Acute Respiratory FailureDO-RSINCT03420950
Drug Order for Rapid Sequence Intubation
A study testing Rapid sequence intubation: sedative first and Rapid sequence intubation: paralytic first in people with Acute Respiratory Failure, run by Hennepin Healthcare Research Institute at 1 site in United States.
Trial summary
This is a randomized, blinded trial comparing the order of drug administration for rapid sequence intubation in the Emergency Department. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Failure
- What is being tested?
- Rapid sequence intubation: sedative first and Rapid sequence intubation: paralytic first
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 335 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Feb 2018to 29 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- The patient must be undergoing orotracheal intubation in the Emergency Department
- The patient must be receiving both a sedative and paralytic immediately prior to intubation (i.e. undergoing rapid sequence intubation).
- The patient must be presumed to be 18 years of age or older at the time of enrollment.
Who cannot join
- Prisoner or in custody
- Known or suspected to be pregnant, based on the opinion of the attending physician.
- Intubation performed by a physician assistant (this is rarely done in our ED; each physician assistant intubates less than twice per year, so the intubation outcomes would hinge more on their experience rather than drug order).
Trial locations and contacts
1 site in 1 country.
United States1 site
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
About this study
Official title: Drug Order for Rapid Sequence Intubation in Emergency Department Intubation
This is a randomized, blinded trial comparing the order of drug administration for rapid sequence intubation in the Emergency Department.
Read the detailed description
Based on data (excluding outliers) from protocol 16-4146, the intubation time with the paralytic and sedative first administered is 86 s, and 93 s, respectively, with a standard deviation of approximately 25-30 s. Using these assumptions, 470 patients (235 per group) will need to be enrolled to detect an 7 s absolute difference between groups with 80% power.
Because a greater difference is anticipated in those who receive rocuronium rather than succinylcholine (because succinylcholine takes action faster), goal enrollment is 470 patients who receive rocuronium as the paralytic who are intubated successfully on the first attempt. The total enrollment will be higher, accounting for those who receive succinylcholine and those who are not successful on the first attempt. The data for those who receive succinylcholine first will be reported and is planned to be used to determine the feasibility of a future trial.
The primary group of analysis will be those receiving rocuronium, because this medication acts somewhat slower than succinylcholine. Patients who receive either drug will be analyzed, but it is pre-specified that the group of interest are those receiving rocuronium.
The primary outcome, first intubation attempt duration, and apnea duration will be measured only in those with a successful first attempt because these timing events will be confounded by attempt failure; in these cases the altered duration will have more to do with device or patient characteristics than with drug order.
The remainder of the outcomes will be measured in all enrolled subjects in an intention to treat analysis.
An analysis for patients by RSI drug order actually received, regardless of treatment allocation, will also be presented.
- Conditions
- Acute Respiratory Failure
- Being tested
- Rapid sequence intubation: sedative first, Rapid sequence intubation: paralytic first
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapid sequence intubation: sedative firstOther
Sedative first
Rapid sequence intubation: paralytic firstOther
Paralytic first
| Study group | Role | What they receive |
|---|---|---|
| Sedative first | Other | Rapid sequence intubation: sedative first Receives: Other: Rapid sequence intubation: sedative first |
| Paralytic agent first | Other | Rapid sequence intubation: paralytic first Receives: Other: Rapid sequence intubation: paralytic first |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time elapsed from drug administration to intubation attempt end
The primary outcome will be time from complete administration of the first medication to successful first attempt intubation. This timing period will begin when the first RSI agent is completely administered and end when the laryngoscope blade is removed from the mouth. Attempts that are not successful on the first attempt will be excluded from the primary outcome measure because the time to intubation will be confounded by the failure; in these cases the altered duration will have more to do with device or patient characteristics than with drug order.
Measured: 5 minutes
Secondary outcomes (5)
Duration of first intubation attempt
Defined as the time elapsed between inserting and removing the laryngoscope blade from the mouth. The primary outcome, duration of the first intubation attempt, and apnea duration will only be measured in those with a successful first attempt.
Measured: 5 minutes
Hypoxemia
Oxygen saturation < 90%, during the time interval between the start of the intubation attempt and 1 minute following completion of the attempt.
