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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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Acceleromyography (AMG) is the most wide spread used method to assess neuromuscular block during anesthesia. However AMG is known to be inaccurate when compared to the gold standard in neuromuscular transmission monitoring, electromyography (EMG). Furthermore when the patients arms require to be positioned next to the body and beneath surgical drapes, AMG measurements are often hindered and inaccurate. The TOF cuff is a new device which measures neuromuscular blockade at the upper arm with a blood pressure cuff. It overcomes the previously mentioned disadvantages of AMG. However, it validity compared to EMG and AMG has not yet fully been investigated.
This study aims to compare the bias, limits of agreement and precision of the Train-of-Four cuff relative to AMG and EMG during recovery of moderate and deep neuromuscular block in patients with normal body mass index and morbidly obese patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| moderate neuromuscular block, normal body mass index | Patients with normal BMI (< 30) who will receive a moderate neuromuscular block (train of four 1-3 twitches) |
| |
| deep neuromuscular block, normal body mass index | Patients with normal BMI (< 30) who will receive a deep neuromuscular block (post tetanic count of 1-2 twitches) |
| |
| moderate neuromuscular block, high body mass index | Patients with high BMI (> 30) who will receive a moderate neuromuscular block (train of four 1-3 twitches) |
| |
| deep neuromuscular block, high body mass index | Patients with high BMI (> 30) who will receive a deep neuromuscular block (post tetanic count of 1-2 twitches) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Measurements of the level of neuromuscular blockade | Diagnostic Test | Study participant were not prospectively exposed to an intervention. Administration of a moderate or deep neuromuscular blockade is at the discretion of the attending anesthesiologist. Study participants only received diagnostic non-invasive monitoring. In routine clinical care the neuromuscular blockade is monitored non-invasively by either acceleromyography, electromyography or by the TOF-Cuff. In this study participants were monitored by the monitors and were not exposed to any additional risk and no effect of an intervention was assessed in this study. |
| Measure | Description | Time Frame |
|---|---|---|
| Depth of Neuromuscular Block During Moderate Neuromuscular Blockade (Outcome Measure/Row Title Train of Four Ratio) and During Deep Neuromuscular Blockade (Outcome Measure/ Row Title Post Tetanic Count) | Depth of as neuromuscular block will be compared between the Tof-Cuff and electromography at five minute intervals during moderate neuromuscular blockade. Bland-Altman analysis modified for repeated measurements (http://sec.lumc.nl/method\_agreement\_analysis). This Bland-Altman analysis corrects for between subject variability of repeated paired measurements in individual subjects. Bland-Altman analysis estimates bias and limits of agreement (95% differences between compared devices) between Tof-Cuff and electromography and evaluates instrumental imprecision by calculating the repeatability coefficient, which is equal to the standard deviation of the within-subject variability of each device. For interpretation of the Bland-Altman bias during offset of neuromuscular blockade one can assume that a bias above zero indicates that TOF-Cuff overestimates neuromuscular blockade recovery whilst a bias below zero indicates that Tof-Cuff underestimates neuromuscular blockade recovery. | at 5 minute intervals during the length of the entire procedure [which lasted between 20 to 372 minutes]; a mean of the differences between the TOF-Cuff and electromyography of all measurements is calculated and reported below |
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Inclusion Criteria:
Exclusion Criteria:
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American society of Anesthesiologist Physical Status class I-III patients >18 years of age BMI either < 30 or > 30 kg/m2
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| Name | Affiliation | Role |
|---|---|---|
| Albert Dahan, MD PhD | Leiden University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Leiden University Medical Center | Leiden | South Holland | Netherlands | |||
| Medisch Centrum Haaglanden / Nederlandse Obesitas Kliniek |
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| ID | Title | Description |
|---|---|---|
| FG000 | Moderate Neuromuscular Block, Normal Body Mass Index | Patients with normal normal body mass index(< 30) who will receive a moderate neuromuscular block (train of four 1-3 twitches) as determined by the attending anesthesiologist. The TOF-Cuff was compared with electromyography |
| FG001 | Deep Neuromuscular Block, Normal Body Mass Index | Patients with normal normal body mass index(< 30) who will receive a deep neuromuscular block (post tetanic count of 1-2 twitches) as determined by the attending anesthesiologist. The TOF-Cuff was compared with electromyography |
| FG002 | Moderate Neuromuscular Block, High Body Mass Index | Patients with high normal body mass index(> 30) who will receive a moderate neuromuscular block (train of four 1-3 twitches) as determined by the attending anesthesiologist. The TOF-Cuff was compared with electromyography |
| FG003 | Deep Neuromuscular Block, High Body Mass Index | Patients with high normal body mass index(> 30) who will receive a deep neuromuscular block (post tetanic count of 1-2 twitches) as determined by the attending anesthesiologist. The TOF-Cuff was compared with electromyography |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Depth of neuromuscular blockade varied in this observational study. In the Leiden University Medical Centre 148 patients received a moderate neuromuscular blockade whilst 52 received a deep neuromuscular blockade; total 200 patients. In the Dutch Obesity Clinic 21 patients received a moderate neuromuscular blockade whilst 29 received a deep neuromuscular blockade; total 50 patients.
