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Validation of the REPS Prediction Tool

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ClinicalTrials.gov Identifier: NCT03585400
Recruitment Status : Active, not recruiting
First Posted : July 13, 2018
Last Update Posted : January 18, 2020
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 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.

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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
Estimated Study Completion Date : June 2020

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

  2. 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)
  • 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

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

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    
Other Study ID Numbers: 2018P000264
First Posted: July 13, 2018    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020

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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