A Multicenter Randomized Trial of a Checklist for Endotracheal Intubation of Critically Ill Adults

Janz, David R.; Semler, Matthew W.; Joffe, Aaron M.; Casey, Jonathan D; Lentz, Robert J.; deBoisblanc, Bennett P.; Khan, Yasín A.; Santanilla, Jairo I.; Bentov, Itay; Rice, Todd W.; Creek, Grady P.; Haddock, Jody L.; Vonderhaar, Derek J; Lapinel, N.; Samant, Sneha D.; Paccione, Rose; Dischert, Kevin M; Majid-Moosa, Abdulla; Crespo, Joaquin; Fashho, Michael B.; Matthews, Daniel T.; Berg, Jeannette Zinggeler; Assad, Tufik R.; McKown, Andrew C.; Huerta, Luis E.; Kocurek, Emily G.; Halliday, Stephen; Kerchberger, V.E.; Merrick, Christopher; Warren, Melissa; Brown, Ryan M; Self, Wesley H.; Long, E T; Hembrador, Sheena; Teng, An; Seaburg, Luke; Hunt, Daniel; Bining, Garinder; Colletti, Ashley A.; Nowlin, Alexander; Madu, Nneka; Kooner, Preetma; Chang, Alan L.; Doan, Chau X.; Sunshine, Jacob; Tran, Anthony; Griffith, Matthew

doi:10.1016/j.chest.2017.08.1163

Cited by 67 publications

(117 citation statements)

References 25 publications

(29 reference statements)

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“…In contrast, in two studies where PICL was the only study intervention, no beneficial effect could be demonstrated . A large multicentre study where patients were randomised to either checklist or no checklist, Janz et al could not detect any significant difference in the incidence of deoxygenation, hypotension nor first pass success rate . Nor could Conroy et al detect any improvement in complication metrics after institution of a PICL in an emergency department .…”

Section: Discussionmentioning

confidence: 95%

“…Similarly, Kerrey et al reported a 17% decrease in the incidence of peri‐intubation desaturation following the introduction of an improvement initiative where PICL use was one of several interventions . In contrast, in two studies where PICL was the only study intervention, no beneficial effect could be demonstrated . A large multicentre study where patients were randomised to either checklist or no checklist, Janz et al could not detect any significant difference in the incidence of deoxygenation, hypotension nor first pass success rate .…”

Section: Discussionmentioning

confidence: 99%

“…Nevertheless, checklist methodology remains controversial as concerns have been raised that flawed, misapplied or poorly implemented checklists may lack benefit or even be detrimental to patient safety …”

Section: Introductionmentioning

confidence: 99%

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Checklists in pre‐hospital advanced airway management

Klingberg

Kornhall

Gryth

et al. 2019

Acta Anaesthesiol Scand

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Background In pre‐hospital care, pre‐intubation checklists (PICL) are widely implemented as a safety measure and guidelines support their use. However, the true value of PICL among experienced airway providers is unknown. This study aims to explore possible benefits and disadvantages of PICL in the pre‐hospital setting. Methods We performed a subgroup analysis of a prospective, observational, multicentre study on pre‐hospital advanced airway management in the Nordic countries between May 2015 and November 2016. The original trial was designed to investigate the success rates of pre‐hospital tracheal intubations and the incidence of complications. Our study limited inclusion to drug assisted intubations performed by anaesthesiologists. Intubation success rates and complication rates were plotted against checklist use. Results We analyzed 588 pre‐hospital intubations for medical and traumatic emergencies. Overall, checklists were used in 60.5% of instances. Applying checklists was associated with increased success at first and second intubation attempts. There was no significant difference in the overall success rates (99.4% and 99.1%). Oesophageal misplacement was more common in the No‐PICL group (2.2% vs 0.3%) but otherwise the incidence of airway related complications did not differ between the groups. Scene time was significantly shorter in the No‐PICL group (23.6 vs 27.5 minutes). Conclusion In this retrospective study, checklist use correlated with fewer attempts at intubation when securing the airway. Despite this, we found no association between checklist use and the overall TI success rate or the incidence of serious adverse events. Scene times were shorter without PICL.

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Section: Discussionmentioning

confidence: 95%

Section: Discussionmentioning

confidence: 99%

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Checklists in pre‐hospital advanced airway management

Klingberg

Kornhall

Gryth

et al. 2019

Acta Anaesthesiol Scand

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“…One possible explanation to this finding is that an OTI protocol is only a grade 2+ recommendations in French guidelines [7]. In addition, the usefulness of a checklist was challenged recently [25].…”

Section: Global Airway Managementmentioning

confidence: 99%

Nationwide survey on training and device utilization during tracheal intubation in French intensive care units

