Investigating the time‐lapsed effects of rigid cervical collars on the dimensions of the internal jugular vein

Protocol advocates the use of rigid cervical collars (RCCs) in head trauma patients as they are at risk of concomitant cervical spine injury. Literature has shown RCCs to be a potential cause of venous outflow obstruction, changing internal jugular vein (IJV) cross‐sectional area (CSA), and raising intracranial pressure (ICP). This study aims to investigate the effects of applying a RCC, for a period of four hours, on the dimensions of the IJV, in healthy participants. Seventeen participants (nine male, eight female) took part in this study. Circumference and CSAs of the IJV were measured bilaterally by a single observer using a GE LOGIQ e ultrasound system. Measurements were taken pre‐RCC application, immediately after, every hour over four hours, and five minutes postcollar removal. The CSA of the IJV was 8.3 ±6.0 mm2 pre‐RCC application. The CSA of the IJV doubled (18.92 ±10.55 mm2) after four hours and decreased back to 9.36 ±6.8 mm2 five minutes postcollar removal. The circumference of the IJV was 17.29 ±6.03 mm pre‐RCC application, increasing to 20.34 ±5.59 mm by the end of the fourth hour and returning to 16.14 ±5.16 mm five minutes postcollar removal. Related‐samples Friedman's ANOVA test showed statistically significant differences for both left and right CSAs and circumferences of the IJV measured across the four hours (P‐value<0.05). Ultrasound assessment of CSA of the IJV may correlate with changes in ICP. Further studies may provide insight into the effects of collar design, and guide future trauma protocol to minimize intracranial pressure fluctuations. Clin. Anat. 32:196–200, 2019

The unrestricted global effort to complete the COOL trial

Background Severe complicated intra-abdominal sepsis (SCIAS) has an increasing incidence with mortality rates over 80% in some settings. Mortality typically results from disruption of the gastrointestinal tract, progressive and self-perpetuating bio-mediator generation, systemic inflammation, and multiple organ failure. A further therapeutic option may be open abdomen (OA) management with negative peritoneal pressure therapy (NPPT) to remove inflammatory ascites and attenuate the systemic damage from SCIAS, although there are definite risks of leaving the abdomen open whenever it might possibly be closed. This potential therapeutic paradigm is the rationale being assessed in the Closed Or Open after Laparotomy (COOL trial) (https://clinicaltrials.gov/ct2/show/NCT03163095). Initially, the COOL trial received Industry sponsorship; however, this funding mandated the use of a specific trademarked and expensive NPPT device in half of the patients allocated to the intervention (open) arm. In August 2022, the 3 M/Acelity Corporation without consultation but within the terms of the contract canceled the financial support of the trial. Although creating financial difficulty, there is now no restriction on specific NPPT devices and removing a cost-prohibitive intervention creates an opportunity to expand the COOL trial to a truly global basis. This document describes the evolution of the COOL trial, with a focus on future opportunities for global growth of the study.Methods The COOL trial is the largest prospective randomized controlled trial examining the random allocation of SCIAS patients intra-operatively to either formal closure of the fascia or the use of the OA with an application of an NPPT dressing. Patients are eligible if they have free uncontained intraperitoneal contamination and physiologic derangements exemplified by septic shock OR severely adverse predicted clinical outcomes. The primary outcome is intended to definitively inform global practice by conclusively evaluating 90-day survival. Initial recruitment has been lower than hoped but satisfactory, and the COOL steering committee and trial investigators intend with increased global support to continue enrollment until recruitment ensures a definitive answer.Discussion OA is mandated in many cases of SCIAS such as the risk of abdominal compartment syndrome associated with closure, or a planned second look as for example part of "damage control"; however, improved source control (locally and systemically) is the most uncertain indication for an OA. The COOL trial seeks to expand potential sites and proceed with the evaluation of NPPT agnostic to device, to properly examine the hypothesis that this treatment attenuates systemic damage and improves survival. This approach will not affect internal validity and should improve the external validity of any observed results of the intervention. Trial registration: National Institutes of Health (https://clinicaltrials.gov/ct2/show/NCT03163095). Keywords Intraperitoneal sepsis, Septic shock, Peritonitis, Open abdomen, Multiple organ dysfunction, Laparotomy, Randomized controlled trial, Global healthPeer reviewe