SurgeryNCT05964166

Tetragraph® Monitor: Tolerance of Preoperative Placement

A study testing TetraGraph NMT Monitor in people with Surgery, run by Joseph D. Tobias at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This is a prospective, non-blinded, single arm study. The primary objective of this study is to evaluate the tolerance to preoperative placement of the adhesive sensor for the Tetragraph® Neuromuscular Transmission Monitor in pediatric-sized patients ≤ 12 years of age. Read more about this study

Who is it for?: Ages 3 months to 12 years
Conditions the study is for: Surgery
What is being tested?: TetraGraph NMT Monitor
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteUnited States
Study dates: 31 May 2023to 1 Aug 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 3 months to 12 years
All sexes
No healthy volunteers
Child

Who may be able to join

Patients requiring anesthetic care and use of neuromuscular blockade
Age ≤ 12 years
ASA 1-4

Who cannot join

History of a peripheral neurologic or neuropathic disorder
Upper extremity cannot be used for TOF monitoring
Undergoing a surgical procedure in which neuromuscular blockade is not required
Patient is edematous
Patients with significant behavioral or neurocognitive issues which affect behavior and impact the ability to place the sensor

Trial locations and contacts

1 site in 1 country.

United States1 site

Nationwide Children's Hospital
Columbus, Ohio, 43205

Other trials in United States

About this study

Conditions: Surgery
Being tested: TetraGraph NMT Monitor

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TetraGraph NMT MonitorDevice
TetraGraph is a unique, EMG=based portable device for quantitative (objective) monitoring of neuromuscular function. It is a precise and easy to use tool for monitoring depth of block, ensuring adequate recovery of muscle function, and aiding the clinician to reduce the incidence of residual block.

Study groups in NCT05964166
Study group	Role	What they receive
Tetragraph	Experimental	Not described Receives: Device: TetraGraph NMT Monitor

What is being measured

The primary outcome is the main question the study is designed to answer.

Tolerance to Preop Placement as Assessed by Likert Scale
Patient's tolerance to preoperative placement of the adhesive sensor for the Tetragraph® Neuromuscular Transmission Monitor will be assessed by using a 10-point Likert scale with 0=very badly/pulled sensor off and 10=very well/left sensor alone.
Measured: 30 mins. prior to surgery

Secondary outcomes (1)

Application Ease
The ease of preoperative placement of the adhesive sensor for the Tetragraph® Neuromuscular Transmission Monitor will be assessed by the research staff by using a 10-point Likert scale with 0=very difficult and 10=very easy.
Measured: 30 minutes prior to surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 May 20231 Aug 2023

First posted27 Jul 2023
Study start31 May 2023
Primary completion1 Aug 2023
Study completion1 Aug 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for SurgeryStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05964166
Sponsor's protocol ID: STUDY00003295
Status last verified: Oct 2024
First submitted: 2 Jun 2023
Last updated: 18 Nov 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Surgery trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Tetragraph® Monitor: Tolerance of Preoperative Placement
ClinicalTrials.gov ID: NCT05964166
Acronym / sponsor ID: STUDY00003295
Conditions: Surgery
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Joseph D. TobiasUniversity, hospital or other
Study start: 31 May 2023 (actual)
Primary completion: 1 Aug 2023 (actual)
Study completion: 1 Aug 2023 (actual)
First posted: 27 Jul 2023 (actual)
Results: Posted 5 Sep 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Tetragraph	Experimental	Device: TetraGraph NMT Monitor

Who may qualify

Ages: 3 months to 12 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (3 listed)

Patients requiring anesthetic care and use of neuromuscular blockade
Age ≤ 12 years
ASA 1-4

Key exclusion criteria (5 listed)

History of a peripheral neurologic or neuropathic disorder
Upper extremity cannot be used for TOF monitoring
Undergoing a surgical procedure in which neuromuscular blockade is not required
Patient is edematous
Patients with significant behavioral or neurocognitive issues which affect behavior and impact the ability to place the sensor

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TetraGraph NMT MonitorTetraGraph is a unique, EMG=based portable device for quantitative (objective) monitoring of neuromuscular function. It is a precise and easy to use tool for monitoring depth of block, ensuring adequate recovery of muscle function, and aiding the clinician to reduce the incidence of residual block.	Device	Tetragraph

Primary outcome

Tolerance to Preop Placement as Assessed by Likert Scale
Time frame: 30 mins. prior to surgery
Patient's tolerance to preoperative placement of the adhesive sensor for the Tetragraph® Neuromuscular Transmission Monitor will be assessed by using a 10-point Likert scale with 0=very badly/pulled sensor off and 10=very well/left sensor alone.

1 secondary outcome

Application Ease
Time frame: 30 minutes prior to surgery

Results and safety

Results posted to the registry on 5 Sep 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pulled Off Sensor	14	14
Sensor Intact	26	26

Primary outcome: Tolerance to Preop Placement as Assessed by Likert Scale

Time frame: 30 mins. prior to surgery. Median (Inter-Quartile Range). Unit: units on a scale (0-10)

Measure	Pulled Off Sensor n = 14	Sensor Intact n = 26
Research team member assessment	0 (0 to 0)	10 (9 to 10)
Family member assessment	0 (0 to 0)	10 (10 to 10)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Day of surgery. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pulled Off Sensor	0 of 14 (0%)	0 of 14 (0%)	0 of 14
Sensor Intact	0 of 26 (0%)	0 of 26 (0%)	0 of 26

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Surgery

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RecruitingObservational study
Comparison of Hemodynamic Responses During Anesthesia Induction Using Eleveld and Schnider
Spinal (Fusion) Surgery, Total Intravenous Anesthesia
RecruitingPhase 1
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Renal Failure Congenital, Congenital Renal Anomaly Nos
RecruitingPhase 2
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RecruitingPhase 2/3
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing TetraGraph NMT Monitor in people with Surgery, run by Joseph D. Tobias at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tolerance to Preop Placement as Assessed by Likert Scale (time frame: 30 mins. prior to surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05964166.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2024.