IntubationNCT07483164
A Study Of T1/Tref Intubating Conditions
A study testing Twitch amplitude <0.1, Twitch amplitude <0.3 and Twitch amplitude <0.5 in people with Intubation, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intubation
- What is being tested?
- Twitch amplitude <0.1, Twitch amplitude <0.3 and Twitch amplitude <0.5
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Dec 2026to 31 Dec 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > or = 18 years old
- Patients willing to participate and provide an integrated, informed consent
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Intubation
- Being tested
- Twitch amplitude <0.1, Twitch amplitude <0.3, Twitch amplitude <0.5
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Twitch amplitude <0.1Device
(T1/Tref) <0.1
Twitch amplitude <0.3Other
(T1/Tref) <0.3
Twitch amplitude <0.5Other
(T1/Tref) <0.5
| Study group | Role | What they receive |
|---|---|---|
| T1/Tref <0.1 | Experimental | Participants will be intubated once the ratio of the twitch amplitude to the reference twitch amplitude (T1/Tref) <0.1 (deeper level of block) Receives: Device: Twitch amplitude <0.1 |
| T1/Tref <0.3 | Experimental | Participants will be intubated once the ratio of the twitch amplitude to the reference twitch amplitude T1/Tref <0.3 (intermediate depth of block) Receives: Other: Twitch amplitude <0.3 |
| T1/Tref <0.5 | Experimental | Participants will be intubated once the ratio of the twitch amplitude to the reference twitch amplitude T1/Tref <0.5 (shallower level of block) Receives: Other: Twitch amplitude <0.5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline
Secondary outcomes (12)
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Baseline
Proportion of patients with poor 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 poor intubation conditions (using Copenhagen Consensus Conference Intubation Score)
Measured: Baseline
Proportion of patients with excellent intubating conditions at predefined T1/Tred threshold: <0.5
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)
Measured: Baseline
Proportion of patients with good intubating conditions at predefined T1/Tred threshold: <0.5
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)
Measured: Baseline
Proportion of patients with poor intubating conditions at predefined T1/Tred threshold: <0.5
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)
Measured: Baseline
Time to reach specific neuromuscular block level from rocuronium administration to achieving T1/Tref <0.1
Time to reach specific neuromuscular block level from rocuronium administration to achieving T1/Tref <0.1 will be reported in seconds
Measured: Baseline
Time to reach specific neuromuscular block level from rocuronium administration to achieving T1/Tref <0.3
Time to reach specific neuromuscular block level from rocuronium administration to achieving T1/Tref <0.3 will be reported in seconds
Measured: Baseline
Time to reach specific neuromuscular block level from rocuronium administration to achieving T1/Tref <0.5
Time to reach specific neuromuscular block level from rocuronium administration to achieving T1/Tref <0.5 will be reported in seconds
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study start31 Dec 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IntubationStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, J. Ross Renew, M.D., Mayo Clinic
- Investigators
- J. Ross Renew, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07483164
- Sponsor's protocol ID
- 25-014117
- Status last verified
- Oct 2026
- First submitted
- 16 Mar 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No