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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05505799
Other study ID # 22-020
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 7, 2022
Est. completion date June 30, 2024

Study information

Verified date February 2024
Source Community Medical Center, Toms River, NJ
Contact Josesph Roarty, MD
Phone 732-557-8185
Email Joseph.Roarty@rwjbh.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 700
Est. completion date June 30, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Any patient undergoing endotracheal intubation in the Emergency department Exclusion Criteria: - Age < 18 years old

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Intubation Checklist
A preprocedure checklist will be made available to clinicians, and they will be educated on proper use of the checklist
Standard Care
Clinicians will intubate as per their usual practice

Locations

Country Name City State
United States Community Medical Center Toms River New Jersey

Sponsors (1)

Lead Sponsor Collaborator
Community Medical Center, Toms River, NJ

Country where clinical trial is conducted

United States, 

References & Publications (8)

Bernhard 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. — View Citation

Gopinath 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. — View Citation

Park 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. — View Citation

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. — View Citation

Sakles 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. — View Citation

Sakles 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. — View Citation

Turner 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. Erratum In: JAMA Netw Open. 2020 Jul 1;3(7):e2016899. — View Citation

Weingart 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary First Pass Success Rate Proportion of intubations where the trachea is successfully intubated on the first attempt At time of intubation
Secondary Aspiration rate Proportion of intubations where patients suffer aspiration At time of intubation
Secondary Cardiac arrest Proportion of intubations where patients suffer cardiac arrest At time of intubation
Secondary Cuff Leak Proportion of intubations where the endotracheal tube experiences a cuff leak At time of intubation
Secondary Dental trauma Proportion of intubations where patients suffer dental trauma At time of intubation
Secondary Dysrhythmia Proportion of intubations where patients suffer dysrhythmia At time of intubation
Secondary Esophageal intubation Proportion of intubations where patients encounter esophageal intubation At time of intubation
Secondary Unplanned extubation Proportion of intubations where patients encounter an unplanned extubation At time of intubation
Secondary Post procedural hypotension Proportion of intubations where patients suffer hypotension in the immediate postprocedure period At time of intubation
Secondary Hypoxemia Proportion of intubations where patients suffer hypoxemia At time of intubation
Secondary Laryngospasm Proportion of intubations where patients suffer laryngospasm At time of intubation
Secondary Mainstem intubation Proportion of intubations where patients encounter a mainstem intubation At time of intubation
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