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1. The unrestricted global effort to complete the COOL trial

Author

Kirkpatrick, A, Coccolini, F, Tolonen, M, Minor, S, Catena, F, Gois, E, Doig, C, Hill, M, Ansaloni, L, Chiarugi, M, Tartaglia, D, Ioannidis, O, Sugrue, M, Colak, E, Hameed, S, Lampela, H, Agnoletti, V, Mckee, J, Garraway, N, Sartelli, M, Ball, C, Parry, N, Voght, K, Julien, L, Kroeker, J, Roberts, D, Faris, P, Tiruta, C, Moore, E, Ammons, L, Anestiadou, E, Bendinelli, C, Bouliaris, K, Carroll, R, Ceresoli, M, Favi, F, Gurrado, A, Rezende-Neto, J, Isik, A, Cremonini, C, Strambi, S, Koukoulis, G, Testini, M, Trpcic, S, Pasculli, A, Picariello, E, Abu-Zidan, F, Adeyeye, A, Augustin, G, Alconchel, F, Altinel, Y, Hernandez Amin, L, Aranda-Narvaez, J, Baraket, O, Biffl, W, Baiocchi, G, Bonavina, L, Brisinda, G, Cardinali, L, Celotti, A, Chaouch, M, Chiarello, M, Costa, G, De'Angelis, N, De Manzini, N, Delibegovic, S, Di Saverio, S, De Simone, B, Dubuisson, V, Fransvea, P, Garulli, G, Giordano, A, Gomes, C, Hayati, F, Huang, J, Ibrahim, A, Huei, T, Jailani, R, Khan, M, Luna, A, Malbrain, M, Marwah, S, Mcbeth, P, Mihailescu, A, Morello, A, Mulita, F, Murzi, V, Mohammad, A, Parmar, S, Pak, A, Wong, M, Pantalone, D, Podda, M, Puccioni, C, Rasa, K, Ren, J, Roscio, F, Gonzalez-Sanchez, A, Sganga, G, Scheiterle, M, Slavchev, M, Smirnov, D, Tosi, L, Trivedi, A, Vega, J, Waledziak, M, Xenaki, S, Winter, D, Wu, X, Zakaria, A, Zakaria, Z, Kirkpatrick A. W., Coccolini F., Tolonen M., Minor S., Catena F., Gois E., Doig C. J., Hill M. D., Ansaloni L., Chiarugi M., Tartaglia D., Ioannidis O., Sugrue M., Colak E., Hameed S. M., Lampela H., Agnoletti V., McKee J. L., Garraway N., Sartelli M., Ball C. G., Parry N. G., Voght K., Julien L., Kroeker J., Roberts D. J., Faris P., Tiruta C., Moore E. E., Ammons L. A., Anestiadou E., Bendinelli C., Bouliaris K., Carroll R., Ceresoli M., Favi F., Gurrado A., Rezende-Neto J., Isik A., Cremonini C., Strambi S., Koukoulis G., Testini M., Trpcic S., Pasculli A., Picariello E., Abu-Zidan F., Adeyeye A., Augustin G., Alconchel F., Altinel Y., Hernandez Amin L. A., Aranda-Narvaez J. M., Baraket O., Biffl W. L., Baiocchi G. L., Bonavina L., Brisinda G., Cardinali L., Celotti A., Chaouch M., Chiarello M., Costa G., de'Angelis N., De Manzini N., Delibegovic S., Di Saverio S., De Simone B., Dubuisson V., Fransvea P., Garulli G., Giordano A., Gomes C., Hayati F., Huang J., Ibrahim A. F., Huei T. J., Jailani R. F., Khan M., Luna A. P., Malbrain M. L. N. G., Marwah S., McBeth P., Mihailescu A., Morello A., Mulita F., Murzi V., Mohammad A. T., Parmar S., Pak A., Wong M. P. -K., Pantalone D., Podda M., Puccioni C., Rasa K., Ren J., Roscio F., Gonzalez-Sanchez A., Sganga G., Scheiterle M., Slavchev M., Smirnov D., Tosi L., Trivedi A., Vega J. A. G., Waledziak