Validation of the REPS Prediction Tool

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ClinicalTrials.gov Identifier: NCT03585400

Recruitment Status : Completed

First Posted : July 13, 2018

Last Update Posted : January 26, 2021

Sponsor:

Information provided by (Responsible Party):

Matthias Eikermann, Beth Israel Deaconess Medical Center

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment
Residual Neuromuscular Blockade Curarization, Postoperative Residual Postoperative Respiratory Complication	Other: Observational Study

Detailed Description:

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.

This is a retrospective, observational, cohort study based on on-file hospital data from Beth Israel Deaconess Medical Center, Boston, Massachusetts.

The 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.

The 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.

Study Design

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Study Type :	Observational
Actual Enrollment :	101510 participants
Observational Model:	Other
Time Perspective:	Retrospective
Official Title:	Validation of the REPS Prediction Tool to Improve Quality of Perioperative Care
Actual Study Start Date :	June 29, 2018
Actual Primary Completion Date :	December 10, 2019
Actual Study Completion Date :	December 31, 2020

Groups and Cohorts

Group/Cohort	Intervention/treatment
Observational Study Observational Study: Not Applicable for Observational Studies	Other: Observational Study Observational Study: Not Applicable for Observational Studies

Outcome Measures

Primary Outcome Measures :

Postoperative Respiratory Complications (PRC) [ Time Frame: After extubation, up to 7 days after surgery ]
PRC composite of invasive mechanical ventilation requirement within 7 postoperative days or immediate post-extubation desaturation (SpO2 <90%) within 10 minutes.

Other Outcome Measures:

Hospital Readmission [ Time Frame: Up to 30 days after discharge ]
Hospital readmission defined as any admission to BIDMC.
Hospital Length of Stay [ Time Frame: During hospital stay, on average 4 days, and no longer than 1 year ]
Hospital length of stay defined as the number of days elapsed from hospital admission to hospital discharge.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

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.

Criteria

Inclusion Criteria:

18 years or older
Non-cardiac surgery
General anesthesia with intermediate-acting NMBAs (atracurium, cisatracurium, vecuronium, or rocuronium)
Extubated in the operating room
PACU after surgery

Exclusion Criteria:

American Society of Anesthesiology (ASA) Physical Status Classification of 5 or 6
Did not receive neuromuscular blocking agents
Missing last covariates

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03585400

Locations

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United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215

Sponsors and Collaborators

Beth Israel Deaconess Medical Center

Investigators

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Principal Investigator:	Matthias Eikermann, MD, PhD	Beth Israel Deaconess Medical Center

More Information

Publications:

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:CD012763. doi: 10.1002/14651858.CD012763. Review.

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.

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.

Intercontinental Marketing Services (IMS) Health, Multinational Integrated Data Analysis System (MIDAS), September 2010

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.

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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Patrocínio 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.

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Responsible Party:	Matthias Eikermann, Professor of Anaesthesia, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:	NCT03585400
Other Study ID Numbers:	2018P000264
First Posted:	July 13, 2018 Key Record Dates
Last Update Posted:	January 26, 2021
Last Verified:	January 2021

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Matthias Eikermann, Beth Israel Deaconess Medical Center:


Neuromuscular Blockade Agents Neuromuscular Blockade Reversal Perioperative Care Quality Improvement Respiratory Complication

Additional relevant MeSH terms:

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Delayed Emergence from Anesthesia Postoperative Complications Pathologic Processes

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