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

Muscle Weakness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01933841
• Other study ID #: 131282
• Status: Completed
• Start date: August 2016
• Est. completion date: July 2017

Study information

• Verified date: September 2019
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 201
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Muscle Weakness

Intervention

Device:
• TOF-Watch SX
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.

Procedure:
• Notify the provider
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.

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Decrease in the incidence of hemoglobin desaturation	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)
Secondary	Decrease in need for reintubation	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
Secondary	Decrease in length of stay in the PACU	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)
Secondary	Decrease in incidence of perioperative pneumonia	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
Secondary	Decrease in time to readiness for discharge	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)