M., Xenaki S., Winter D., Wu X., Zakaria A. D., Zakaria Z., Kirkpatrick, A, Coccolini, F, Tolonen, M, Minor, S, Catena, F, Gois, E, Doig, C, Hill, M, Ansaloni, L, Chiarugi, M, Tartaglia, D, Ioannidis, O, Sugrue, M, Colak, E, Hameed, S, Lampela, H, Agnoletti, V, Mckee, J, Garraway, N, Sartelli, M, Ball, C, Parry, N, Voght, K, Julien, L, Kroeker, J, Roberts, D, Faris, P, Tiruta, C, Moore, E, Ammons, L, Anestiadou, E, Bendinelli, C, Bouliaris, K, Carroll, R, Ceresoli, M, Favi, F, Gurrado, A, Rezende-Neto, J, Isik, A, Cremonini, C, Strambi, S, Koukoulis, G, Testini, M, Trpcic, S, Pasculli, A, Picariello, E, Abu-Zidan, F, Adeyeye, A, Augustin, G, Alconchel, F, Altinel, Y, Hernandez Amin, L, Aranda-Narvaez, J, Baraket, O, Biffl, W, Baiocchi, G, Bonavina, L, Brisinda, G, Cardinali, L, Celotti, A, Chaouch, M, Chiarello, M, Costa, G, De'Angelis, N, De Manzini, N, Delibegovic, S, Di Saverio, S, De Simone, B, Dubuisson, V, Fransvea, P, Garulli, G, Giordano, A, Gomes, C, Hayati, F, Huang, J, Ibrahim, A, Huei, T, Jailani, R, Khan, M, Luna, A, Malbrain, M, Marwah, S, Mcbeth, P, Mihailescu, A, Morello, A, Mulita, F, Murzi, V, Mohammad, A, Parmar, S, Pak, A, Wong, M, Pantalone, D, Podda, M, Puccioni, C, Rasa, K, Ren, J, Roscio, F, Gonzalez-Sanchez, A, Sganga, G, Scheiterle, M, Slavchev, M, Smirnov, D, Tosi, L, Trivedi, A, Vega, J, Waledziak, M, Xenaki, S, Winter, D, Wu, X, Zakaria, A, Zakaria, Z, Kirkpatrick A. W., Coccolini F., Tolonen M., Minor S., Catena F., Gois E., Doig C. J., Hill M. D., Ansaloni L., Chiarugi M., Tartaglia D., Ioannidis O., Sugrue M., Colak E., Hameed S. M., Lampela H., Agnoletti V., McKee J. L., Garraway N., Sartelli M., Ball C. G., Parry N. G., Voght K., Julien L., Kroeker J., Roberts D. J., Faris P., Tiruta C., Moore E. E., Ammons L. A., Anestiadou E., Bendinelli C., Bouliaris K., Carroll R., Ceresoli M., Favi F., Gurrado A., Rezende-Neto J., Isik A., Cremonini C., Strambi S., Koukoulis G., Testini M., Trpcic S., Pasculli A., Picariello E., Abu-Zidan F., Adeyeye A., Augustin G., Alconchel F., Altinel Y., Hernandez Amin L. A., Aranda-Narvaez J. M., Baraket O., Biffl W. L., Baiocchi G. L., Bonavina L., Brisinda G., Cardinali L., Celotti A., Chaouch M., Chiarello M., Costa G., de'Angelis N., De Manzini N., Delibegovic S., Di Saverio S., De Simone B., Dubuisson V., Fransvea P., Garulli G., Giordano A., Gomes C., Hayati F., Huang J., Ibrahim A. F., Huei T. J., Jailani R. F., Khan M., Luna A. P., Malbrain M. L. N. G., Marwah S., McBeth P., Mihailescu A., Morello A., Mulita F., Murzi V., Mohammad A. T., Parmar S., Pak A., Wong M. P. -K., Pantalone D., Podda M., Puccioni C., Rasa K., Ren J., Roscio F., Gonzalez-Sanchez A., Sganga G., Scheiterle M., Slavchev M., Smirnov D., Tosi L., Trivedi A., Vega J. A. G., Waledziak M., Xenaki S., Winter D., Wu X., Zakaria A. D., and Zakaria Z.

