Ethical Dilemmas in Clinical Trials Involving Pregnant Women

Date: July 21, 2023 Reference: Prekker et al. Video versus Direct Laryngoscopy for Tracheal Intubation of Critically Ill Adults. NEJM 2023 Guest Skeptic: Dr. Jeff Jarvis is the Chief Medical Officer and System Medical Director for the Metropolitan Area EMS Authority in Fort Worth, Texas, also known as MedStar. He is board certified in both Emergency Medicine and Emergency Medical Services. Jeff discusses the application of research in EMS on his podcast The EMS Lighthouse Project. Case: You are an emergency physician caring for a 65-year-old male with a history of hypertension and diabetes who presented with altered mental status, fever, and labored breathing. You’ve found that he is septic and in respiratory failure and needs intubation. Your assessment is that the patient will likely be a physiologically, but not anatomically, difficult airway. You’ve assured appropriate physiologic optimization and pharmacologic preparation and are ready to intubate. Should you go with video or direct laryngoscope? Background: We have looked at this issue of intubation multiple times on the SGEM. The most recent discussion was about the use of etomidate as an induction agent (SGEM#405). The conclusion from that episode was it’s still uncertain if using etomidate decreases the patient-oriented outcome of survival with good neurologic function in critically ill patients requiring emergent endotracheal intubation. Missy Carter The SGEM has also covered prehospital intubation using supraglottic devices for out-of-hospital cardiac arrests (OCHAs) with PA Missy Carter (SGEM#247 and SGEM#396). The take home message from those two episodes was that the airway is less important in adult OHCAs. We should focus more on high-quality CPR and early defibrillation for shockable rhythms and less on type of supraglottic airway device. Chip Lange PA Using a bougie to increase the first pass success (FPS) rate was discussed on SGEM271. It showed the use of a bougie was associated with an increase in FPS. A hypothesized option of adding point of care ultrasound (POCUS) to our various methods of confirming correct placement of the endotracheal tube was covered on SGEM#249 with PA Chip Lange. We felt transtracheal sonography represents a potential fast and accurate way to help confirm endotracheal tube placement in conjunction with other methods. Intubation FPS is associated with fewer adverse events, most importantly hypoxia, hypotension, and cardiac arrest. Traditionally, intubation was performed using direct laryngoscopes (DL) in which the soft tissues of the airway were physically displaced allowing direct visualization of the larynx, epiglottis, and vocal cords followed by passage of an endotracheal tube. The challenging part of intubation using DL is usually visualization of the laryngeal structures while tube passage is relatively easy. Video laryngoscopes (VL) have been developed to improve the challenging part of DL, ie visualization. Literature and clinical experience demonstrate that visualization is typically improved with VL, however, tube passage can be more challenging because the laryngeal structures are indirectly visualized. The debate of DL vs VL goes back over a decade. We covered the issue with guest skeptic Dr. Steve Carroll on SGEM#75 (Video Killed Direct Laryngoscopy). That was an RCT from Baltimore Shock Trauma center comparing the two modalities. The primary outcome was no statistical difference in survival to hospital discharge between the two groups. The SGEM bottom line at the time was VL leads to the same outcome as DL in trauma patients.  VL takes longer to accomplish and may be associated with higher mortality in patients with severe head injuries, however this relationship will require more study to confirm. The literature comparing FPS between DL and VL is mixed with some trials, primarily earlier ones, demonstrated either no improvement with VL or superiority with DL, and others,