Comparison of the TOFScan and the WiTOF During Recovery of Neuromuscular Function

Sponsor

Poitiers University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05231525

Collaborator

(none)

Enrollment

Location

Arms

6.4

Anticipated Duration (Months)

12.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to compare two neuromuscular blockade monitors on recovery from an ATRACURIUM intra veinous injection for surgery. The TOFscan, a wired connected monitors and the WiTOF, a wireless connected monitor.

Condition or Disease	Intervention/Treatment	Phase
Neuromuscular Residual Curarization	Device: WiTOF Device: TOFscan	N/A

Detailed Description

The secondary objective will be to compare the performance of the two monitors on the abductor pollicis muscle with all the curarisation parameters (TOF, PTC, T4/T1R) and to assess interference occuring during the surgery which could limit the usage of a wireless monitor.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Recovery Evaluation of Two Neuromuscular Blockade Monitoring Devices on Abductor Pollicis Muscle, the TOFScan and the Wireless WiTOF

Actual Study Start Date :

Mar 9, 2022

Actual Primary Completion Date :

Jun 21, 2022

Anticipated Study Completion Date :

Sep 21, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: WiTOF	Device: WiTOF Data collection on the WiTOF monitor
Active Comparator: TOFscan	Device: TOFscan Data collection on the TOFscan monitor

Arm

Intervention/Treatment

Experimental: WiTOF

Device: WiTOF

Data collection on the WiTOF monitor

Active Comparator: TOFscan

Device: TOFscan

Data collection on the TOFscan monitor

Outcome Measures

Primary Outcome Measures

Evaluate the neuromuscular blockade recovery after intraveinous injection of atracurium with 2 differents monitors. [During the whole period of the surgical operation maximum 8 hours]
Comparison on the obtention delay for the T4/T1 ratio superior ou equal to 90% beetween the WiTOF and the TOFScan

Secondary Outcome Measures

Evaluate the performance of the monitors for the follow up of neuromuscular recovery [During the whole period of the surgical operation maximum 8 hours]
Comparison of neuromuscular blockade parameters obtained with the WiTOF and the TOFScan (TOF, PTC, T4/1R)
Number and duration of perturbation from the surgical environnement that could limit the usage of a wireless monitor [During the whole period of the surgical operation maximum 8 hours]
Assess what could perturbate the data collection on the wireless monitor

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

All programmed surgery with intraveinous injection of ATRACURIUM
American society of anesthesiology patient score of I, II or III
Patient being free of tutorship or curatorship
Acceptance of the patient after clear and loyal information

Exclusion Criteria:

Surgery without access simultaneously to the two arms
Emergency surgery
Rapid sequence induction
Usage of an other curare than ATRACURIUM
Contraindication on ATRACURIUM usage
Patient with pace maker
Patient with Arné score > or = to 11
Patient without social security coverage
Pregnant of breastfeeding women
Patient under social protection

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU de Poitiers	Poitiers		France	86021

Sponsors and Collaborators

Poitiers University Hospital

Investigators

Principal Investigator: Matthieu BOISSON, CHU de Poitiers FRANCE

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Poitiers University Hospital

ClinicalTrials.gov Identifier:

NCT05231525

Other Study ID Numbers:

WiTOF

First Posted:

Feb 9, 2022

Last Update Posted:

Jun 23, 2022

Last Verified:

Mar 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jun 23, 2022