A Study Of T1/Tref Intubating Conditions

May 18, 2026 updated by: J. Ross Renew, M.D., Mayo Clinic

Intubating Conditions Based On The Ratio Between The Twitch Amplitude And Reference Twitch Amplitude: A Randomized, Prospective, Clinical Trial

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

108

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic in Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria

  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: T1/Tref <0.1
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) <0.1
Experimental: T1/Tref <0.3
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) <0.3
Experimental: T1/Tref <0.5
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
(T1/Tref) <0.5

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum T1/Tref ratio associated with excellent intubating conditions
Time Frame: Baseline
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to reach specific neuromuscular block level from rocuronium administration to achieving T1/Tref <0.1
Time Frame: Baseline
Time to reach specific neuromuscular block level from rocuronium administration to achieving T1/Tref <0.1 will be reported in seconds
Baseline
Time to reach specific neuromuscular block level from rocuronium administration to achieving T1/Tref <0.3
Time Frame: Baseline
Time to reach specific neuromuscular block level from rocuronium administration to achieving T1/Tref <0.3 will be reported in seconds
Baseline
Time to reach specific neuromuscular block level from rocuronium administration to achieving T1/Tref <0.5
Time Frame: Baseline
Time to reach specific neuromuscular block level from rocuronium administration to achieving T1/Tref <0.5 will be reported in seconds
Baseline
Proportion of patients with excellent intubating conditions at predefined T1/Tred threshold: <0.1
Time Frame: Baseline
Percentage of patients, out of total patients in the T1/Tref <0.1 arm, considered to have excellent intubation conditions (using Copenhagen Consensus Conference Intubation Score)
Baseline
Proportion of patients with good intubating conditions at predefined T1/Tred threshold: <0.1
Time Frame: Baseline
Percentage of patients, out of total patients in the T1/Tref <0.1 arm considered to have good intubation conditions (using Copenhagen Consensus Conference Intubation Score)
Baseline
Proportion of patients with poor intubating conditions at predefined T1/Tred threshold: <0.1
Time Frame: Baseline
Percentage of patients, out of total patients in the T1/Tref <0.1 arm, considered to have poor intubation conditions (using Copenhagen Consensus Conference Intubation Score)
Baseline
Proportion of patients with excellent intubating conditions at predefined T1/Tred threshold: <0.3
Time Frame: Baseline
Percentage of patients, out of total patients in the T1/Tref <0.3 arm, considered to have excellent intubation conditions (using Copenhagen Consensus Conference Intubation Score)
Baseline
Proportion of patients with good intubating conditions at predefined T1/Tred threshold: <0.3
Time Frame: Baseline
Percentage of patients, out of total patients in the T1/Tref <0.3 arm, considered to have good intubation conditions (using Copenhagen Consensus Conference Intubation Score)
Baseline
Proportion of patients with poor intubating conditions at predefined T1/Tred threshold: <0.3
Time Frame: Baseline
Percentage of patients, out of total patients in the T1/Tref <0.3 arm, considered to have poor intubation conditions (using Copenhagen Consensus Conference Intubation Score)
Baseline
Proportion of patients with excellent intubating conditions at predefined T1/Tred threshold: <0.5
Time Frame: Baseline
Percentage of patients, out of total patients in the T1/Tref <0.5 arm, considered to have excellent intubation conditions (using Copenhagen Consensus Conference Intubation Score)
Baseline
Proportion of patients with good intubating conditions at predefined T1/Tred threshold: <0.5
Time Frame: Baseline
Percentage of patients, out of total patients in the T1/Tref <0.5 arm, considered to have good intubation conditions (using Copenhagen Consensus Conference Intubation Score)
Baseline
Proportion of patients with poor intubating conditions at predefined T1/Tred threshold: <0.5
Time Frame: Baseline
Percentage of patients, out of total patients in the T1/Tref <0.5 arm, considered to have poor intubation conditions (using Copenhagen Consensus Conference Intubation Score)
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: J. Ross Renew, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 31, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

March 16, 2026

First Submitted That Met QC Criteria

March 16, 2026

First Posted (Actual)

March 19, 2026

Study Record Updates

Last Update Posted (Actual)

May 19, 2026

Last Update Submitted That Met QC Criteria

May 18, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 25-014117

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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