Intubation, IntratrachealNCT05505799
Community Medical Center, Continuous Quality Improvement Project, Rapid Sequence Intubation
A study testing Intubation Checklist in people with Intubation, Intratracheal and Rapid Sequence Induction and Intubation, run by Community Medical Center, Toms River, NJ at 1 site in United States.
Trial summary
To assess the ongoing continuous quality improvement of rapid sequence intubation in our emergency department. Ongoing assessment will address standardization of the process and protocol driven measures that will improve the overall quality of the intervention. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intubation, Intratracheal, Rapid Sequence Induction and Intubation, Checklist
- What is being tested?
- Intubation Checklist
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jul 2022to 30 Jun 2025
- 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
- Any patient undergoing endotracheal intubation in the Emergency department
Who cannot join
- Age < 18 years old
Trial locations and contacts
1 site in 1 country.
United States1 site
Community Medical Center
Toms River, New Jersey, 08755
About this study
To assess the ongoing continuous quality improvement of rapid sequence intubation in our emergency department. Ongoing assessment will address standardization of the process and protocol driven measures that will improve the overall quality of the intervention.
Read the detailed description
Continuous evaluation and improvement of airway performance in the Emergency Department (ED) is essential for achieving positive clinical outcomes and reducing the incidence of related adverse events. First-pass success (FPS) in Rapid Sequence Intubation (RSI) is the most commonly utilized metric for evaluation and allows for comparison across clinical environments. According to a variety of studies published over the last decade, including a large, multi-center systematic review and meta-analysis, the mean FPS rate (84%) has been used as an institutional benchmark for ED airway proficiency.
Unfortunately, many complications can arise during RSI, the incidence of which has remained high. These complications commonly lead to poor or life-threatening outcomes and include desaturation, hypotension, dysrhythmia, cardiac arrest, pneumothorax, dental trauma, and esophageal intubation. According to the 4th National Audit Project of the Royal College of Anesthetists, it was determined that 30% of patients in the ED and 60% of patients in the ICU experiencing an airway related incident, suffered brain damage or death. The number of failed intubation attempts (3+) has been directly correlated with the an increased development of complications. Thus, establishing effective methods of decreasing the occurrence of failed attempts will result in an immediate reduction of unintended issues.
To maximize FPS and increase the safety of the procedure, it is essential to develop a tool to maximize efficacy. The introduction of checklists as a process improvement tool has been identified as a successful strategy for improving the effectiveness and quality of procedures throughout healthcare. Integration of a checklist in the RSI procedure will help to increase FPS rates and act as a method to aid in continuous evaluation and improvement of overall airway performance.
Although many airway performance improvement studies exist, our institution is unique in that we are a new Emergency Medicine (EM) Residency program that will be comprised of only post-graduate year 1 (PGY1) and post-graduate year 2 (PGY2) EM residents at the commencement of data collection. Furthermore, our clinical skills training process involves an integrative approach, pioneered by our interdisciplinary team of educators. Continuous evaluation of FPS and the incidence of RSI-related complications will allow for assessment of not only our quality improvement initiative, but of our educational methodology as well. Overall, implementation of quality and performance improvement strategies can mitigate the occurrence of adverse events and lead to improved health outcomes for our patients. This is of paramount importance to us as providers and to our community as a whole.
- Being tested
- Intubation Checklist, Standard Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intubation ChecklistOther
A preprocedure checklist will be made available to clinicians, and they will be educated on proper use of the checklist
Standard CareOther
Clinicians will intubate as per their usual practice
| Study group | Role | What they receive |
|---|---|---|
| Preintervention | Active comparator | Normal clinician intubation process Receives: Other: Standard Care |
| Postintervention | Experimental | Clinician intubation process after implementation and clinician education with a procedural checklist Receives: Other: Intubation Checklist |
What is being measured
The primary outcome is the main question the study is designed to answer.
