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 ).

Active Negative Pressure Peritoneal Therapy After Abbreviated Laparotomy: The Intraperitoneal Vacuum Randomized Controlled Trial.

OBJECTIVE: To determine whether active negative pressure peritoneal therapy with the ABThera temporary abdominal closure device reduces systemic inflammation after abbreviated laparotomy. BACKGROUND: Excessive systemic inflammation after abdominal injury or intra-abdominal sepsis is associated with poor outcomes. METHODS: We conducted a single-center, randomized controlled trial. Forty-five adults with abdominal injury (46.7%) or intra-abdominal sepsis (52.3%) were randomly allocated to the ABThera (n = 23) or Barker's vacuum pack (n = 22). On study days 1, 2, 3, 7, and 28, blood and peritoneal fluid were collected. The primary endpoint was the difference in the plasma concentration of interleukin-6 (IL-6) 24 and 48 hours after temporary abdominal closure application. RESULTS: There was a significantly lower peritoneal fluid drainage from the ABThera at 48 hours after randomization. Despite this, there was no difference in plasma concentration of IL-6 at baseline versus 24 (P = 0.52) or 48 hours (P = 0.82) between the groups. There was also no significant intergroup difference in the plasma concentrations of IL-1ß, -8, -10, or -12 p70 or tumor necrosis factor α between these time points. The cumulative incidence of primary fascial closure at 90 days was similar between groups (hazard ratio, 1.6; 95% confidence interval, 0.82-3.0; P = 0.17). However, 90-day mortality was improved in the ABThera group (hazard ratio, 0.32; 95% confidence interval, 0.11-0.93; P = 0.04). CONCLUSIONS: This trial observed a survival difference between patients randomized to the ABThera versus Barker's vacuum pack that did not seem to be mediated by an improvement in peritoneal fluid drainage, fascial closure rates, or markers of systemic inflammation. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT01355094.

Does trauma team activation associate with the time to CT scan for those suspected of serious head injuries?

BACKGROUND: Traumatic brain injury (TBI) constitutes the leading cause of posttraumatic mortality. Practically, the major interventions required to treat TBI predicate expedited transfer to CT after excluding other immediately life-threatening conditions. At our center, trauma responses variably consist of either full trauma activation (FTA) including an attending trauma surgeon or a non-trauma team response (NTTR). We sought to explore whether FTAs expedited the time to CT head (TTCTH). METHODS: Retrospective review of augmented demographics of 88 serious head injuries identified from a Regional Trauma Registry within one year at a level I trauma center. The inclusion criteria consisted of a diagnosis of head injury recorded as intubated or GCS < 13; and CT-head scanning after arriving the emergency department. Data was analyzed using STATA. RESULTS: There were 58 FTAs and 30 NTTRs; 86% of FTAs and 17% of NTTRs were intubated prehospital out of 101 charts reviewed in detail; 13 were excluded due to missing data. Although FTAs were more seriously injured (median ISS 29, MAIS head 19, GCS score at scene 6.0), NTTRs were also severely injured (median ISS 25, MAIS head 21, GCS at scene 10) and older (median 54 vs. 26 years). Median TTCTH was double without dedicated FTA (median 50 vs. 26 minutes, p < 0.001), despite similar justifiable delays (53% NTTR, 52% FTA). Without FTA, most delays (69%) were for emergency intubation. TTCTH after securing the airway was longer for NTTR group (median 38 vs. 26 minutes, p =0.0013). Even with no requirements for ED interventions, TTCTH for FTA was less than half versus NTTR (25 vs. 61 minutes, p =0.0013). Multivariate regression analysis indicated age and FTA with an attending surgeon as significant predictors of TTCTH, although the majority of variability in TTCTH was not explained by these two variables (R² = 0.33). CONCLUSION: Full trauma activations involving attending trauma surgeons were quicker at transferring serious head injury patients to CT. Patients with FTA were younger and more seriously injured. Discerning the reasons for delays to CT should be used to refine protocols aimed at minimizing unnecessary delays and enhancing workforce efficiency and clinical outcome.

