Apneic OxygenationRAPIDNCT03694379
Apneic Oxygenation Including Precipitous Intubations During RSI in the ED
A study testing Apneic oxygenation during endotracheal intubation in people with Apneic Oxygenation and Endotracheal Intubation, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
This RCT is testing the efficacy of apneic oxygenation during endotracheal intubation in the emergency department. Currently the standard practice in the ED when performing endotracheal intubation is that some providers use apneic oxygenation (the application of a nasal cannula at 15LPM) throughout the intubation… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Apneic Oxygenation, Endotracheal Intubation
- What is being tested?
- Apneic oxygenation during endotracheal intubation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2019to 22 Mar 2020
- 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 inclusion criteria for our study will include patients 18 years or older who require emergent endotracheal intubation utilizing rapid sequence intubation (RSI) in the Emergency Department with first attempt taken by a resident or attending physician working in the emergency department. This includes Emergency Medicine attending physicians and residents as well as non-Emergency Medicine rotators (e.g.., Internal Medicine residents who are rotating through the Emergency Department).
Who cannot join
- Exclusion criteria include patients who are in cardiac arrest, or if the patient received any positive pressure ventilation (i.e, BPAP, CPAP, BVM) in the emergency department before RSI.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial of Apneic Oxygenation Including Precipitous Intubations During RSI in the Emergency Department
This RCT is testing the efficacy of apneic oxygenation during endotracheal intubation in the emergency department. Currently the standard practice in the ED when performing endotracheal intubation is that some providers use apneic oxygenation (the application of a nasal cannula at 15LPM) throughout the intubation procedure, while others do not apply apneic oxygenation. Initial literature in the operating room showed that apneic oxygenation helps prevent desaturation during the procedure. However, the latest literature conducted in critical care settings (one study in the ICU and one in the ED) questions the efficacy of this intervention in critically ill patients; however, no harm has been shown. Our study aims to test this intervention further by adding in a special subset of patients that was excluded from prior studies, precipitous intubations, or those patients that have to be intubated quickly and cannot have adequate pre-oxygenation. We hypothesize that apneic oxygenation will be more efficacious in this subset than in the overall ED population. We will randomize patients requiring endotracheal intubation into intervention (apneic oxygenation) and control (no apneic oxygenation). We will measure the lowest arterial oxygen saturation from the start of the intubation procedure through 2 minutes after intubation is complete.
- Conditions
- Apneic Oxygenation, Endotracheal Intubation
- Being tested
- Apneic oxygenation during endotracheal intubation
- Keywords
- Apneic Oxygenation, Endotracheal intubation, Airway Management, Emergency Department
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apneic oxygenation during endotracheal intubationOther
Providing oxygenation through nasal cannula during the apneic phase of endotracheal intubation.
| Study group | Role | What they receive |
|---|---|---|
| Apneic Oxygenation | Experimental | Participants receiving apneic oxygenation Receives: Other: Apneic oxygenation during endotracheal intubation |
| No Apneic Oxygenation | No intervention | Participants not receiving apneic oxygenation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lowest oxygen saturation overall
Lowest oxygen saturation between overall control and intervention groups
Measured: Time between neuromuscular blockade and 2 minutes after completion of endotracheal intubation
Secondary outcomes (14)
Lowest oxygen saturation precipitous intubations
Lowest oxygen saturation between control and intervention groups that did not receive adequate pre-oxygenation only
Measured: Time between neuromuscular blockade and 2 minutes after completion of endotracheal intubation
Lowest oxygen saturation pre-oxygenation
Lowest oxygen saturation between control and intervention groups that did receive
Measured: Time between neuromuscular blockade and 2 minutes after completion of endotracheal intubation
Difference in baseline and final oxygen saturation
Measured: Decision to intubate through 2 minutes after completion of endotracheal intubation
Difference in oxygen saturation before and after apneic period
Measured: Initiation of neuromuscular blockade through 2 minutes after completion of endotracheal intubation
Desaturation
The proportion of patients who desaturate below 90%
Measured: Initiation of neuromuscular blockade through 2 minutes after completion of endotracheal intubation
number of attempts
number of times laryngoscope is placed into the mouth in an attempt to pass an endotracheal tube
Measured: From first attempt at intubation through completion of endotracheal intubation procedure, approximately 2 minutes.
Need for second operator
A second physician had to attempt intubation
Measured: From first attempt at intubation through completion of endotracheal intubation procedure, approximately 2 minutes.
Need for additional intubating equipment
The operator needed to change or add equipment to facilitate intubation
Measured: From first attempt at intubation through completion of endotracheal intubation procedure, approximately 2 minutes.
Esophageal intubations
The proportion of intubations that resulted in the endotracheal tube being placed in the esophagus
Measured: From first attempt at intubation through entire ED stay, approximately 6 hours.
