Validation of the REPS Prediction Tool

NCT03585400 | Completed

• 1 other identifier: 2018P000264
• Study Type: observational
• Target: 101,510
• Locations: 1 country
• Sites: 1

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.

Conditions

Residual Neuromuscular Blockade; Curarization, Postoperative Residual; Postoperative Respiratory Complication

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Other Outcomes (2)

• Hospital Readmission

  Up to 30 days after discharge

• Hospital Length of Stay

  During hospital stay, on average 4 days, and no longer than 1 year

Study Arms (1)

Observational Study

Observational Study: Not Applicable for Observational Studies

Other: Observational Study

Interventions

Observational Study OTHER

Observational Study: Not Applicable for Observational Studies

Observational Study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Related Publications (8)

• 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: 28806470 BACKGROUND

• 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: 25935840 BACKGROUND

• 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.

  PMID: 23757472 BACKGROUND

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

  BACKGROUND

• 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: 25919486 BACKGROUND

• 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: 29974459 BACKGROUND

• 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: 30020144 BACKGROUND

• 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.

  PMID: 33497061 DERIVED

MeSH Terms

Conditions

Delayed Emergence from Anesthesia

Interventions

Observation

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Matthias Eikermann, MD, PhD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anaesthesia

Study Record Dates

• First Submitted: June 29, 2018
• First Posted: July 13, 2018
• Study Start: June 29, 2018
• Primary Completion: December 10, 2019
• Study Completion: December 31, 2020
• Last Updated: January 26, 2021

Record last verified: 2021-01

Locations

US (1)