Help is in your pocket: the potential accuracy of smartphone- and laptop-based remotely guided resuscitative telesonography.

BACKGROUND: Ultrasound (US) examination has many uses in resuscitation, but to use it to its full effectiveness typically requires a trained and proficient user. We sought to use information technology advances to remotely guide US-naive examiners (UNEs) using a portable battery-powered tele-US system mentored using either a smartphone or laptop computer. MATERIALS AND METHODS: A cohort of UNEs (5 tactical emergency medicine technicians, 10 ski-patrollers, and 4 nurses) was guided to perform partial or complete Extended Focused Assessment with Sonography of Trauma (EFAST) examinations on both a healthy volunteer and on a US phantom, while being mentored by a remote examiner who viewed the US images over either an iPhone(®) (Apple, Cupertino, CA) or a laptop computer with an inlaid depiction of the US probe and the "patient," derived from a videocamera mounted on the UNE's head. Examinations were recorded as still images and over-read from a Web site by seven expert reviewers (ERs) (three surgeons, two emergentologists, and two radiologists). Examination goals were to identify lung sliding (LS) documented by color power Doppler (CPD) in the human and to identify intraperitoneal (IP) fluid in the phantom. RESULTS: All UNEs were successfully mentored to easily and clearly identify both LS (19 determinations) and IP fluid (14 determinations), as assessed in real time by the remote mentor. ERs confirmed IP fluid in 95 of 98 determinations (97%), with 100% of ERs perceiving clinical utility for the abdominal Focused Assessment with Sonography of Trauma. Based on single still CPD images, 70% of ERs agreed on the presence or absence of LS. In 16 out of 19 cases, over 70% of the ERs felt the EFAST exam was clinically useful. CONCLUSIONS: UNEs can confidently be guided to obtain critical findings using simple information technology resources, based on the receiving/transmitting device found in most trauma surgeons' pocket or briefcase. Global US mentoring requires only Internet connectivity and initiative.

The feasibility of nurse practitioner-performed, telementored lung telesonography with remote physician guidance - 'a remote virtual mentor'.

BACKGROUND: Point-of-care ultrasound (POC-US) use is increasingly common as equipment costs decrease and availability increases. Despite the utility of POC-US in trained hands, there are many situations wherein patients could benefit from the added safety of POC-US guidance, yet trained users are unavailable. We therefore hypothesized that currently available and economic 'off-the-shelf' technologies could facilitate remote mentoring of a nurse practitioner (NP) to assess for recurrent pneumothoraces (PTXs) after chest tube removal. METHODS: The simple remote telementored ultrasound system consisted of a handheld ultrasound machine, head-mounted video camera, microphone, and software on a laptop computer. The video output of the handheld ultrasound machine and a macroscopic view of the NP's hands were displayed to a remote trauma surgeon mentor. The mentor instructed the NP on probe position and US machine settings and provided real-time guidance and image interpretation via encrypted video conferencing software using an Internet service provider. Thirteen pleural exams after chest tube removal were conducted. RESULTS: Thirteen patients (26 lung fields) were examined. The remote exam was possible in all cases with good connectivity including one trans-Atlantic interpretation. Compared to the subsequent upright chest radiograph, there were 4 true-positive remotely diagnosed PTXs, 2 false-negative diagnoses, and 20 true-negative diagnoses for 66% sensitivity, 100% specificity, and 92% accuracy for remotely guided chest examination. CONCLUSIONS: Remotely guiding a NP to perform thoracic ultrasound examinations after tube thoracostomy removal can be simply and effectively performed over encrypted commercial software using low-cost hardware. As informatics constantly improves, mentored remote examinations may further empower clinical care providers in austere settings.

Efficacy and safety of active negative pressure peritoneal therapy for reducing the systemic inflammatory response after damage control laparotomy (the Intra-peritoneal Vacuum Trial): study protocol for a randomized controlled trial.

