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Validation of the REPS Prediction Tool

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03585400
Enrollment
101510
Registered
2018-07-13
Start date
2018-06-29
Completion date
2020-12-31
Last updated
2021-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

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.

Interventions

OTHERObservational Study

Observational Study: Not Applicable for Observational Studies

Sponsors

Beth Israel Deaconess Medical Center
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Postoperative Respiratory Complications (PRC)After extubation, up to 7 days after surgeryPRC composite of invasive mechanical ventilation requirement within 7 postoperative days or immediate post-extubation desaturation (SpO2 \<90%) within 10 minutes.

Other

MeasureTime frameDescription
Hospital ReadmissionUp to 30 days after dischargeHospital readmission defined as any admission to BIDMC.
Hospital Length of StayDuring hospital stay, on average 4 days, and no longer than 1 yearHospital length of stay defined as the number of days elapsed from hospital admission to hospital discharge.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026