First Pass Success Rate
Proportion of intubations where the trachea is successfully intubated on the first attempt
Measured: At time of intubation
Secondary outcomes (11)
Aspiration rate
Proportion of intubations where patients suffer aspiration
Measured: At time of intubation
Cardiac arrest
Proportion of intubations where patients suffer cardiac arrest
Measured: At time of intubation
Cuff Leak
Proportion of intubations where the endotracheal tube experiences a cuff leak
Measured: At time of intubation
Dental trauma
Proportion of intubations where patients suffer dental trauma
Measured: At time of intubation
Dysrhythmia
Proportion of intubations where patients suffer dysrhythmia
Measured: At time of intubation
Esophageal intubation
Proportion of intubations where patients encounter esophageal intubation
Measured: At time of intubation
Unplanned extubation
Proportion of intubations where patients encounter an unplanned extubation
Measured: At time of intubation
Post procedural hypotension
Proportion of intubations where patients suffer hypotension in the immediate postprocedure period
Measured: At time of intubation
Hypoxemia
Proportion of intubations where patients suffer hypoxemia
Measured: At time of intubation
Laryngospasm
Proportion of intubations where patients suffer laryngospasm
Measured: At time of intubation
Mainstem intubation
Proportion of intubations where patients encounter a mainstem intubation
Measured: At time of intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2022
- Study start7 Jul 2022
- Primary completion30 Jun 2024
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Intubation, IntratrachealStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Before and After study of a Checklist Intervention
- Masking
- None (open label)
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Community Medical Center, Toms River, NJ
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Greg Neyman, Community Medical Center, Toms River, NJ
- Investigators
- Josesph Roarty, MD, Principal investigator, Robert Wood Johnson Barnabas Health Community Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05505799
- Sponsor's protocol ID
- 22-020
- Status last verified
- Feb 2024
- First submitted
- 16 Aug 2022
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sakles JC, Augustinovich CC, Patanwala AE, Pacheco GS, Mosier JM. Improvement in the Safety of Rapid Sequence Intubation in the Emergency Department with the Use of an Airway Continuous Quality Improvement Program. West J Emerg Med. 2019 Jul;20(4):610-618. doi: 10.5811/westjem.2019.4.42343. Epub 2019 Jun 3.
PubMed 31316700Turner JS, Bucca AW, Propst SL, Ellender TJ, Sarmiento EJ, Menard LM, Hunter BR. Association of Checklist Use in Endotracheal Intubation With Clinically Important Outcomes: A Systematic Review and Meta-analysis. JAMA Netw Open. 2020 Jul 1;3(7):e209278. doi: 10.1001/jamanetworkopen.2020.9278.
PubMed 32614424Park L, Zeng I, Brainard A. Systematic review and meta-analysis of first-pass success rates in emergency department intubation: Creating a benchmark for emergency airway care. Emerg Med Australas. 2017 Feb;29(1):40-47. doi: 10.1111/1742-6723.12704. Epub 2016 Oct 27.
PubMed 27785883Sakles JC, Chiu S, Mosier J, Walker C, Stolz U. The importance of first pass success when performing orotracheal intubation in the emergency department. Acad Emerg Med. 2013 Jan;20(1):71-8. doi: 10.1111/acem.12055.
PubMed 23574475Bernhard M, Becker TK, Gries A, Knapp J, Wenzel V. The First Shot Is Often the Best Shot: First-Pass Intubation Success in Emergency Airway Management. Anesth Analg. 2015 Nov;121(5):1389-93. doi: 10.1213/ANE.0000000000000891. No abstract available.
PubMed 26484464Sakles JC, Mosier JM, Patanwala AE, Arcaris B, Dicken JM. First Pass Success Without Hypoxemia Is Increased With the Use of Apneic Oxygenation During Rapid Sequence Intubation in the Emergency Department. Acad Emerg Med. 2016 Jun;23(6):703-10. doi: 10.1111/acem.12931. Epub 2016 May 13.
