A Study Of T1/Tref Intubating Conditions

NCT07483164 | Enrolling By Invitation FDA Device

• 1 other identifier: 25-014117
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the maximum ratio of the twitch amplitude (T1) to the reference twitch (Tref) amplitude (T1/Tref) that provides excellent intubating conditions.

Conditions

Intubation

Outcome Measures

Primary Outcomes (1)

• Maximum T1/Tref ratio associated with excellent intubating conditions

  The T1/Tref ratio that leads to the highest proportion of patients being intubated under excellent conditions: T1/Tref \<0.1, T1/Tref \<0.3, or T1/Tref \<0.5

  Baseline

Secondary Outcomes (12)

• Proportion of patients with excellent intubating conditions at predefined T1/Tred threshold: <0.1

  Baseline

• Proportion of patients with good intubating conditions at predefined T1/Tred threshold: <0.1

  Baseline

• Proportion of patients with poor intubating conditions at predefined T1/Tred threshold: <0.1

  Baseline

• Proportion of patients with excellent intubating conditions at predefined T1/Tred threshold: <0.3

  Baseline

• Proportion of patients with good intubating conditions at predefined T1/Tred threshold: <0.3

  Baseline

Study Arms (3)

T1/Tref <0.1

EXPERIMENTAL

Participants will be intubated once the ratio of the twitch amplitude to the reference twitch amplitude (T1/Tref) \<0.1 (deeper level of block)

Device: Twitch amplitude <0.1

T1/Tref <0.3

EXPERIMENTAL

Participants will be intubated once the ratio of the twitch amplitude to the reference twitch amplitude T1/Tref \<0.3 (intermediate depth of block)

Other: Twitch amplitude <0.3

T1/Tref <0.5

EXPERIMENTAL

Participants will be intubated once the ratio of the twitch amplitude to the reference twitch amplitude T1/Tref \<0.5 (shallower level of block)

Other: Twitch amplitude <0.5

Interventions

Twitch amplitude <0.1 DEVICE

(T1/Tref) \<0.1

T1/Tref <0.1

Twitch amplitude <0.3 OTHER

(T1/Tref) \<0.3

T1/Tref <0.3

Twitch amplitude <0.5 OTHER

(T1/Tref) \<0.5

T1/Tref <0.5

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> or = 18 years old
• Patients willing to participate and provide an integrated, informed consent

You may not qualify if:

• Patients with disorders, such as stroke, carpal tunnel syndrome, broken wrist with nerve damage, Dupuytren contracture, or any similar wrist injury.
• Patients with systemic neuromuscular diseases such as myasthenia gravis.
• Patients with significant organ dysfunction that can significantly affect pharmacokinetics of neuromuscular blocking and reversal agents, i.e., severe renal impairment requiring dialysis or end-stage liver disease.
• Patients requiring a rapid sequence induction for airway protection.
• Patients deemed ineligible for surgery, including pregnancy (as determined by standard of care testing).

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

Related Links

• Mayo Clinic Clinical Trials

Study Officials

• J. Ross Renew, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 16, 2026
• First Posted: March 19, 2026
• Study Start: May 31, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 19, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)