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Validation of the REPS Prediction Tool

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ClinicalTrials.gov Identifier: NCT03585400
Recruitment Status : Recruiting
First Posted : July 13, 2018
Last Update Posted : January 16, 2019
Sponsor:
Information provided by (Responsible Party):
Matthias Eikermann, Beth Israel Deaconess Medical Center

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 validate this prediction tool using Beth Israel Deaconess Medical Center/BIDMC's data.

Condition or disease Intervention/treatment
Residual Neuromuscular Blockade Curarization, Postoperative Residual 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 REPS with BIDMC data. The investigators will utilize the pre-defined variables identified to predict residual neuromuscular blockade at BIDMC.

A dichotomized REPS (high-risk versus low-risk for rNMB which corresponds to a REPS >4 and <4, respectively) will be validated for clinical outcomes, such as postoperative respiratory complications, 30-day hospital readmission and hospital length of stay.


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Study Type : Observational
Estimated Enrollment : 100000 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
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

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




Primary Outcome Measures :
  1. rNMB [ Time Frame: During surgery, maximum of 24 hours ]
    rNMB will be used to compare the REPS to the last TOF ratio documented.


Other Outcome Measures:
  1. Respiratory Complications [ Time Frame: Up to 7 days after surgery ]
    Respiratory complications defined as pneumonia, respiratory failure, pulmonary edema, or reintubation.

  2. Hospital Readmission [ Time Frame: Up to 30 days after discharge ]
    Hospital readmission defined as any admission to BIDMC.

  3. 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.



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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)
  • PACU after surgery

Exclusion Criteria:

  • American Society of Anesthesiology (ASA) Physical Status Classification of 5 or 6
  • Missing last covariates

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


Contacts
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Contact: Matthias Eikermann, MD, PhD (617) 726-3030 meikerma@bidmc.harvard.edu
Contact: Maria Patrocinio, MD msilvadi@bidmc.harvard.edu

Locations
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United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Matthias Eikermann, MD, PDhD    617-726-3030    meikerma@bidmc.harvard.edu   
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
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Principal Investigator: Matthias Eikermann, MD, PhD Beth Israel Deaconess Medical Center

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

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Responsible Party: Matthias Eikermann, Professor of Anaesthesia, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT03585400     History of Changes
Other Study ID Numbers: 2018P000264
First Posted: July 13, 2018    Key Record Dates
Last Update Posted: January 16, 2019
Last Verified: January 2019

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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

Additional relevant MeSH terms:
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Delayed Emergence from Anesthesia
Postoperative Complications
Pathologic Processes