to hospital discharge.'}], 'primaryOutcomes': [{'measure': 'Postoperative Respiratory Complications (PRC)', 'timeFrame': 'After extubation, up to 7 days after surgery', 'description': 'PRC composite of invasive mechanical ventilation requirement within 7 postoperative days or immediate post-extubation desaturation (SpO2 \\<90%) within 10 minutes.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Neuromuscular Blockade Agents', 'Neuromuscular Blockade Reversal', 'Perioperative Care', 'Quality Improvement', 'Respiratory Complication'], 'conditions': ['Residual Neuromuscular Blockade', 'Curarization, Postoperative Residual', 'Postoperative Respiratory Complication']}, 'referencesModule': {'references': [{'pmid': '28806470', 'type': 'BACKGROUND', 'citation': 'Hristovska AM, Duch P, Allingstrup M, Afshari A. Efficacy and safety of sugammadex versus neostigmine in reversing neuromuscular blockade in adults. Cochrane Database Syst Rev. 2017 Aug 14;8(8):CD012763. doi: 10.1002/14651858.CD012763.'}, {'pmid': '25935840', 'type': 'BACKGROUND', 'citation': 'Brueckmann B, Sasaki N, Grobara P, Li MK, Woo T, de Bie J, Maktabi M, Lee J, Kwo J, Pino R, Sabouri AS, McGovern F, Staehr-Rye AK, Eikermann M. Effects of sugammadex on incidence of postoperative residual neuromuscular blockade: a randomized, controlled study. Br J Anaesth. 2015 Nov;115(5):743-51. doi: 10.1093/bja/aev104. Epub 2015 May 2.'}, {'pmid': '23757472', 'type': 'BACKGROUND', 'citation': 'Kotake Y, Ochiai R, Suzuki T, Ogawa S, Takagi S, Ozaki M, Nakatsuka I, Takeda J. Reversal with sugammadex in the absence of monitoring did not preclude residual neuromuscular block. Anesth Analg. 2013 Aug;117(2):345-51. doi: 10.1213/ANE.0b013e3182999672. Epub 2013 Jun 11.'}, {'type': 'BACKGROUND', 'citation': 'Intercontinental Marketing Services (IMS) Health, Multinational Integrated Data Analysis System (MIDAS), September 2010'}, {'pmid': '25919486', 'type': 'BACKGROUND', 'citation': 'McLean DJ, Diaz-Gil D, Farhan HN, Ladha KS, Kurth T, Eikermann M. Dose-dependent Association between Intermediate-acting Neuromuscular-blocking Agents and Postoperative Respiratory Complications. Anesthesiology. 2015 Jun;122(6):1201-13. doi: 10.1097/ALN.0000000000000674.'}, {'pmid': '29974459', 'type': 'BACKGROUND', 'citation': 'Rudolph MI, Chitilian HV, Ng PY, Timm FP, Agarwala AV, Doney AB, Ramachandran SK, Houle TT, Eikermann M. Implementation of a new strategy to improve the peri-operative management of neuromuscular blockade and its effects on postoperative pulmonary complications. Anaesthesia. 2018 Sep;73(9):1067-1078. doi: 10.1111/anae.14326. Epub 2018 Jul 4.'}, {'pmid': '30020144', 'type': 'BACKGROUND', 'citation': 'Rudolph MI, Ng PY, Deng H, Scheffenbichler FT, Grabitz SD, Wanderer JP, Houle TT, Eikermann M. Comparison of a novel clinical score to estimate the risk of REsidual neuromuscular block Prediction Score and the last train-of-four count documented in the electronic anaesthesia record: A retrospective cohort study of electronic data on file. Eur J Anaesthesiol. 2018 Nov;35(11):883-892. doi: 10.1097/EJA.0000000000000861.'}, {'pmid': '33497061', 'type': 'DERIVED', 'citation': 'Patrocinio MD, Shay D, Rudolph MI, Santer P, Grabitz SD, Xu X, Nabel S, Bose S, Eikermann M. REsidual Neuromuscular Block Prediction Score Versus Train-of-Four Ratio and Respiratory Outcomes: A Retrospective Cohort Study. Anesth Analg. 2021 Sep 1;133(3):610-619. doi: 10.1213/ANE.0000000000005363.'