Martin¹,

Decamps²,

Seguin³

et al. 2020

Ann. Intensive Care

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Background: Intubation is a lifesaving procedure that is often performed in intensive care unit (ICU) patients, but leads to serious adverse events in 20-40% of cases. Recent trials aimed to provide guidance about which medications, devices, and modalities maximize patient safety. Videolaryngoscopes are being offered in an increasing range of options and used in broadening indications (from difficult to unremarkable intubation). The objective of this study was to describe intubation practices and device availability in French ICUs. Materials and methods:We conducted an online nationwide survey by emailing an anonymous 26-item questionnaire to physicians in French ICUs. A single questionnaire was sent to either the head or the intubation expert at each ICU.Results: Of 257 ICUs, 180 (70%) returned the completed questionnaire. The results showed that 43% of intubators were not fully proficient in intubation; among them, 18.8% had no intubation training or had received only basic training (lectures and observation at the bedside). Among the participating ICUs, 94.4% had a difficult intubation trolley, 74.5% an intubation protocol, 92.2% a capnography device (used routinely to check tube position in 69.3% of ICUs having the device), 91.6% a laryngeal mask, 97.2% front-of-neck access capabilities, and 76.6% a videolaryngoscope. In case of difficult intubation, 85.6% of ICUs used a bougie (154/180) and 7.8% switched to a videolaryngoscope (14/180). Use of a videolaryngoscope was reserved for difficult intubation in 84% of ICUs (154/180). Having a videolaryngoscope was significantly associated with having an intubation protocol (P = 0.043) and using capnography (P = 0.02). Airtraq ® was the most often used videolaryngoscope (39.3%), followed by McGrath ® Mac (36.9%) then by Glidescope ® (14.5%). Conclusion:Nearly half the intubators in French ICUs are not fully proficient with OTI. Access to modern training methods such as simulation is inadequate. Most ICUs own a videolaryngoscope, but reserve it for difficult intubations.

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“…Under WIC regulations the research must involve no more than minimal risk, meaning that the probability and magnitude of harm or discomfort anticipated in the research is not greater than encountered in routine medical examination and testing (21 CFR 50.3[k]) . WIC has been utilized for many prospective comparative effectiveness investigations comparing standards of care, such as medical devices or clinical protocols . WIC trials have not generally been used for comparative drug investigations, such as randomized, blinded drug intervention trials.…”

mentioning

confidence: 99%

Study Enrollment When “Preconsent” Is Utilized for a Randomized Clinical Trial of Two Treatments for Acute Agitation in the Emergency Department

Cole

Klein

Mullinax

et al. 2019

Academic Emergency Medicine

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Background: Acute agitation in the emergency department (ED) represents a danger to both patients and their caregivers. Medication is often needed, and few high-quality randomized trials have evaluated the optimal drugs for this vulnerable population. In the United States, as of 2017, randomized trials of drugs typically cannot be conducted under Waiver of Consent (46 CFR 45.116), and Exception From Informed Consent trials (21 CFR 50.24) are limited to life-threatening conditions, are onerous, and require filing an investigational new drug application with the FDA. We sought to conduct a randomized double-dummy trial of inhaled loxapine versus intramuscular haloperidol + lorazepam for acute agitation in the ED by obtaining consent in advance ("preconsent") in patients at risk of future agitation, allowing study drug administration up to 3 years later if the patient presented with acute agitation.Objective: We sought to report the successful enrollment rate of patients preconsented at an earlier ED visit for this trial.Methods: This was an analysis of patients age 18 to 64 with bipolar I disorder or schizophrenia preconsented for enrollment in the trial (clinicaltrials.gov, NCT02877108) conducted at a single urban academic center seeing approximately 60,000 patients per year. Eligible patients were assessed for capacity to consent by trained research associates, and informed consent was obtained at an ED visit for the possibility of administering drugs for agitation within the next 3 years. In the event the patient later presented to the ED and the attending physician deemed the patient required treatment for acute agitation, preconsent was confirmed and study drug would be administered.Results: Over 67 days, 1,461 patients were screened in the ED, 269 had bipolar I or schizophrenia, 194 of whom had a contraindication to inhaled loxapine leaving 75 eligible patients; preconsent was obtained in 43 patients. Four additional patients who had not preconsented were consented for the trial in real time (three by surrogate, one patient had capacity while agitated) resulting in a total of 47 consented patients. Of these 47, a total of 12 were later removed from the study: 10 patients had unrecognized exclusion criteria for inhaled

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A Multicenter Randomized Trial of a Checklist for Endotracheal Intubation of Critically Ill Adults

Abstract: ClinicalTrials.gov; No.: NCT02497729; URL: www.clinicaltrials.gov.

Cited by 67 publications

References 25 publications

Checklists in pre‐hospital advanced airway management

Checklists in pre‐hospital advanced airway management

Nationwide survey on training and device utilization during tracheal intubation in French intensive care units

Study Enrollment When “Preconsent” Is Utilized for a Randomized Clinical Trial of Two Treatments for Acute Agitation in the Emergency Department

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