Validation of the REPS Prediction Tool

January 25, 2021 updated by: Matthias Eikermann, Beth Israel Deaconess Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

101510

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
After extubation, up to 7 days after surgery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital Readmission
Time Frame: Up to 30 days after discharge
Hospital readmission defined as any admission to BIDMC.
Up to 30 days after discharge
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.
During hospital stay, on average 4 days, and no longer than 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beth Israel Deaconess Medical Center

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 29, 2018

Primary Completion (ACTUAL)

December 10, 2019

Study Completion (ACTUAL)

December 31, 2020

Study Registration Dates

First Submitted

June 29, 2018

First Submitted That Met QC Criteria

July 11, 2018

First Posted (ACTUAL)

July 13, 2018

Study Record Updates

Last Update Posted (ACTUAL)

January 26, 2021

Last Update Submitted That Met QC Criteria

January 25, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018P000264

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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