Intubation
Conditions
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.
Interventions
DEVICETwitch amplitude <0.1
(T1/Tref) \<0.1
OTHERTwitch amplitude <0.3
(T1/Tref) \<0.3
OTHERTwitch amplitude <0.5
(T1/Tref) \<0.5
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum T1/Tref ratio associated with excellent intubating conditions | 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
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with excellent intubating conditions at predefined T1/Tred threshold: <0.1 | 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) |
| Proportion of patients with good intubating conditions at predefined T1/Tred threshold: <0.1 | 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) |
| Proportion of patients with poor intubating conditions at predefined T1/Tred threshold: <0.1 | 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) |
| Proportion of patients with excellent intubating conditions at predefined T1/Tred threshold: <0.3 | 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) |
| Proportion of patients with good intubating conditions at predefined T1/Tred threshold: <0.3 | 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) |
| Proportion of patients with poor intubating conditions at predefined T1/Tred threshold: <0.3 | 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) |
| Proportion of patients with excellent intubating conditions at predefined T1/Tred threshold: <0.5 | 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) |
| Proportion of patients with good intubating conditions at predefined T1/Tred threshold: <0.5 | 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) |
| Proportion of patients with poor intubating conditions at predefined T1/Tred threshold: <0.5 | 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) |
| Time to reach specific neuromuscular block level from rocuronium administration to achieving T1/Tref <0.1 | Baseline | Time to reach specific neuromuscular block level from rocuronium administration to achieving T1/Tref \<0.1 will be reported in seconds |
| Time to reach specific neuromuscular block level from rocuronium administration to achieving T1/Tref <0.3 | Baseline | Time to reach specific neuromuscular block level from rocuronium administration to achieving T1/Tref \<0.3 will be reported in seconds |
| Time to reach specific neuromuscular block level from rocuronium administration to achieving T1/Tref <0.5 | Baseline | Time to reach specific neuromuscular block level from rocuronium administration to achieving T1/Tref \<0.5 will be reported in seconds |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJ. Ross Renew, MD
Mayo Clinic
Outcome results
None listed