The RAMER Reviews: The DEVICE Trial
By: Joseph Wu, DO
Edited by Timothy Khowong, MD, MSed
Background
Tracheal intubation is a common procedure that occurs in settings involving critically ill patients including the emergency department(ED) and in the intensive care unit (ICU). The two most common laryngoscopes used for intubation are the direct laryngoscope (DL) and the video laryngoscope (VL). Direct laryngoscopy was first described in 1895 by Alfred Kirstein followed by the creation of the video laryngoscope in 2001 by John Pacey nearly over 100 years later.[1,2] A direct laryngoscope consists of a handle, a blade, and a light source for which is used to displace the tongue and epiglottis so that the clinician can visualize the vocal cords through the mouth. A video laryngoscope includes the same components. However, at the end of the blade, there is a camera which projects the image of the vocal cords onto a screen, eliminating the requirement to visualize the cords through the mouth. Approximately 80% of tracheal intubations performed in the ED and ICU are performed with direct laryngoscopy.[3] Failure to intubate successfully has been associated with life threatening complications Prekker et al., in Video versus Direct Laryngoscopy for Tracheal Intubation of Critically Ill Adults aimed to evaluate if the use of VL compared to DL increases first pass success.
The Study
The DEVICE Trial was a multicenter, prospective, unblinded, parallel group trial that enrolled 1417 patients from 7 EDs and 10 ICUs. Initially powered for 2000 patients, the study was stopped early due to efficacy. The inclusion criteria included patients 18 years or older, patients undergoing orotracheal intubation, and patients within a participating unit. Prisoners, known pregnant patients, patients who were deemed by the clinician to need immediate intubation prior to randomization, and patients with clinician determination of contraindication to VL or DL were contraindicated were excluded. The primary outcome for this study was first pass success with a single insertion of a laryngoscope blade and endotracheal tube or bougie. The secondary outcomes including severe hypoxemia defined as lowest pulse oxygen reading of <80%, severe hypotension defined as systolic blood pressure <65 mmHg, cardiac arrest resulting in death, and cardiac arrest not resulting in death during time of induction and within two minutes of intubation.
In this study, the experimental group of VL had a first pass success rate of 85.1% with 600/705 patients and the control group of DL had a first pass success rate of 70.8% with 504/712 patients. There was no statistical significance in regards to the secondary outcomes. Once again, the study was stopped due to efficacy, implying that VL is far superior to DL. The strength of this study was that there was a large number of patients enrolled spanning multiple sites including the ED and the ICU, out of the 1420 enrolled, only 3 were excluded as they were found to be prisoners, and the patients had similar demographics in both groups. There were however a couple areas where bias could be introduced into the study. For example, the study was stopped early due to benefits, which could overestimate the benefits. The majority of intubations were done by residents and critical care fellows, which could limit its generalizability to other providers including attending physicians. In addition, a majority of the operators intubating patients in this study had more experience with VL compared to DL, introducing another area for bias.
Discussion
Since multiple attempts at intubation is associated with significant adverse events for patients, should we all just switch to VL and completely abandon DL? I personally, am a VL purist and believe that there is a limited role for DL in the modern day clinical practice especially with the advent of the standard geometry blade, which allows for both VL and DL without having to switch blades. However I understand that there may be resource limited EDs and ICUs without readily available VL. VL and DL are skills all on their own and should be trained for the rare occasion where VL is not available.
References
1. Myatra SN, Patwa A, Divatia JV. Videolaryngoscopy for all intubations: Is direct laryngoscopy obsolete? Indian J Anaesth. 2022 Mar;66(3):169-173. doi: 10.4103/ija.ija_234_22. Epub 2022 Mar 24. PMID: 35497693; PMCID: PMC9053891.
2. Pieters BM, Eindhoven GB, Acott C, van Zundert AA. Pioneers of laryngoscopy: indirect, direct and video laryngoscopy. Anaesth Intensive Care. 2015 Jul;43 Suppl:4-11. doi: 10.1177/0310057X150430S103. PMID: 26126070.
3. Prekker ME, Driver BE, Trent SA, Resnick-Ault D, Seitz K, Russell DW, Gandotra S, Gaillard JP, Gibbs KW, Latimer A, Whitson MR, Ghamande S, Vonderhaar DJ, Walco JP, Hansen SJ, Douglas IS, Barnes CR, Krishnamoorthy V, Bastman JJ, Lloyd BD, Robison SW, Palakshappa JA, Mitchell S, Page DB, White HD, Espinera A, Hughes C, Joffe AM, Herbert JT, Schauer SG, Long BJ, Imhoff B, Wang L, Rhoads JP, Womack KN, Janz D, Self WH, Rice TW, Ginde AA, Casey JD, Semler MW; DEVICE investigators and the Pragmatic Critical Care Research Group. DirEct versus VIdeo LaryngosCopE (DEVICE): protocol and statistical analysis plan for a randomised clinical trial in critically ill adults undergoing emergency tracheal intubation. BMJ Open. 2023 Jan 13;13(1):e068978. doi: 10.1136/bmjopen-2022-068978. PMID: 36639210; PMCID: PMC9843219.