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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intubating Conditions Based On The Ratio Between The Twitch Amplitude And Reference Twitch Amplitude: A Randomized, Prospective, Clinical Trial
- ClinicalTrials.gov ID
- NCT07483164
- Acronym / sponsor ID
- 25-014117
- Conditions
- Intubation
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 31 Dec 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 19 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| T1/Tref <0.1 | Experimental | Device: Twitch amplitude <0.1Participants will be intubated once the ratio of the twitch amplitude to the reference twitch amplitude (T1/Tref) <0.1 (deeper level of block) |
| T1/Tref <0.3 | Experimental | Other: Twitch amplitude <0.3Participants will be intubated once the ratio of the twitch amplitude to the reference twitch amplitude T1/Tref <0.3 (intermediate depth of block) |
| T1/Tref <0.5 | Experimental | Other: Twitch amplitude <0.5Participants will be intubated once the ratio of the twitch amplitude to the reference twitch amplitude T1/Tref <0.5 (shallower level of block) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age > or = 18 years old
- Patients willing to participate and provide an integrated, informed consent
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Twitch amplitude <0.1(T1/Tref) <0.1 | Device | T1/Tref <0.1 |
| Twitch amplitude <0.3(T1/Tref) <0.3 | Other | T1/Tref <0.3 |
| Twitch amplitude <0.5(T1/Tref) <0.5 | Other | T1/Tref <0.5 |
Primary outcome
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
12 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
J. Ross Renew, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum T1/Tref ratio associated with excellent intubating conditions (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.