The Impact of Quantitative Neuromuscular Monitoring in the PACU on Residual Blockade and Postoperative Recovery

NCT01933841 | Completed DMC

• 1 other identifier: 131282
• Study Type: observational
• Target: 201
• Locations: 1 country
• Sites: 1

Brief Summary

Neuromuscular blocking drugs (NMBDs) provide anesthesiologists with powerful intraoperative tools, but their use carries the potential risk of serious postoperative complications. NMBD-induced muscle weakness that lingers into the postoperative period, known as postoperative residual curarization (PORC), is present in as many as 40% of all patients that receive neuromuscular blocking agents. The Post Anesthesia Care Unit will be introducing monitoring as part of standard of care. This study will collect data about patients who receive NMBDs and examine the impact of monitoring on incidences of PORC. Our study is designed to test the following hypotheses: Hypothesis 1: The initiation of quantitative TOF monitoring as part of the standard PACU entry evaluation will change practitioner behavior in a manner that decreases the incidence of PORC in surgical patients at VUMC. Hypothesis 2: The initiation of the routine TOF monitoring program will decrease the incidence of short- and long-term postoperative complications at VUMC.

Conditions

Muscle Weakness

Keywords

Post operative residual curarization; Neuromuscular blocking drugs

Outcome Measures

Primary Outcomes (1)

• Decrease in incidence of postoperative residual curarization

  This aim will test the hypothesis that initiation of quantitative Train-Of-Four monitoring as part of the standard PACU entry evaluation will change practitioner behavior in a manner that decreases the incidence of PORC in surgical patients at Vanderbilt University Medical Center. Quantitative TOF monitoring will be introduced as a standard component of the PACU entry evaluation for all patients that receive NMBDs as part of their care. It is expected that the proportion of patients with TOF \< 0.9 will decrease over time after initiation of the routine monitoring system.

  10 minute after arrival to PACU

Secondary Outcomes (5)

• Decrease in the incidence of hemoglobin desaturation

  PACU stay (Typically 1-2 hours post-operatively)

• Decrease in need for reintubation

  24 hours after PACU entry

• Decrease in length of stay in the PACU

  PACU stay (Typically 1-2 hours post-operatively)

• Decrease in incidence of perioperative pneumonia

  28 days post-operatively

• Decrease in time to readiness for discharge

  Hospital stay (Expected average of 3 days)

Study Arms (4)

Days 1-30

Adult surgery patients whose operations occurred during Days 1-30 after monitoring is introduced in the PACU. Patients will have their TOF ratio measured and recorded using a TOF-Watch SX. The nurse will monitor the patient and notify the provider of the patient's TOF-ratio if appropriate.

Device: TOF-Watch SX; Procedure: Notify the provider

Days 31-60

Adult surgery patients whose operations occurred during Days 31-60 after monitoring is introduced in the PACU. Patients will have their TOF ratio measured and recorded using a TOF-Watch SX. The nurse will monitor the patient and notify the provider of the patient's TOF-ratio if appropriate.

Device: TOF-Watch SX; Procedure: Notify the provider

Days 61-90

Adult surgery patients whose operations occurred during Days 61-90 after monitoring is introduced in the PACU. Patients will have their TOF ratio measured and recorded using a TOF-Watch SX. The nurse will monitor the patient and notify the provider of the patient's TOF-ratio if appropriate.

Device: TOF-Watch SX; Procedure: Notify the provider

Days 91-120

Adult surgery patients whose operations occurred during Days 91-120 after monitoring is introduced in the PACU. Patients will have their TOF ratio measured and recorded using a TOF-Watch SX. The nurse will monitor the patient and notify the provider of the patient's TOF-ratio if appropriate.

Device: TOF-Watch SX; Procedure: Notify the provider

Interventions

TOF-Watch SX DEVICE

As part of standard care, patients who undergo intraoperative neuromuscular blockade will have their TOF ratio measured and recorded during their first 10 minutes in the PACU by perioperative nursing staff.

Also known as: Acceleromyographic monitoring

Days 1-30; Days 31-60; Days 61-90; Days 91-120

Notify the provider PROCEDURE

Based on the TOF reading, the patient's PACU nurse will page the provider who administered the block and/or a designated "Reversal Support" team member. The page will identify the patient and notify the provider of the suboptimal TOF ratio.

Days 1-30; Days 31-60; Days 61-90; Days 91-120

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients who receive an intraoperative neuromuscular blockade

You may qualify if:

• Surgical patients \> 18 years of age
• Received one or more NMBDs during surgery
• Surgery took place during the first 120 days following the introduction of TOF monitoring in the PACU

You may not qualify if:

• Surgical patients \< 18 years of age
• Received no NMBDs during surgery
• Transfer from the OR to the PACU was delayed (by high PACU volume, for example)
• Had a procedure or has a preexisting condition that prevents accurate monitoring

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Muscle Weakness

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Edward R Sherwood, M.D.

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 23, 2013
• First Posted: September 2, 2013
• Study Start: August 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: September 4, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)