Trial Outcomes & Findings for Evaluation of the Tof Cuff for Perioperative Neuromuscular Transmission (NCT NCT03117387)
NCT ID: NCT03117387
Last Updated: 2024-03-25
Results Overview
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.
COMPLETED
250 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
2024-03-25
Participant Flow
Participant milestones
| Measure |
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
|
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
|
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
|
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
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
126
|
74
|
43
|
7
|
|
Overall Study
COMPLETED
|
126
|
74
|
43
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Moderate Neuromuscular Block, Normal Body Mass Index
n=148 Participants
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.
|
Deep Neuromuscular Block, Normal Body Mass Index
n=52 Participants
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
|
Moderate Neuromuscular Block, High Body Mass Index
n=21 Participants
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.
|
Deep Neuromuscular Block, High Body Mass Index
n=29 Participants
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
|
Total
n=250 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
57 years
n=148 Participants
|
51 years
n=52 Participants
|
45 years
n=21 Participants
|
47 years
n=29 Participants
|
55 years
n=250 Participants
|
|
Sex: Female, Male
Female
|
86 Participants
n=148 Participants
|
25 Participants
n=52 Participants
|
12 Participants
n=21 Participants
|
23 Participants
n=29 Participants
|
146 Participants
n=250 Participants
|
|
Sex: Female, Male
Male
|
62 Participants
n=148 Participants
|
27 Participants
n=52 Participants
|
9 Participants
n=21 Participants
|
6 Participants
n=29 Participants
|
104 Participants
n=250 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Count of participants
|
148 Participants
n=148 Participants
|
52 Participants
n=52 Participants
|
21 Participants
n=21 Participants
|
29 Participants
n=29 Participants
|
250 Participants
n=250 Participants
|
PRIMARY outcome
Timeframe: 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 belowPopulation: 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.
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.
Outcome measures
| Measure |
Moderate Neuromuscular Block, Normal Body Mass Index
n=148 Participants
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.
|
Deep Neuromuscular Block, Normal Body Mass Index
n=52 Participants
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
|
Moderate Neuromuscular Block, High Body Mass Index
n=21 Participants
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.
|
Deep Neuromuscular Block, High Body Mass Index
n=29 Participants
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
|
|---|---|---|---|---|
|
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)
"train-of-four ratio"
|
0.312 bias
Interval 0.287 to 0.338
|
—
|
0.384 bias
Interval 0.299 to 0.469
|
—
|
|
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)
"post-tetanic-count"
|
—
|
3.405 bias
Interval 2.294 to 4.517
|
—
|
-0.17 bias
Interval -2.872 to 2.531
|
Adverse Events
Moderate Neuromuscular Block, Normal Body Mass Index
Deep Neuromuscular Block, Normal Body Mass Index
Moderate Neuromuscular Block, High Body Mass Index
Deep Neuromuscular Block, High Body Mass Index
Serious adverse events
| Measure |
Moderate Neuromuscular Block, Normal Body Mass Index
n=148 participants at risk
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.
|
Deep Neuromuscular Block, Normal Body Mass Index
n=52 participants at risk
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
|
Moderate Neuromuscular Block, High Body Mass Index
n=21 participants at risk
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.
|
Deep Neuromuscular Block, High Body Mass Index
n=29 participants at risk
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
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Postoperative prolonged hospital admission
|
4.7%
7/148 • Number of events 7 • One month postoperative collection of (serious) adverse event conform the definition of clinicaltrials.gov
|
5.8%
3/52 • Number of events 3 • One month postoperative collection of (serious) adverse event conform the definition of clinicaltrials.gov
|
0.00%
0/21 • One month postoperative collection of (serious) adverse event conform the definition of clinicaltrials.gov
|
0.00%
0/29 • One month postoperative collection of (serious) adverse event conform the definition of clinicaltrials.gov
|
Other adverse events
| Measure |
Moderate Neuromuscular Block, Normal Body Mass Index
n=148 participants at risk
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.
|
Deep Neuromuscular Block, Normal Body Mass Index
n=52 participants at risk
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
|
Moderate Neuromuscular Block, High Body Mass Index
n=21 participants at risk
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.
|
Deep Neuromuscular Block, High Body Mass Index
n=29 participants at risk
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
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Postoperative procedural complications
|
8.8%
13/148 • Number of events 13 • One month postoperative collection of (serious) adverse event conform the definition of clinicaltrials.gov
|
13.5%
7/52 • Number of events 7 • One month postoperative collection of (serious) adverse event conform the definition of clinicaltrials.gov
|
0.00%
0/21 • One month postoperative collection of (serious) adverse event conform the definition of clinicaltrials.gov
|
0.00%
0/29 • One month postoperative collection of (serious) adverse event conform the definition of clinicaltrials.gov
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place