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Enrolling by Invitation

NCT Number: NCT07483164

A Study Of T1/Tref Intubating Conditions

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.

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Key information

Conditions

Intubation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Twitch amplitude <0.1

Device

(T1/Tref) <0.1

Twitch amplitude <0.3

Other

(T1/Tref) <0.3

Twitch amplitude <0.5

Other

(T1/Tref) <0.5

Primary outcomes

  1. 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

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. 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)

  9. 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)

  10. 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

  11. 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

  12. 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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 19, 2026
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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