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Enrolling by invitation NCT07483164

A Study Of T1/Tref Intubating Conditions

No phase Interventional Intubation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Twitch amplitude <0.1, Twitch amplitude <0.3, Twitch amplitude <0.5.
Who it may be relevant to
Registry conditions: Intubation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Device Twitch amplitude <0.1
    (T1/Tref) \<0.1
  • Other Twitch amplitude <0.3
    (T1/Tref) \<0.3
  • Other Twitch amplitude <0.5
    (T1/Tref) \<0.5

Primary outcome measures

  • Maximum T1/Tref ratio associated with excellent intubating conditions [Time frame: Baseline]
Secondary outcome measures (12)
  • Proportion of patients with excellent intubating conditions at predefined T1/Tred threshold: <0.1 [Time frame: Baseline]
  • Proportion of patients with good intubating conditions at predefined T1/Tred threshold: <0.1 [Time frame: Baseline]
  • Proportion of patients with poor intubating conditions at predefined T1/Tred threshold: <0.1 [Time frame: Baseline]
  • Proportion of patients with excellent intubating conditions at predefined T1/Tred threshold: <0.3 [Time frame: Baseline]
  • Proportion of patients with good intubating conditions at predefined T1/Tred threshold: <0.3 [Time frame: Baseline]
  • Proportion of patients with poor intubating conditions at predefined T1/Tred threshold: <0.3 [Time frame: Baseline]
  • Proportion of patients with excellent intubating conditions at predefined T1/Tred threshold: <0.5 [Time frame: Baseline]
  • Proportion of patients with good intubating conditions at predefined T1/Tred threshold: <0.5 [Time frame: Baseline]
  • Proportion of patients with poor intubating conditions at predefined T1/Tred threshold: <0.5 [Time frame: Baseline]
  • 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 <0.3 [Time frame: Baseline]
  • Time to reach specific neuromuscular block level from rocuronium administration to achieving T1/Tref <0.5 [Time frame: Baseline]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

United States · 1 center
  • Mayo Clinic in Florida — Jacksonville

Identifiers

NCT: NCT07483164 · 25-014117

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