BACKGROUND: Damage control laparotomy, or abbreviated initial laparotomy followed by temporary abdominal closure (TAC), intensive care unit resuscitation, and planned re-laparotomy, is frequently used to manage intra-abdominal bleeding and contamination among critically ill or injured adults. Animal data suggest that TAC techniques that employ negative pressure to the peritoneal cavity may reduce the systemic inflammatory response and associated organ injury. The primary objective of this study is to determine if use of a TAC dressing that affords active negative pressure peritoneal therapy, the ABThera Open Abdomen Negative Pressure Therapy System, reduces the extent of the systemic inflammatory response after damage control laparotomy for intra-abdominal sepsis or injury as compared to a commonly used TAC method that provides potentially less efficient peritoneal negative pressure, the Barker's vacuum pack. METHODS/DESIGN: The Intra-peritoneal Vacuum Trial will be a single-center, randomized controlled trial. Adults will be intraoperatively allocated to TAC with either the ABThera or Barker's vacuum pack after the decision has been made by the attending surgeon to perform a damage control laparotomy. The study will use variable block size randomization. On study days 1, 2, 3, 7, and 28, blood will be collected. Whenever possible, peritoneal fluid will also be collected at these time points from the patient's abdomen or TAC device. Luminex technology will be used to quantify the concentrations of 65 mediators relevant to the inflammatory response in peritoneal fluid and plasma. The primary endpoint is the difference in the plasma concentration of the pro-inflammatory cytokine IL-6 at 24 and 48 h after TAC dressing application. Secondary endpoints include the differential effects of these dressings on the systemic concentration of other pro-inflammatory cytokines, collective peritoneal and systemic inflammatory mediator profiles, postoperative fluid balance, intra-abdominal pressure, and several patient-important outcomes, including organ dysfunction measures and mortality. DISCUSSION: Results from this study will improve understanding of the effect of active negative pressure peritoneal therapy after damage control laparotomy on the inflammatory response. It will also gather necessary pilot information needed to inform design of a multicenter trial comparing clinical outcomes among patients randomized to TAC with the ABThera versus Barker's vacuum pack. TRIAL REGISTRATION: ClinicalTrials.gov identifier http://www.clicaltrials.gov/ct2/show/NCT01355094.

Occult pneumothoraces in critical care: a prospective multicenter randomized controlled trial of pleural drainage for mechanically ventilated trauma patients with occult pneumothoraces.

BACKGROUND: Patients with an occult pneumothoraces (OPTXs) may be at risk of tension pneumothoraces (TPTXs) without drainage or pleural drainage complications if treated. METHODS: Adults with traumatic OPTXs and requiring positive-pressure ventilation (PPV) were randomized to pleural drainage or observation (one side only enrolled if bilateral). All subsequent care and method of pleural drainage was per attending physician discretion. The primary outcome was a composite of respiratory distress (RD) (need for urgent pleural drainage, acute/sustained increases in O2 requirements, ventilator dysynchrony, and/or charted respiratory events). RESULTS: Ninety severely injured patients (mean [SD], Injury Severity Score [ISS], 33 [11]) were studied at four centers: Calgary (55), Toronto (27), Quebec (6), and Sherbrooke (3). Forty were randomized to tube thoracostomy, and 50 were randomized to observation. The risk of RD was similar between the observation and tube thoracostomy groups (relative risk, 0.71; 95% confidence interval, 0.40-1.27). There was no difference in mortality or intensive care unit (ICU), ventilator, or hospital days between groups. In those observed, 20% required subsequent pleural drainage (40% PTX progression, 60% pleural fluid, and 20% other). One observed patient (2%) undergoing PPV at enrollment had a TPTX, which was treated with urgent tube thoracostomy without sequelae. Drainage complications occurred in 15% of those randomized to drainage, while suboptimal tube thoracostomy position occurred in an additional 15%. There were three times (24% vs. 8%) more failures and more RDs (p = 0.01) among those observed with OPTXs requiring sustained PPV versus just for an operation, which increases threefold after a week in the ICU (p = 0.07). CONCLUSION: Our results suggest that OPTXs may be safely observed in hemodynamically stable patients undergoing PPV just for an operation, although one third of those requiring a week or more of ICU care received drainage, and TPTXs still occur. Complications of pleural drainage remain unacceptably high, and future work should attempt to delineate specific factors among those observed that warrant prophylactic drainage. LEVEL OF EVIDENCE: Therapeutic study, level III.