Procedural hypotension
Proportion of became hypotensive at any point during the intubation procedure
Measured: Initiation of neuromuscular blockade to 2 minutes after completion of endotracheal intubation
Aspiration
Proportion of patients that had evidence of aspiration
Measured: Within 24 hours after intubation procedure was complete
Hospital length of stay
Number of days patient is hospitalized
Measured: Up to 28 days after intubation
Number of days intubated
Measured: Up to 28 days after intubation
In-hospital mortality
Measured: Up to 28 days after intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2018
- Study start1 Mar 2019
- Primary completion22 Mar 2020
- Study completion22 Mar 2020
Why it stopped: Could not enroll enough patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Apneic OxygenationStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ilya Ostrovsky, MD, Rutgers, The State University of New Jersey
- Investigators
- Ilya Ostrovsky, MD, Principal investigator, Rutgers, The State University of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03694379
- Sponsor's protocol ID
- Pro2018000579
- Acronym
- RAPID
- Status last verified
- Mar 2020
- First submitted
- 11 Sep 2018
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Apneic Oxygenation Including Precipitous Intubations During RSI in the Emergency Department
- ClinicalTrials.gov ID
- NCT03694379
- Acronym / sponsor ID
- RAPID / Pro2018000579
- Conditions
- Apneic Oxygenation, Endotracheal Intubation
- Keywords
- Apneic Oxygenation, Endotracheal intubation, Airway Management, Emergency Department
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Could not enroll enough patients
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 22 Mar 2020 (actual)
- Study completion
- 22 Mar 2020 (actual)
- First posted
- 3 Oct 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 RCT is testing the efficacy of apneic oxygenation during endotracheal intubation in the emergency department. Currently the standard practice in the ED when performing endotracheal intubation is that some providers use apneic oxygenation (the application of a nasal cannula at 15LPM) throughout the intubation procedure, while others do not apply apneic oxygenation. Initial literature in the operating room showed that apneic oxygenation helps prevent desaturation during the procedure. However, the latest literature conducted in critical care settings (one study in the ICU and one in the ED) questions the efficacy of this intervention in critically ill patients; however, no harm has been shown. Our study aims to test this intervention further by adding in a special subset of patients that was excluded from prior studies, precipitous intubations, or those patients that have to be intubated quickly and cannot have adequate pre-oxygenation. We hypothesize that apneic oxygenation will be more efficacious in this subset than in the overall ED population. We will randomize patients requiring endotracheal intubation into intervention (apneic oxygenation) and control (no apneic oxygenation). We will measure the lowest arterial oxygen saturation from the start of the intubation procedure through 2 minutes after intubation is complete.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Apneic Oxygenation | Experimental | Other: Apneic oxygenation during endotracheal intubationParticipants receiving apneic oxygenation |
| No Apneic Oxygenation | No intervention | –Participants not receiving apneic oxygenation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The inclusion criteria for our study will include patients 18 years or older who require emergent endotracheal intubation utilizing rapid sequence intubation (RSI) in the Emergency Department with first attempt taken by a resident or attending physician working in the emergency department. This includes Emergency Medicine attending physicians and residents as well as non-Emergency Medicine rotators (e.g.., Internal Medicine residents who are rotating through the Emergency Department).
Key exclusion criteria (1 listed)
- Exclusion criteria include patients who are in cardiac arrest, or if the patient received any positive pressure ventilation (i.e, BPAP, CPAP, BVM) in the emergency department before RSI.
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 |
|---|---|---|
| Apneic oxygenation during endotracheal intubationProviding oxygenation through nasal cannula during the apneic phase of endotracheal intubation. | Other | Apneic Oxygenation |
Primary outcome
Lowest oxygen saturation overall
Time frame: Time between neuromuscular blockade and 2 minutes after completion of endotracheal intubation
Lowest oxygen saturation between overall control and intervention groups
14 secondary outcomes
Lowest oxygen saturation precipitous intubations
Time frame: Time between neuromuscular blockade and 2 minutes after completion of endotracheal intubation
Lowest oxygen saturation pre-oxygenation
Time frame: Time between neuromuscular blockade and 2 minutes after completion of endotracheal intubation
Difference in baseline and final oxygen saturation
Time frame: Decision to intubate through 2 minutes after completion of endotracheal intubation
Difference in oxygen saturation before and after apneic period
Time frame: Initiation of neuromuscular blockade through 2 minutes after completion of endotracheal intubation
Desaturation
Time frame: Initiation of neuromuscular blockade through 2 minutes after completion of endotracheal intubation
number of attempts
Time frame: From first attempt at intubation through completion of endotracheal intubation procedure, approximately 2 minutes.
Need for second operator
Time frame: From first attempt at intubation through completion of endotracheal intubation procedure, approximately 2 minutes.
Need for additional intubating equipment
Time frame: From first attempt at intubation through completion of endotracheal intubation procedure, approximately 2 minutes.
Esophageal intubations
Time frame: From first attempt at intubation through entire ED stay, approximately 6 hours.
Procedural hypotension
Time frame: Initiation of neuromuscular blockade to 2 minutes after completion of endotracheal intubation
Aspiration
Time frame: Within 24 hours after intubation procedure was complete
Hospital length of stay
Time frame: Up to 28 days after intubation
Number of days intubated
Time frame: Up to 28 days after intubation
In-hospital mortality
Time frame: Up to 28 days after intubation
Results and safety
The study was stopped early (reason given: Could not enroll enough patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2020.
- 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. This study is not recruiting at the moment.
Ilya Ostrovsky, MD principal investigator
Rutgers, The State University of New Jersey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Apneic oxygenation during endotracheal intubation in people with Apneic Oxygenation and Endotracheal Intubation, run by Rutgers, The State University of New Jersey 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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 25 Mar 2020. 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 was stopped early (reason given: Could not enroll enough patients). Results are not available in the source record.
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?
Lowest oxygen saturation overall (time frame: Time between neuromuscular blockade and 2 minutes after completion of endotracheal intubation). 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 25 Mar 2020.