Validation of the REPS Prediction Tool

Residual Neuromuscular Blockade Clinical Trial

Official title:

Validation of the REPS Prediction Tool to Improve Quality of Perioperative Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03585400
• Other study ID #: 2018P000264
• Status: Completed
• Start date: June 29, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: January 2021
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101510
• Est. completion date: December 31, 2020
• Est. primary completion date: December 10, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Curarization, Postoperative Residual
• Delayed Emergence from Anesthesia
• Postoperative Respiratory Complication
• Residual Neuromuscular Blockade

Intervention

Other:
• Observational Study
Observational Study: Not Applicable for Observational Studies

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View 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:CD012763. doi: 10.1002/14651858.CD012763. Review. — View Citation

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

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Hospital Readmission	Hospital readmission defined as any admission to BIDMC.	Up to 30 days after discharge
Other	Hospital Length of Stay	Hospital length of stay defined as the number of days elapsed from hospital admission to hospital discharge.	During hospital stay, on average 4 days, and no longer than 1 year
Primary	Postoperative Respiratory Complications (PRC)	PRC composite of invasive mechanical ventilation requirement within 7 postoperative days or immediate post-extubation desaturation (SpO2 <90%) within 10 minutes.	After extubation, up to 7 days after surgery