A Study Of T1/Tref Intubating Conditions

N/AEnrolling By InvitationNCT07483164

Mayo Clinic108 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

108

Conditions

Intubation

Interventions

Twitch amplitude <0.1DEVICE

(T1/Tref) \<0.1

Twitch amplitude <0.3OTHER

(T1/Tref) \<0.3

Twitch amplitude <0.5OTHER

(T1/Tref) \<0.5

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (1)

Mayo Clinic in Florida

Jacksonville, Florida, United States

Outcomes

Primary Outcomes

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

Time frame: Baseline

Secondary Outcomes

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

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)

Time frame: Baseline

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

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)

Time frame: Baseline

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

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)

Time frame: Baseline

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

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)

Time frame: Baseline

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

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)

Data from ClinicalTrials.gov

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