Comparison of Two Neuromuscular Transmission Monitors Based on Acceleromyography: TOF-Watch SX® and TOFScan®
TOFScan
1 other identifier
interventional
142
1 country
1
Brief Summary
The purpose is to evaluate the reproducibility of neuromuscular monitoring data of recovery from neuromuscular blockade, obtained with TOFScan® and TOF-Watch SX®, in adult and pediatric population. Secondary purposes are to evaluate the reproducibility of data obtained with 2 monitors for:
- the onset of clinical action of curare: suppression of the first response of train of four monitoring (T1) of 95% initial value
- the duration of clinical action of curare: recovery of the first response of train of four monitoring (T1) to 25% initial value
- recovery of first (T1), second (T2), third (T3) and fourth response (T4) of train of four monitoring, and recovery of T4/T1 to 40% and 60% initial value (T4/T1 0.4 and 0.6)
- complete recovery from curarisation, at T4/T1=90% and T4/T1=100%.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2014
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2014
CompletedFirst Submitted
Initial submission to the registry
August 18, 2016
CompletedFirst Posted
Study publicly available on registry
August 26, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedAugust 26, 2016
August 1, 2016
2.1 years
August 18, 2016
August 23, 2016
Conditions
Outcome Measures
Primary Outcomes (8)
Time of recovery of the first (T1) response of train of four monitoring displayed on TOFScan and on TOF Watch SX
day 0, after induction of anesthesia
Time of recovery of the second (T2) response of train of four monitoring displayed on TOFScan and on TOF Watch SX
day 0, after induction of anesthesia
Time of recovery of the third (T3) response of train of four monitoring displayed on TOFScan and on TOF Watch SX
day 0, after induction of anesthesia
Time of recovery of the fourth (T4) response of train of four monitoring displayed on TOFScan and on TOF Watch SX
day 0, after induction of anesthesia
Time of recovery of T4/T1 of train of four monitoring at 40% of initial value displayed on TOFScan and on TOF Watch SX
day 0, after induction of anesthesia
Time of recovery of T4/T1 of train of four monitoring at 60% of initial value displayed on TOFScan and on TOF Watch SX
day 0, after induction of anesthesia
Time of recovery of T4/T1 of train of four monitoring at 90% of initial value displayed on TOFScan and on TOF Watch SX
day 0, after induction of anesthesia
Time of recovery of T4/T1 of train of four monitoring at 100% of initial value displayed on TOFScan and on TOF Watch SX
day 0, after induction of anesthesia
Secondary Outcomes (2)
Time of suppression of the first response of train of four monitoring (T1) at 95% initial value displayed on TOFScan and on TOF Watch SX
day 0, after induction of anesthesia
Time of recovery of the first response of train of four monitoring (T1) to 25% initial value displayed on TOFScan and on TOF Watch SX
day 0, after induction of anesthesia
Study Arms (4)
Adult population 1
OTHERTOF-Watch SX® on nondominant arm and TOFScan® on dominant arm
Adult population 2
OTHERTOF-Watch SX® on dominant arm and TOFScan® on nondominant arm
Pediatric population 1
OTHERTOF-Watch SX® on nondominant arm and TOFScan® on dominant arm
Pediatric population 2
OTHERTOF-Watch SX® on dominant arm and TOFScan® on nondominant arm
Interventions
Anesthesia induction with Propofol and maintaining with desflurane. For adult patients, the curare is rocuronium (0.6 mg/kg) For pediatric patients, the curare can be rocuronium (0.6 mg/kg), cisatracurium (0.1 mg/kg) or atracurium (0.5 mg/kg)
Each monitor on one arm
Eligibility Criteria
You may qualify if:
- Adult population:
- Non opposition to research
- \> 18 years old
- ASA score 1-3
- Undergoing surgery with curarisation through tracheal intubation
- Affiliation to social security
- Pediatric population:
- \> 1 year old
- Non opposition to research of child (if able to consent) or representatives with parental authority
- ASA score 1-4
- Undergoing surgery with curarisation
- Affiliation to social security
You may not qualify if:
- Adult population:
- Allergy to administered drugs
- Known or suspected difficult intubation
- Pregnant women
- BMI \> 40
- Pediatric population:
- Allergy to administered drugs
- Known or suspected difficult intubation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHRU de NANCY - Hôpitaux de Brabois - Département d'Anesthésie-Réanimation
Vandœuvre-lès-Nancy, France
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas FUCHS-BUDER, Pr
CHRU de NANCY - Hôpitaux de Brabois - Département d'Anesthésie-Réanimation - VANDOEUVRE LES NANCY - FRANCE
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 18, 2016
First Posted
August 26, 2016
Study Start
November 1, 2014
Primary Completion
December 1, 2016
Study Completion
December 1, 2016
Last Updated
August 26, 2016
Record last verified: 2016-08
Data Sharing
- IPD Sharing
- Will not share