ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 35 of 396 for:    Neuromuscular | Recruiting, Not yet recruiting, Available Studies | "Muscular Diseases"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01933841
Recruitment Status : Recruiting
First Posted : September 2, 2013
Last Update Posted : July 11, 2017
Sponsor:
Information provided by (Responsible Party):
Edward Sherwood, Vanderbilt University Medical Center

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.


Condition or disease Intervention/treatment
Muscle Weakness Device: TOF-Watch SX Procedure: Notify the provider

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 : Observational
Estimated Enrollment : 400 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: The Impact of Quantitative Neuromuscular Monitoring in the PACU on Residual Blockade and Postoperative Recovery
Study Start Date : August 2013
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018

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.
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.
Other Name: Acceleromyographic monitoring

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.

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
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 Name: Acceleromyographic monitoring

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.

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
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 Name: Acceleromyographic monitoring

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.

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
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 Name: Acceleromyographic monitoring

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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. Decrease in incidence of perioperative pneumonia [ Time Frame: 28 days 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 long-term postoperative complications.

  5. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients who receive an intraoperative neuromuscular blockade
Criteria

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

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): NCT01933841


Contacts
Contact: Edward Sherwood, M.D. 615-322-2564 edward.r.sherwood@Vanderbilt.Edu
Contact: Jennifer Morse, M.S. 615-936-8495 jennifer.morse@vanderbilt.edu

Locations
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Edward Sherwood, M.D.    615-322-2564    edward.r.sherwood@Vanderbilt.Edu   
Principal Investigator: Edward Sherwood, M.D.         
Sponsors and Collaborators
Vanderbilt University Medical Center
Investigators
Principal Investigator: Edward R Sherwood, M.D. Vanderbilt University Medical Center

Responsible Party: Edward Sherwood, Professor, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT01933841     History of Changes
Other Study ID Numbers: 131282
First Posted: September 2, 2013    Key Record Dates
Last Update Posted: July 11, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Edward Sherwood, Vanderbilt University Medical Center:
Post operative residual curarization
Neuromuscular blocking drugs

Additional relevant MeSH terms:
Muscle Weakness
Paresis
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathologic Processes
Signs and Symptoms