Abstract

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 co

Published
2023

2. Ethical considerations in conducting surgical research in severe complicated intra-abdominal sepsis

Author

Doig, C. J., Page, S. A., Mckee, J. L., Moore, E. E., Abu-Zidan, F. M., Carroll, R., Marshall, J. C., Faris, P. D., Tolonen, M., Catena, F., Cocolini, F., Sartelli, M., Ansaloni, L., Minor, S. F., Peirera, B. M., Diaz, J. J., Kirkpatrick, A. W., Roberts, D. J., Leppaniemi, A., Jenne, C. N., Odobez, Chiara, Kubes, P., Manns, B., Kluger, Y., Fraga, G. P., Pereira, B. M., Sugrue, M., Holm, T., Ren, J., Ball, C. G., Coimbra, R., Balogh, Z. J., Dixon, E., Biffl, W., Maclean, A., Ball, I., Drover, J. W., Mcbeth, P. B., Posadas-Calleja, J. G., Parry, N. G., Di Saverio, S., Ordonez, C. A., Bendinelli, C., Macdonald, B., Dunham, M., Reso, A., Vogt, K. N., Blaser, A. R., Malbrain, M., Tartaglia, D., De Waele, J., Dubuisson, V., Lampela, H., Bodnar, Z., Isik, A., Picetti, E., Hameed, M., Garraway, N. R., Julien, L., Widder, S., Bradley, N. L., Engels, P. T., Leeper, W. R., Beckett, A., Supporting clinical sciences, and Intensive Care

Subjects
medicine.medical_specialty, Open-abdomen, lcsh:Surgery, Intra-peritoneal sepsis, multiple organ dysfunction, Review, 030230 surgery, 03 medical and health sciences, 0302 clinical medicine, Sepsis, Humans, Medicine, Prospective Studies, Digestive System Surgical Procedures, Medicine(all), Surgical research, Informed Consent, business.industry, lcsh:Medical emergencies. Critical care. Intensive care. First aid, Correction, lcsh:RD1-811, lcsh:RC86-88.9, WAIVER, 3. Good health, Intra abdominal sepsis, Surgery, Research Design, Randomized Controlled Trial, Emergency Medicine, Consent, Multiple organ dysfunction, Randomized controlled trial, Waiver, consent, business
Abstract

Background Severe complicated intra-abdominal sepsis (SCIAS) has high mortality, thought due in part to progressive bio-mediator generation, systemic inflammation, and multiple organ failure. Treatment includes early antibiotics and operative source control. At surgery, open abdomen management with negative-peritoneal-pressure therapy (NPPT) has been hypothesized to mitigate MOF and death, although clinical equipoise for this operative approach exists. The Closed or Open after Laparotomy (COOL) study (https://clinicaltrials.gov/ct2/show/NCT03163095) will prospectively randomize eligible patients intra-operatively to formal abdominal closure or OA with NPTT. We review the ethical basis for conducting research in SCIAS. Main body Research in critically ill incapacitated patients is important to advance care. Conducting research among SCIAS is complicated due to the severity of illness including delirium, need for emergent interventions, diagnostic criteria confirmed only at laparotomy, and obtundation from anaesthesia. In other circumstances involving critically ill patients, clinical experts have worked closely with ethicists to apply principles that balance the rights of patients whilst simultaneously permitting inclusion in research. In Canada, the Tri-Council Policy Statement-2 (TCPS-2) describes six criteria that permit study enrollment and randomization in such situations: (a) serious threat to the prospective participant requires immediate intervention; (b) either no standard efficacious care exists or the research offers realistic possibility of direct benefit; (c) risks are not greater than that involved in standard care or are clearly justified by prospect for direct benefits; (d) prospective participant is unconscious or lacks capacity to understand the complexities of the research; (e) third-party authorization cannot be secured in sufficient time; and (f) no relevant prior directives are known to exist that preclude participation. TCPS-2 criteria are in principle not dissimilar to other (inter)national criteria. The COOL study will use waiver of consent to initiate enrollment and randomization, followed by surrogate or proxy consent, and finally delayed informed consent in subjects that survive and regain capacity. Conclusions A delayed consent mechanism is a practical and ethical solution to challenges in research in SCIAS. The ultimate goal of consent is to balance respect for patient participants and to permit participation in new trials with a reasonable opportunity for improved outcome and minimal risk of harm.