Measured: 5 minutes
Best laryngeal view
Cormack-Lehane grade
Measured: 5 minutes
Best laryngeal view
Percent of glottic opening
Measured: 5 minutes
First intubation attempt success
Defined as successful intubation with a single insertion of the laryngoscope, regardless of the number of passages of the endotracheal tube or bougie.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start5 Feb 2018
- Primary completion29 Sep 2021
- Study completion29 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory FailureStudies of the same condition, open and under way.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 335 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hennepin Healthcare Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian Driver, Hennepin Healthcare Research Institute
- Investigators
- Brian Driver, MD, Principal investigator, Hennepin County Medical Center, Minneapolis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03420950
- Sponsor's protocol ID
- 17-4432
- Acronym
- DO-RSI
- Status last verified
- Jan 2022
- First submitted
- 28 Jan 2018
- Last updated
- 3 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug Order for Rapid Sequence Intubation in Emergency Department Intubation
- ClinicalTrials.gov ID
- NCT03420950
- Acronym / sponsor ID
- DO-RSI / 17-4432
- Conditions
- Acute Respiratory Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 335 participants (actual)
- Lead sponsor
- Hennepin Healthcare Research InstituteUniversity, hospital or other
- Study start
- 5 Feb 2018 (actual)
- Primary completion
- 29 Sep 2021 (actual)
- Study completion
- 29 Sep 2021 (actual)
- First posted
- 5 Feb 2018 (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.
This is a randomized, blinded trial comparing the order of drug administration for rapid sequence intubation in the Emergency Department.
Detailed description
Based on data (excluding outliers) from protocol 16-4146, the intubation time with the paralytic and sedative first administered is 86 s, and 93 s, respectively, with a standard deviation of approximately 25-30 s. Using these assumptions, 470 patients (235 per group) will need to be enrolled to detect an 7 s absolute difference between groups with 80% power.
Because a greater difference is anticipated in those who receive rocuronium rather than succinylcholine (because succinylcholine takes action faster), goal enrollment is 470 patients who receive rocuronium as the paralytic who are intubated successfully on the first attempt. The total enrollment will be higher, accounting for those who receive succinylcholine and those who are not successful on the first attempt. The data for those who receive succinylcholine first will be reported and is planned to be used to determine the feasibility of a future trial.
The primary group of analysis will be those receiving rocuronium, because this medication acts somewhat slower than succinylcholine. Patients who receive either drug will be analyzed, but it is pre-specified that the group of interest are those receiving rocuronium.
The primary outcome, first intubation attempt duration, and apnea duration will be measured only in those with a successful first attempt because these timing events will be confounded by attempt failure; in these cases the altered duration will have more to do with device or patient characteristics than with drug order.
The remainder of the outcomes will be measured in all enrolled subjects in an intention to treat analysis.
An analysis for patients by RSI drug order actually received, regardless of treatment allocation, will also be presented.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sedative first | Other | Other: Rapid sequence intubation: sedative firstRapid sequence intubation: sedative first |
| Paralytic agent first | Other | Other: Rapid sequence intubation: paralytic firstRapid sequence intubation: paralytic first |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The patient must be undergoing orotracheal intubation in the Emergency Department
- The patient must be receiving both a sedative and paralytic immediately prior to intubation (i.e. undergoing rapid sequence intubation).
- The patient must be presumed to be 18 years of age or older at the time of enrollment.
Key exclusion criteria (3 listed)
- Prisoner or in custody
- Known or suspected to be pregnant, based on the opinion of the attending physician.
- Intubation performed by a physician assistant (this is rarely done in our ED; each physician assistant intubates less than twice per year, so the intubation outcomes would hinge more on their experience rather than drug order).
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 |
|---|---|---|
| Rapid sequence intubation: sedative firstSedative first | Other | Sedative first |
| Rapid sequence intubation: paralytic firstParalytic first | Other | Paralytic agent first |
Primary outcome
Time elapsed from drug administration to intubation attempt end
Time frame: 5 minutes
The primary outcome will be time from complete administration of the first medication to successful first attempt intubation. This timing period will begin when the first RSI agent is completely administered and end when the laryngoscope blade is removed from the mouth. Attempts that are not successful on the first attempt will be excluded from the primary outcome measure because the time to intubation will be confounded by the failure; in these cases the altered duration will have more to do with device or patient characteristics than with drug order.
5 secondary outcomes
Duration of first intubation attempt
Time frame: 5 minutes
Hypoxemia
Time frame: 5 minutes
Best laryngeal view
Time frame: 5 minutes
Best laryngeal view
Time frame: 5 minutes
First intubation attempt success
Time frame: 5 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2022.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Brian Driver, MD principal investigator
Hennepin County Medical Center, Minneapolis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rapid sequence intubation: sedative first and Rapid sequence intubation: paralytic first in people with Acute Respiratory Failure, run by Hennepin Healthcare Research Institute 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 3 Feb 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time elapsed from drug administration to intubation attempt end (time frame: 5 minutes). 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 3 Feb 2022.