- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01933841
The Impact of Quantitative Neuromuscular Monitoring in the PACU on Residual Blockade and Postoperative Recovery
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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. Physiological data suggest that PORC impairs normal respiratory function, and compelling evidence suggests PORC impairs clinical recovery in the immediate postoperative period and prolongs PACU length of stay. However, despite the widespread use of NMBDs and the frequent occurrence of PORC, limitations in the literature prevent an understanding of their full impact on clinical outcomes. This study will collect data about patients who receive NMBDs and examine the impact of monitoring on incidences of PORC.
The incidence of PORC and postoperative complications after the introduction of monitoring in the PACU will be determined by measuring TOF ratios and tracking the postoperative outcomes in the surgical patients over time.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Tennessee
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Nashville, Tennessee, United States, 37232
- Vanderbilt University Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
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.
Other Names:
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 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.
|
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.
Other Names:
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 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.
|
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.
Other Names:
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 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.
|
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.
Other Names:
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Decrease in incidence of postoperative residual curarization
Time Frame: 10 minute after arrival to PACU
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Decrease in the incidence of hemoglobin desaturation
Time Frame: PACU stay (Typically 1-2 hours post-operatively)
|
This aim is part of a group of aims which will test the hypothesis that initiation of the routine TOF monitoring program will decrease short-term postoperative complications.
|
PACU stay (Typically 1-2 hours post-operatively)
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Decrease in need for reintubation
Time Frame: 24 hours after PACU entry
|
This aim is part of a group of aims which will test the hypothesis that initiation of the routine TOF monitoring program will decrease short-term postoperative complications.
|
24 hours after PACU entry
|
Decrease in length of stay in the PACU
Time Frame: PACU stay (Typically 1-2 hours post-operatively)
|
This aim is part of a group of aims which will test the hypothesis that initiation of the routine TOF monitoring program will decrease short-term postoperative complications.
|
PACU stay (Typically 1-2 hours post-operatively)
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Decrease in incidence of perioperative pneumonia
Time Frame: 28 days post-operatively
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This aim is part of a group of aims which will test the hypothesis that initiation of the routine TOF monitoring program will decrease long-term postoperative complications.
|
28 days post-operatively
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Decrease in time to readiness for discharge
Time Frame: Hospital stay (Expected average of 3 days)
|
This aim is part of a group of aims which will test the hypothesis that initiation of the routine TOF monitoring program will decrease long-term postoperative complications.
|
Hospital stay (Expected average of 3 days)
|
Collaborators and Investigators
Investigators
- Principal Investigator: Edward R Sherwood, M.D., Vanderbilt University Medical Center
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 131282
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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