PubMed 26836712Gopinath B, Sachdeva S, Kumar A, Kumar G. Advancing emergency airway management by reducing intubation time at a high-volume academic emergency department. BMJ Open Qual. 2021 Jul;10(Suppl 1):e001448. doi: 10.1136/bmjoq-2021-001448.
PubMed 34344738Weingart SD, Levitan RM. Preoxygenation and prevention of desaturation during emergency airway management. Ann Emerg Med. 2012 Mar;59(3):165-75.e1. doi: 10.1016/j.annemergmed.2011.10.002. Epub 2011 Nov 3.
PubMed 22050948
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Medical Center, Continuous Quality Improvement Project, Rapid Sequence Intubation
- ClinicalTrials.gov ID
- NCT05505799
- Acronym / sponsor ID
- 22-020
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Community Medical Center, Toms River, NJUniversity, hospital or other
- Study start
- 7 Jul 2022 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 18 Aug 2022 (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.
To assess the ongoing continuous quality improvement of rapid sequence intubation in our emergency department. Ongoing assessment will address standardization of the process and protocol driven measures that will improve the overall quality of the intervention.
Detailed description
Continuous evaluation and improvement of airway performance in the Emergency Department (ED) is essential for achieving positive clinical outcomes and reducing the incidence of related adverse events. First-pass success (FPS) in Rapid Sequence Intubation (RSI) is the most commonly utilized metric for evaluation and allows for comparison across clinical environments. According to a variety of studies published over the last decade, including a large, multi-center systematic review and meta-analysis, the mean FPS rate (84%) has been used as an institutional benchmark for ED airway proficiency.
Unfortunately, many complications can arise during RSI, the incidence of which has remained high. These complications commonly lead to poor or life-threatening outcomes and include desaturation, hypotension, dysrhythmia, cardiac arrest, pneumothorax, dental trauma, and esophageal intubation. According to the 4th National Audit Project of the Royal College of Anesthetists, it was determined that 30% of patients in the ED and 60% of patients in the ICU experiencing an airway related incident, suffered brain damage or death. The number of failed intubation attempts (3+) has been directly correlated with the an increased development of complications. Thus, establishing effective methods of decreasing the occurrence of failed attempts will result in an immediate reduction of unintended issues.
To maximize FPS and increase the safety of the procedure, it is essential to develop a tool to maximize efficacy. The introduction of checklists as a process improvement tool has been identified as a successful strategy for improving the effectiveness and quality of procedures throughout healthcare. Integration of a checklist in the RSI procedure will help to increase FPS rates and act as a method to aid in continuous evaluation and improvement of overall airway performance.
Although many airway performance improvement studies exist, our institution is unique in that we are a new Emergency Medicine (EM) Residency program that will be comprised of only post-graduate year 1 (PGY1) and post-graduate year 2 (PGY2) EM residents at the commencement of data collection. Furthermore, our clinical skills training process involves an integrative approach, pioneered by our interdisciplinary team of educators. Continuous evaluation of FPS and the incidence of RSI-related complications will allow for assessment of not only our quality improvement initiative, but of our educational methodology as well. Overall, implementation of quality and performance improvement strategies can mitigate the occurrence of adverse events and lead to improved health outcomes for our patients. This is of paramount importance to us as providers and to our community as a whole.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Before and After study of a Checklist Intervention
| Arm | Type | Receives |
|---|---|---|
| Preintervention | Active comparator | Other: Standard CareNormal clinician intubation process |
| Postintervention | Experimental | Other: Intubation ChecklistClinician intubation process after implementation and clinician education with a procedural checklist |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any patient undergoing endotracheal intubation in the Emergency department
Key exclusion criteria (1 listed)
- Age < 18 years old
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 |
|---|---|---|
| Intubation ChecklistA preprocedure checklist will be made available to clinicians, and they will be educated on proper use of the checklist | Other | Postintervention |
| Standard CareClinicians will intubate as per their usual practice | Other | Preintervention |
Primary outcome
First Pass Success Rate
Time frame: At time of intubation
Proportion of intubations where the trachea is successfully intubated on the first attempt
11 secondary outcomes
Aspiration rate
Time frame: At time of intubation
Cardiac arrest
Time frame: At time of intubation
Cuff Leak
Time frame: At time of intubation
Dental trauma
Time frame: At time of intubation
Dysrhythmia
Time frame: At time of intubation
Esophageal intubation
Time frame: At time of intubation
Unplanned extubation
Time frame: At time of intubation
Post procedural hypotension
Time frame: At time of intubation
Hypoxemia
Time frame: At time of intubation
Laryngospasm
Time frame: At time of intubation
Mainstem intubation
Time frame: At time of intubation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
- Background: PubMed 31316700Sakles JC, Augustinovich CC, Patanwala AE, Pacheco GS, Mosier JM. Improvement in the Safety of Rapid Sequence Intubation in the Emergency Department with the Use of an Airway Continuous Quality Improvement Program. West J Emerg Med. 2019 Jul;20(4):610-618. doi: 10.5811/westjem.2019.4.42343. Epub 2019 Jun 3.