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| ID | Title | Description |
|---|---|---|
| BG000 | Moderate Neuromuscular Block, Normal Body Mass Index | Patients recruited in the Leiden University Medical Centre with a normal body mass index (18-30) Train of four ratios are collected during moderate neuromuscular blockade. |
| BG001 | Deep Neuromuscular Block, Normal Body Mass Index |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age in years, see below |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Depth of Neuromuscular Block During Moderate Neuromuscular Blockade (Outcome Measure/Row Title Train of Four Ratio) and During Deep Neuromuscular Blockade (Outcome Measure/ Row Title Post Tetanic Count) | Depth of as neuromuscular block will be compared between the Tof-Cuff and electromography at five minute intervals during moderate neuromuscular blockade. Bland-Altman analysis modified for repeated measurements (http://sec.lumc.nl/method\_agreement\_analysis). This Bland-Altman analysis corrects for between subject variability of repeated paired measurements in individual subjects. Bland-Altman analysis estimates bias and limits of agreement (95% differences between compared devices) between Tof-Cuff and electromography and evaluates instrumental imprecision by calculating the repeatability coefficient, which is equal to the standard deviation of the within-subject variability of each device. For interpretation of the Bland-Altman bias during offset of neuromuscular blockade one can assume that a bias above zero indicates that TOF-Cuff overestimates neuromuscular blockade recovery whilst a bias below zero indicates that Tof-Cuff underestimates neuromuscular blockade recovery. | The outcome measurement data indicates the difference between both devices (TOF-Cuff versus electromography) of either train of four measurements or post tetanic count measurements . Bias is a unitless number and therefore the number option is chosen as measurement type. It is neither a ratio, median or mean. The bias is zero when there is no difference between measurements. | Posted | Number | 95% Confidence Interval | bias |
One month postoperative collection of (serious) adverse event conform the definition of clinicaltrials.gov
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Moderate Neuromuscular Block, Normal Body Mass Index | Patients recruited in the Leiden University Medical Centre with a normal body mass index (18-30) Train of four ratios are collected during moderate neuromuscular blockade. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Postoperative prolonged hospital admission | Injury, poisoning and procedural complications | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Postoperative procedural complications | Injury, poisoning and procedural complications | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Maarten Honing | LUMC | +31715264038 | g.h.m.honing@lumc.nl |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 19, 2019 | Jul 21, 2021 | Prot_SAP_000.pdf |
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|
| The Hague |
| South Holland |
| Netherlands |
Patients recruited in the Leiden University Medical Centre with a normal body mass index (18-30) Post tetanic counts are collected during deep neuromuscular blockade |
| BG002 | Moderate Neuromuscular Block, High Body Mass Index | Measurements during deep neuromuscular block in Patients recruited in the Dutch Obesity Clinic with a high body mass index (>30) Train of four ratios are collected during moderate neuromuscular blockade. |
| BG003 | Deep Neuromuscular Block, High Body Mass Index | Measurements during deep neuromuscular block in Patients recruited in the Dutch Obesity Clinic with a high body mass index (>30) Post tetanic counts are collected during deep neuromuscular blockade |
| BG004 | Total | Total of all reporting groups |
| Full Range |
| years |
|
| Sex: Female, Male | Sex: either male or female | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Count of participants | Count of Participants | Participants |
|
| at 5 minute intervals during the length of the entire procedure [which lasted between 20 to 372 minutes]; a mean of the differences between the TOF-Cuff and electromyography of all measurements is calculated and reported below |
|
|
|
|
| 0 |
| 148 |
| 7 |
| 148 |
| 13 |
| 148 |
| EG001 | Deep Neuromuscular Block, Normal Body Mass Index | Patients recruited in the Leiden University Medical Centre with a normal body mass index (18-30) Post tetanic counts are collected during deep neuromuscular blockade | 0 | 52 | 3 | 52 | 7 | 52 |
| EG002 | Moderate Neuromuscular Block, High Body Mass Index | Measurements during deep neuromuscular block in Patients recruited in the Dutch Obesity Clinic with a high body mass index (>30) Train of four ratios are collected during moderate neuromuscular blockade. | 0 | 21 | 0 | 21 | 0 | 21 |
| EG003 | Deep Neuromuscular Block, High Body Mass Index | Measurements during deep neuromuscular block in Patients recruited in the Dutch Obesity Clinic with a high body mass index (>30) Post tetanic counts are collected during deep neuromuscular blockade | 0 | 29 | 0 | 29 | 0 | 29 |
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| Male |
|
| Title | Measurements |
|---|---|
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