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Neurostimulation and Electromyographic Assessment of the TetraGraph

Neurostimulation and Electromyographic Assessment of the TetraGraph - NEAT

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON40867
Enrollment
30
Registered
2014-08-08
Start date
2014-09-12
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

algehele anesthesie met spierverslappers anesthetized and neuromuscular blockade

Interventions

None listed

Sponsors

Anesthesiologie - Onderzoeksbureau
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: - Age 18 years or older; - Subject meets the American Society of Anesthesiology (ASA) physical status I-III criteria (Table I); - Subject has provided written informed consent.

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - - Presence of an underlying neuromuscular disease - Presence of renal or hepatic disease - Subject has open skin sores at locations needed for electrode application - Patient is taking the following medication: - anti-seizure medication - anti-cholinestase medication - magnesium sulfate

Design outcomes

Primary

MeasureTime frame
The primary objective of this study is to provide safety and performance data of the TetraGraph device on anesthetized subjects. Performance will be assessed post hoc by analyzing objective EMG data and correlating with the responses to annotations made during the surgical procedure (e.g., correlating the EMG responses to the time of NMBA administration)

Secondary

MeasureTime frame
- Investigating the quality of the applied skin electrodes (clinically available 3M Red Dot electrodes) - Observing the applicability of the prototype (easy of use, *)

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)