- Background: PubMed 32614424Turner JS, Bucca AW, Propst SL, Ellender TJ, Sarmiento EJ, Menard LM, Hunter BR. Association of Checklist Use in Endotracheal Intubation With Clinically Important Outcomes: A Systematic Review and Meta-analysis. JAMA Netw Open. 2020 Jul 1;3(7):e209278. doi: 10.1001/jamanetworkopen.2020.9278.
- Background: PubMed 27785883Park L, Zeng I, Brainard A. Systematic review and meta-analysis of first-pass success rates in emergency department intubation: Creating a benchmark for emergency airway care. Emerg Med Australas. 2017 Feb;29(1):40-47. doi: 10.1111/1742-6723.12704. Epub 2016 Oct 27.
- Background: PubMed 23574475Sakles JC, Chiu S, Mosier J, Walker C, Stolz U. The importance of first pass success when performing orotracheal intubation in the emergency department. Acad Emerg Med. 2013 Jan;20(1):71-8. doi: 10.1111/acem.12055.
- Background: PubMed 26484464Bernhard M, Becker TK, Gries A, Knapp J, Wenzel V. The First Shot Is Often the Best Shot: First-Pass Intubation Success in Emergency Airway Management. Anesth Analg. 2015 Nov;121(5):1389-93. doi: 10.1213/ANE.0000000000000891. No abstract available.
- Background: PubMed 26836712Sakles JC, Mosier JM, Patanwala AE, Arcaris B, Dicken JM. First Pass Success Without Hypoxemia Is Increased With the Use of Apneic Oxygenation During Rapid Sequence Intubation in the Emergency Department. Acad Emerg Med. 2016 Jun;23(6):703-10. doi: 10.1111/acem.12931. Epub 2016 May 13.
- Background: PubMed 34344738Gopinath B, Sachdeva S, Kumar A, Kumar G. Advancing emergency airway management by reducing intubation time at a high-volume academic emergency department. BMJ Open Qual. 2021 Jul;10(Suppl 1):e001448. doi: 10.1136/bmjoq-2021-001448.
- Background: PubMed 22050948Weingart SD, Levitan RM. Preoxygenation and prevention of desaturation during emergency airway management. Ann Emerg Med. 2012 Mar;59(3):165-75.e1. doi: 10.1016/j.annemergmed.2011.10.002. Epub 2011 Nov 3.
- 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.
Josesph Roarty, MD principal investigator
Robert Wood Johnson Barnabas Health Community Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intubation Checklist in people with Intubation, Intratracheal and Rapid Sequence Induction and Intubation, run by Community Medical Center, Toms River, NJ 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: status not confirmed, as of the sponsor's last update on 12 Feb 2025. 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?
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?
First Pass Success Rate (time frame: At time of intubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05505799, which also lists 8 linked publications.
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 12 Feb 2025.