NCT02350062

Brief Summary

Different neuromuscular monitors may be available in the same care structure. Two different monitors are available in the investigators' institution in the operative room and the recovery room. However, these two monitors have not been compared and may not be interchangeable. Starting the monitoring with one device and continuing with another device may be inaccurate and may lead to inadequate medical decisions. The investigators therefore conducted this observational study to compare the two devices available in our institution.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2014

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

November 27, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 29, 2015

Completed
Last Updated

January 29, 2015

Status Verified

January 1, 2015

Enrollment Period

2 months

First QC Date

November 27, 2014

Last Update Submit

January 28, 2015

Conditions

Neuromuscular Monitoring

Outcome Measures

Primary Outcomes (1)

  • Time to recover T4/T1 > 90%

    After muscle relaxant injection, we measure the time needed for the muscular response to disappear and to completely recover during the operation (which takes in average 2 hours).

    Time between muscle relaxant injection and: intubation; recovery of 4 responses on the train of four (TOF); recovery of T4/T1 >40%; recovery of T4/T1>90% average 2 hours

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients undergoing vascular surgery under general anesthesia and requiring neuromuscular blockade for intubation or surgery

You may qualify if:

  • Patients undergoing vascular surgery under general anesthesia and requiring neuromuscular blockade for intubation or surgery

You may not qualify if:

  • Pregnancy or feeding
  • Any pathology or medication that may impair neuromuscular conduction or muscular response of the ulnar nerve stimulation
  • American Society of Anesthesiology \[4\] physical status
  • Allergy or contraindication of neuromuscular blocking agents

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Georges Daccache, M.D

    University Hospital, Caen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2014

First Posted

January 29, 2015

Study Start

January 1, 2014

Primary Completion

March 1, 2014

Study Completion

November 1, 2014

Last Updated

January 29, 2015

Record last verified: 2015-01