}]}, 'descriptionModule': {'briefSummary': "Neuromuscular blocking agents' (NMBA) use during surgery is associated with postoperative respiratory complications and increased risk of readmission to the hospital following ambulatory surgery. Residual neuromuscular block (rNMB) after surgery is difficult to identify. We have recently developed the REsidual neuromuscular block Prediction Score (REPS), that predicts the risk for postoperative rNMB. Our primary objective is now to assess the predictive ability of the REPS for respiratory complications within seven days following general anaesthesia. The secondary objective is to compare the predictive values of REPS and train-of-four (TOF)-ratio below 0.90 for respiratory complications.", 'detailedDescription': 'Residual neuromuscular blockade occurs in about 20-60% of patients and depends on compound and dose of NMBA reversal agent used. While on the one hand, NMBAs optimize surgical conditions and facilitate mechanical ventilation in patients with ventilator asynchrony, on the other hand, these agents have been associated with respiratory complications and increased risk of readmission after ambulatory surgery. A consensus in regard to guidelines and thresholds to define the optimal strategy to optimize surgical conditions is yet to be achieved. We have shown that utilization of non-depolarizing muscle relaxants and their reversal agents can be improved by dedicated quality improvement techniques. We have also recently developed the REPS, a tool that predicts postoperative rNMB.\n\nThis is a retrospective, observational, cohort study based on on-file hospital data from Beth Israel Deaconess Medical Center, Boston, Massachusetts.\n\nThe primary aim is to validate the dichotomized REPS (high-risk versus low-risk for rNMB which corresponds to a REPS \\>4 and \\<4, respectively) for the outcome of postoperative respiratory complications with BIDMC data. The investigators will utilize the pre-defined variables identified to predict residual neuromuscular blockade (REPS) at BIDMC.\n\nThe secondary aim is to compare the predictive values of the dichotomized REPS with dichotomized train-of-four (TOF)-ratio (low TOF-ratio versus high TOF ratio which corresponds to a TOF-ratio \\<0.9 and \\>=0.9, respectively) for respiratory complications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients who underwent non-cardiac surgery under general anesthesia with intermediate-acting NMBAs and are admitted to the Post-Anaesthesia Care Unit (PACU) after surgery.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years or older\n* Non-cardiac surgery\n* General anesthesia with intermediate-acting NMBAs (atracurium, cisatracurium, vecuronium, or rocuronium)\n* Extubated in the operating room\n* PACU after surgery\n\nExclusion Criteria:\n\n* American Society of Anesthesiology (ASA) Physical Status Classification of 5 or 6\n* Did not receive neuromuscular blocking agents\n* Missing last covariates'}, 'identificationModule': {'nctId': 'NCT03585400', 'briefTitle': 'Validation of the REPS Prediction Tool', 'organization': {'class': 'OTHER', 'fullName': 'Beth Israel Deaconess Medical Center'}, 'officialTitle': 'Validation of the REPS Prediction Tool to Improve Quality of Perioperative Care', 'orgStudyIdInfo': {'id': '2018P000264'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Observational Study', 'description': 'Observational Study: Not Applicable for Observational Studies', 'interventionNames': ['Other: Observational Study']}], 'interventions': [{'name': 'Observational Study', 'type': 'OTHER', 'description': 'Observational Study: Not Applicable for Observational Studies', 'armGroupLabels': ['Observational Study']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Matthias Eikermann, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beth Israel Deaconess Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beth Israel Deaconess Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Anaesthesia', 'investigatorFullName': 'Matthias Eikermann', 'investigatorAffiliation': 'Beth Israel Deaconess Medical Center'}}}}