How to set up a low cost tele-ultrasound capable videoconferencing system with wide applicability.

BACKGROUND: Worldwide ultrasound equipment accessibility is at an all-time high, as technology improves and costs decrease. Ensuring that patients benefit from more accurate resuscitation and diagnoses from a user-dependent technology, such as ultrasound, requires accurate examination, typically entailing significant training. Remote tele-mentored ultrasound (RTUS) examination is, however, a technique pioneered in space medicine that has increased applicability on earth. We, thus, sought to create and demonstrate a cost-minimal approach and system with potentially global applicability. METHODS: The cost-minimal RTUS system was constructed by utilizing a standard off-the-shelf laptop computer that connected to the internet through an internal wireless receiver and/or was tethered through a smartphone. A number of portable hand-held ultrasound devices were digitally streamed into the laptop utilizing a video converter. Both the ultrasound video and the output of a head-mounted video camera were transmitted over freely available Voice Over Internet Protocol (VOIP) software to remote experts who could receive and communicate using any mobile device (computer, tablet, or smartphone) that could access secure VOIP transmissions from the internet. RESULTS: The RTUS system allowed real-time mentored tele-ultrasound to be conducted from a variety of settings that were inside buildings, outside on mountainsides, and even within aircraft in flight all unified by the simple capability of receiving and transmitting VOIP transmissions. . Numerous types of ultrasound examinations were conducted such as abdominal and thoracic examinations with a variety of users mentored who had previous skills ranging from none to expert. Internet connectivity was rarely a limiting factor, with competing logistical and scheduling demands of the participants predominating. CONCLUSIONS: RTUS examinations can educate and guide point of care clinical providers to enhance their use of ultrasound. The scope of the examinations conducted is limited only by the time available and the criticality of the subject being examined. As internet connectivity will only improve worldwide, future developments need to focus on the human factors to optimize tele-sonographic interactions.

Admission base deficit and lactate levels in Canadian patients with blunt trauma: are they useful markers of mortality?

BACKGROUND: Elevated base deficit (BD) and lactate levels at admission in patients with injury have been shown to be associated with increased mortality. This relationship is undefined in the Canadian experience. The goal of this study was to define the association between arterial blood gas (ABG) values at admission and mortality for Canadians with severe blunt injury. METHODS: A retrospective review of 3,000 consecutive adult major trauma admissions (Injury Severity Score, ≥ 12) to a Canadian academic tertiary care referral center was performed. ABG values at the time of arrival were analyzed with respect to associated mortality and length of stay. RESULTS: A total of 2,269 patients (76%) had complete data available for analysis. After exclusion of patients who sustained a penetrating injury or were admitted for minor falls (ground levels or low height), 445 had an ABG drawn within 2 hours of arrival. Patients who died displayed a higher median lactate (3.6 vs. 2.2, p < 0.0001), a worse median BD (-10 vs. -5, p < 0.0001), and a lower pH (7.23 vs. 7.31, p < 0.0001) at arrival compared with those of survivors. A statistically significant association was also observed between lactate and BD values at arrival and both mortality and length of stay (p < 0.0001). CONCLUSION: Despite population differences, ABGs at admission in Canadian patients with blunt trauma accurately reflect mortality in a similar manner to the previously published literature. Survival curves with lactate and BD values at arrival should be available to all clinicians within their individual trauma centers for both acute care and quality assurance. LEVEL OF EVIDENCE: Prognostic study, level III.

The song remains the same although the instruments are changing: complications following selective non-operative management of blunt spleen trauma: a retrospective review of patients at a level I trauma centre from 1996 to 2007.

