Intubation Checklist for Rapid Sequence Intubation

Overseen By Josesph Roarty, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Community Medical Center, Toms River, NJ

Disqualifiers: Age < 18 years

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve rapid sequence intubation, a medical procedure used to quickly secure a patient's airway in emergencies. The research focuses on standardizing this process to enhance its quality. Participants will experience either the usual intubation process or a new process using a checklist. Individuals undergoing endotracheal intubation (a tube placed into the windpipe) in the emergency department may be suitable for this trial. As an unphased trial, it offers participants the opportunity to contribute to the advancement of emergency medical procedures.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this protocol is safe for rapid sequence intubation?

Research shows that using a checklist during rapid sequence intubation (RSI) can enhance safety. Studies have found that a checklist increases doctors' success rates on their first attempt, reducing the risk of complications like low oxygen levels. Specifically, one study found that success rates on the first try improved from 90.9% to 93.3% with the checklist.

However, RSI still carries some risks. In some cases, about 15.9% of patients experienced issues such as low blood pressure or low oxygen levels. While these issues are important to consider, the checklist seems to help mitigate these risks.

Overall, the checklist improves the safety of RSI by enabling doctors to perform the procedure more effectively and reducing some common complications. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to improve the safety and effectiveness of rapid sequence intubation (RSI) by using a procedural checklist. Unlike the standard approach, which relies solely on the clinician's experience and judgment, this checklist provides a structured guide to ensure all critical steps are followed consistently. This method could lead to fewer complications and better patient outcomes during intubation, providing a significant advancement over traditional techniques.

What evidence suggests that this protocol is effective for rapid sequence intubation?

This trial will compare the intubation process before and after implementing a procedural checklist for Rapid Sequence Intubation (RSI). Studies have shown that a checklist for RSI can make the procedure safer and more effective. Research indicates that this checklist increases first-pass success (FPS), helping doctors succeed on the first try more often. One study found that before using the checklist, FPS was achieved 90.9% of the time, but this improved with the checklist. Additionally, the checklist reduces the chance of low oxygen levels during the procedure. Overall, the checklist makes RSI smoother and safer. ^{1 2 3 6 7}

Who Is on the Research Team?

Josesph Roarty, MD

Principal Investigator

Robert Wood Johnson Barnabas Health Community Medical Center

Are You a Good Fit for This Trial?

This trial is for any patient who needs an endotracheal intubation in the Emergency department. It's not open to individuals under 18 years old.

Inclusion Criteria

I have been intubated in the emergency department.

Exclusion Criteria

I am under 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preintervention

Normal clinician intubation process is observed and data is collected

4 weeks

Postintervention

Clinician intubation process after implementation and clinician education with a procedural checklist

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Rapid Sequence Intubation

Trial Overview The study is testing whether using a checklist during rapid sequence intubation improves the quality and standardization of care compared to the usual procedures without a checklist.

How Is the Trial Designed?

Group I: Postintervention Experimental Treatment 1 Intervention

Clinician intubation process after implementation and clinician education with a procedural checklist

Group II: Preintervention Active Control 1 Intervention

Normal clinician intubation process

Who Is Running the Clinical Trial?

Community Medical Center, Toms River, NJ

Lead Sponsor

Trials

6

Recruited

1,400+

Published Research Related to This Trial

A systematic review of 11 studies involving 3261 patients found that using airway checklists during endotracheal intubation did not significantly reduce mortality rates, indicating that checklists may not improve overall survival in critically ill patients.

However, checklist use was associated with a reduction in hypoxic events during intubation, suggesting that while they may not lower mortality, they could help prevent some complications related to oxygen deprivation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of Checklist Use in Endotracheal Intubation With Clinically Important Outcomes: A Systematic Review and Meta-analysis. Turner, JS., Bucca, AW., Propst, SL., et al.[2021]

The use of a novel peri-intubation checklist significantly reduced the rate of omitted tasks during simulated airway management scenarios, with a decrease from 45.7% in the control group to 13.5% in the checklist group, representing a 32.2% absolute difference.

While the checklist improved task completion, it also resulted in longer times to definitive airway management in the first two scenarios, indicating a trade-off between thoroughness and speed in emergency situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does utilization of an intubation safety checklist reduce omissions during simulated resuscitation scenarios: a multi-center randomized controlled trial. Forristal, C., Hayman, K., Smith, N., et al.[2021]

The Neonatal Intubation Checklist significantly improved the proficiency of neonatal intubation among transport teams, with proficiency scores increasing from 29 to 57 after using the checklist (P < .001).

Using the checklist also reduced the time to perform intubation from an average of 626 seconds to 479 seconds, demonstrating that safety and efficiency can be enhanced without prolonging the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and Testing of a Neonatal Intubation Checklist for an Air Medical Transport Team. Davidson, LA., Utarnachitt, RB., Mason, A., et al.[2019]

The safety of marketed drugs is a significant concern, as some commonly prescribed medications can lead to serious or life-threatening side effects in patients.

The ChEMBL resource will provide a curated drug safety data set, including toxicity classifications and black box warnings, which will be freely available and regularly updated to aid in drug safety research and discovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug Safety Data Curation and Modeling in ChEMBL: Boxed Warnings and Withdrawn Drugs. Hunter, FMI., Bento, AP., Bosc, N., et al.[2023]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38821706/

Implementation of a Rapid Sequence Intubation Checklist ... Our data suggest that when a difficult airway is identified, using the RSI checklist improves FPS, thereby reducing adverse events.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1067991X23003000

Implementation of a Rapid Sequence Intubation Checklist ... Our data suggest that the implementation of an RSI checklist may improve first-intubation success and reduce the incidence of peri-intubation hypoxia.

3. airmedicaljournal.com airmedicaljournal.com/article/S1067-991X(23)00300-0/abstract

Implementation of a Rapid Sequence Intubation Checklist ... Results. Ten thousand four hundred five intubations were attempted during the study. FPS was achieved in 90.9% of patients before RSI checklist ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8702256/

Sustained Improvement in the Performance of Rapid ... Improvements in RSI safety were sustained 5 years after a successful improvement initiative, with further improvement seen in several key processes.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05505799

Study Details | NCT05505799 | Community Medical Center ... First-pass success (FPS) in Rapid Sequence Intubation (RSI) is the most commonly utilized metric for evaluation and allows for comparison across clinical ...

6. emergencymed.org.il emergencymed.org.il/wp-content/uploads/2021/02/Safety-of-rapid-sequence-intubation.pdf

Safety of rapid sequence intubation in an emergency ... Results: Six hundred and fifty-five patients underwent RSI with FPS of 86.6%. Complications were reported in 15.9%, mainly hypotension (10.9%) and desaturation ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33565240/

Safety of rapid sequence intubation in an emergency ... Results: Six hundred and fifty-five patients underwent RSI with FPS of 86.6%. Complications were reported in 15.9%, mainly hypotension (10.9%) and desaturation ...