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

700 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial aims to improve the safety and success of inserting breathing tubes in emergency patients by using a step-by-step checklist. The checklist helps medical staff follow all necessary steps, reducing mistakes and complications.

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 data supports the effectiveness of the treatment Rapid Sequence Intubation?

Research shows that using checklists during rapid sequence intubation (a quick method to insert a breathing tube) can improve the completion of critical steps and medication use, leading to better patient outcomes. ^{1 2 3 4 5}

Is rapid sequence intubation generally safe for humans?

Checklists for rapid sequence intubation (RSI) can help reduce complications by ensuring compliance with best practice guidelines, suggesting that RSI can be safer when these checklists are used. ^{3 6 7 8 9}

How is Rapid Sequence Intubation different from other treatments for airway management?

Rapid Sequence Intubation (RSI) is unique because it involves the simultaneous administration of a sedative and a paralytic to quickly secure the airway, minimizing the risk of aspiration. This approach is different from other airway management techniques that may not use both medications together or may take longer to establish a secure airway. ^{10 11 12 13 14}

Research Team

Josesph Roarty, MD

Principal Investigator

Robert Wood Johnson Barnabas Health Community Medical Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Association of Checklist Use in Endotracheal Intubation With Clinically Important Outcomes: A Systematic Review and Meta-analysis. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Development and Testing of a Neonatal Intubation Checklist for an Air Medical Transport Team. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Quality Evaluation of a Checklist for Intubation Preparation in Graduate Medical Education. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Effectiveness of interventions to improve medication use during rapid-sequence intubation in a pediatric emergency department. [2020]

5. Australia pubmed.ncbi.nlm.nih.gov

Safety of rapid sequence intubation in an emergency training network. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Introduction of a rapid sequence induction checklist and its effect on compliance to guidelines and complications. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Development and validation of the SURgical PAtient Safety System (SURPASS) checklist. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Drug Safety Data Curation and Modeling in ChEMBL: Boxed Warnings and Withdrawn Drugs. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Does utilization of an intubation safety checklist reduce omissions during simulated resuscitation scenarios: a multi-center randomized controlled trial. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Divergent Cyclization Reactions of Morita-Baylis-Hillman Carbonates of 2-Cyclohexenone and Isatylidene Malononitriles. [2015]

11. England pubmed.ncbi.nlm.nih.gov

Chemoselective synthesis of 5,4'-imidazolinyl spirobarbiturates via NBS-promoted cyclization of unsaturated barbiturates and amidines. [2022]

12. Netherlands pubmed.ncbi.nlm.nih.gov

Green chemistry approaches to the regioselective synthesis of spiro heterobicyclic rings using iodine as a new and efficient catalyst under solvent-free conditions. [2021]

13. England pubmed.ncbi.nlm.nih.gov

Insights into the unexpected chemoselectivity in Brønsted acid catalyzed cyclization of isatins with enaminones: convenient synthesis of pyrrolo[3,4-c]quinolin-1-ones and spirooxindoles. [2018]

14. England pubmed.ncbi.nlm.nih.gov

Stereoselective synthesis of CF3-containing spirocyclic-oxindoles using N-2,2,2-trifluoroethylisatin ketimines: an update. [2023]