BACKGROUND: Despite a widespread shift to selective non-operative management (SNOM) for blunt splenic trauma, there remains uncertainty regarding the role of adjuncts such as interventional radiological techniques, the need for follow-up imaging, and the incidence of long-term complications. We evaluated the success of SNOM (including splenic artery embolization, SAE) for the management of blunt splenic injuries in severely injured patients. METHODS: Retrospective review (1996-2007) of the Alberta Trauma Registry and health records for blunt splenic trauma patients, aged 18 and older, with injury severity scores of 12 or greater, admitted to the Foothills Medical Centre. RESULTS: Among 538 eligible patients, 150 (26%) underwent early operative intervention. The proportion of patients managed by SNOM rose from 50 to 78% over the study period, with an overall success rate of SNOM of 87%, while injury acuity remained unchanged over time. Among SNOM failures, 65% underwent surgery within 24 hours of admission. Splenic arterial embolization (SAE) was used in only 7% of patients managed non-operatively, although at least 21% of failed SNOM had contrast extravasation potentially amenable to SAE. Among Calgary residents undergoing SNOM, hospital readmission within six months was required in three (2%), all of whom who required emergent intervention (splenectomy 2, SAE 1) and in whom none had post-discharge follow-up imaging. Overall, the use of post-discharge follow-up CT imaging was low following SNOM (10%), and thus no CT images identified occult hemorrhage or pseudoaneurysm. We observed seven cases of delayed splenic rupture in our population which occurred from five days to two months following initial injury. Three of these occurred in the post-discharge period requiring readmission and intervention. CONCLUSIONS: SNOM was the initial treatment strategy for most patients with blunt splenic trauma with 13% requiring subsequent operative intervention intended for the spleen. Cases of delayed splenic rupture occurred up to two months following initial injury. The low use of both follow-up imaging and SAE make assessment of the utility of these adjuncts difficult and adherence to formalized protocols will be required to fully assess the benefit of multi-modality management strategies.

Management of incidental findings in the trauma patient: is the trauma team a primary care provider as well?

BACKGROUND: Computed tomographic scanning and tertiary surveys have resulted in an increase of incidental findings (IFs) unrelated to the trauma. The goals were to (1) characterize the frequency and nature of IFs and (2) explore their management by a trauma nurse practitioner. METHODS: A prospective log of IFs and follow-up details was maintained by a trauma nurse practitioner. Supplemental data were obtained through hospital databases. RESULTS: A total of 404 trauma patients were screened for IFs over a 6-month period, and 68% had IFs of varying severity. CONCLUSION: IFs are frequent in trauma. Appropriate management and follow-up is a major commitment that can be well managed by a trauma nurse practitioner.

Weather and chinook winds in relation to spontaneous pneumothoraces.

BACKGROUND: Spontaneous pneumothorax (SP) results from the rupture of blebs or emphysematous bullae. Rapid changes in weather may precipitate this process. The city of Calgary is well suited to examine the effects of weather and specifically the rapid changes in weather associated with a chinook event and the occurrence of SP. METHODS: We performed a retrospective chart review of all cases of SP in the Calgary Health Region from 2001 to 2005. We obtained local hourly weather data over the same period from Environment Canada. We then compared the rates of SP on chinook and nonchinook days. Further, we compared mean daily temperature, humidity, wind speed and atmospheric pressure on chinook and nonchinook days. RESULTS: In all, 220 SP events from 149 patients occurred during the 4.5-year study period. There was no significant difference in the rate of SP on chinook days versus nonchinook days (p = 0.80). Similarly, there was no significant difference in the rate of SP in each of the 4 seasons (p = 0.30). We observed significantly higher average wind speed and lower mean atmospheric pressure on days with SP versus days without (p = 0.009, p = 0.020, respectively). There was no difference in mean temperature or mean relative humidity when comparing days with SP versus days without. CONCLUSION: We found no association between SP and chinook events. We observed significantly higher wind speeds and lower atmospheric pressures on days with SP versus days without.