Muscle WeaknessNCT01933841
The Impact of Quantitative Neuromuscular Monitoring in the PACU on Residual Blockade and Postoperative Recovery
An observational study of Muscle Weakness, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
Neuromuscular blocking drugs (NMBDs) provide anesthesiologists with powerful intraoperative tools, but their use carries the potential risk of serious postoperative complications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Muscle Weakness
- What is being tested?
- TOF-Watch SX and Notify the provider
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 201 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to Jul 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients who receive an intraoperative neuromuscular blockade
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
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:
Read more
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.
Read the 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.
- Conditions
- Muscle Weakness
- Being tested
- TOF-Watch SX, Notify the provider
- Keywords
- Post operative residual curarization, Neuromuscular blocking drugs
- Medical subject headings
- Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TOF-Watch SXDevice
Also called Acceleromyographic monitoring
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.
Notify the providerProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Device: TOF-Watch SX; Procedure: Notify the provider |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 minute after arrival to PACU
Secondary outcomes (5)
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.
Measured: PACU stay (Typically 1-2 hours post-operatively)
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.
Measured: 24 hours after PACU entry
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.
Measured: PACU stay (Typically 1-2 hours post-operatively)
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.
Measured: 28 days post-operatively
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.
Measured: Hospital stay (Expected average of 3 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2013 (estimated)
- Study startAug 2016
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle WeaknessStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edward Sherwood, Vanderbilt University Medical Center
- Investigators
- Edward R Sherwood, M.D., Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01933841
- Sponsor's protocol ID
- 131282
- Status last verified
- Sep 2019
- First submitted
- 23 Aug 2013
- Last updated
- 4 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Quantitative Neuromuscular Monitoring in the PACU on Residual Blockade and Postoperative Recovery
- ClinicalTrials.gov ID
- NCT01933841
- Acronym / sponsor ID
- 131282
- Conditions
- Muscle Weakness
- Keywords
- Post operative residual curarization, Neuromuscular blocking drugs
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 2 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Days 1-30 | – | Device: TOF-Watch SX, Procedure: Notify the providerAdult 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. |
| Days 31-60 | – | Device: TOF-Watch SX, Procedure: Notify the providerAdult 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. |
| Days 61-90 | – | Device: TOF-Watch SX, Procedure: Notify the providerAdult 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. |
| Days 91-120 | – | Device: TOF-Watch SX, Procedure: Notify the providerAdult 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients who receive an intraoperative neuromuscular blockade
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TOF-Watch SXAlso: Acceleromyographic monitoringAs 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. | Device | Days 1-30, Days 31-60, Days 61-90, Days 91-120 |
| Notify the providerBased 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. | Procedure or surgery | Days 1-30, Days 31-60, Days 61-90, Days 91-120 |
Primary outcome
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.
5 secondary outcomes
Decrease in the incidence of hemoglobin desaturation
Time frame: PACU stay (Typically 1-2 hours post-operatively)
Decrease in need for reintubation
Time frame: 24 hours after PACU entry
Decrease in length of stay in the PACU
Time frame: PACU stay (Typically 1-2 hours post-operatively)
Decrease in incidence of perioperative pneumonia
Time frame: 28 days post-operatively
Decrease in time to readiness for discharge
Time frame: Hospital stay (Expected average of 3 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward R Sherwood, M.D. principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Muscle Weakness, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease in incidence of postoperative residual curarization (time frame: 10 minute after arrival to PACU). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2019.