Published
2019
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7. Randomised controlled trial comparing marksmanship following application of a tourniquet or haemostatic clamp in healthy volunteers

Author

LaPorta, Anthony, Kirkpatrick, A W, Mckee, J L, Roberts, D J, Tien, H, Beckett, A, Ball, C G, Mckee, I, Louw, D, and Holcomb, J B

Abstract

BackgroundIn a care under fire situation, a first line response to haemorrhage is to apply a tourniquet and return fire. However, there is little understanding of how tourniquets and other haemorrhage control devices impact marksmanship.MethodsWe compared the impact of the iTClamp and the Combat Application Tourniquet (CAT) on marksmanship. Following randomisation (iTClamp or CAT), trained marksmen fired an AR15 at a scaled silhouette target in prone unsupported position (shooting task). Subjects then attempted to complete the shooting task at 5, 10, 15, 30 and 60 min post-haemorrhage control device application.ResultsAll of the clamp groups (n=7) completed the 60 min shooting task. Five CAT groups (n=6) completed the 5 min shooting task and one completed the 5 and 10 min shooting task before withdrawing. Four CAT groups were stopped due to unsafe handling; two stopped due to pain. When examining hits on mass (HOM) for the entire shooting task, there was no significant difference between tourniquet and iTClamp HOM at 5 min (p=0.18). However, there was a significant difference at 10 min, p=0.003 with tourniquet having significantly fewer HOM (1.7±2.7 HOM) than the iTClamp (8.1±3.3 HOM) group. The total effective HOM for the entire 60 min shooting task showed that the iTClamp group achieved significantly (p=0.001) more HOM than the tourniquet group. Over the entire 60 min shooting exercise, the iTClamp group achieved a median 72% (52/72) of available HOM while the tourniquet group obtained 19% (14/72).ConclusionsApplication of a tourniquet to the dominant arm negates effective return of fire in a care under fire setting after a brief time window. Haemorrhage control devices that preserve function may have a role in care under fire situations, as preserving effectiveness in returning fire has obvious operational merits.

Published
2017
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9. Ozone Uptake in Healthy Adult Males during Quiet Breathing1.

Author

WIESTER, M. J., STEVENS, M. A., MENACHE, M. G., MCKEE, J. L., and GERRITY, T. R.

Subjects
RESPIRATORY infections, PULMONARY gas exchange, DRUG dosage, RADIATION dosimetry, RESPIRATORY diseases
Abstract

Experimental measurements of ozone (O3) uptake are needed for validation of dosimetry model parameters and in predictions as well as for determining factors affecting uptake and for making comparisons between subpopulations or across species. In this study, 10 healthy adult male subjects were exposed to 0.3 ppm O3 while seated and breathing naturally through the nose or mouth. Total respiratory tract O3 uptake, spontaneous breathing parameters, and respiratory gas exchange were measured for 10 min under steady-state conditions. The exposure protocol was replicated in each subject approximately 2 weeks after the first visit. On each visit, health exams were performed and spirometric lung measurements were obtained. The experimental design provided comparisons of total O3 uptake during nasal and oral breathing, differences in uptake in an individual at two time points, and an examination of between-subject variability in O3 uptake. Exposure to O3 had no effect on the breathing parameters or gas exchange. Oral and nasal breathing frequency averaged 16.2±1.1 (SE) and 16.0±1.2 breaths per minute with tidal volumes averaging 651±46 and 669±67 ml, respectively. A significant correlation (p<0.01) was found for the minute volume during resting breathing with the percentage of uptake. The percentage of O3 uptake was consistently higher (p = 0.02) during oral breathing (76.5% ±3.3) than during nasal breathing (73.1% ±3.0) although this difference may not be biologically significant The variability in percentage of uptake between subjects was substantial with calculated uptakes ranging from 51 to 96%, a difference of about 45%. Variability in percentage of uptake for an individual was less with the maximal difference between the first and second visits being about 20%; the average difference, however, was only about 3%. We conclude that total percentage of O3 uptake is approximately 75% in adult males during resting breathing. It is slightly greater during oral than during nasal breathing, will vary considerably among subjects, and is moderately reproducible within a subject. [ABSTRACT FROM AUTHOR]

Published
1996
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13. A Card.

Author

McKEE, J. L.

Published
1874

14. Air medical transport: what the family wants to know.

Author

Fultz JH, McKee JL, Zalaznik FR, and Kidd PS

Subjects
Adult, Aged, Factor Analysis, Statistical, Female, Humans, Kentucky, Middle Aged, Stress, Psychological, Surveys and Questionnaires, Air Ambulances, Consumer Behavior statistics & numerical data, Information Services statistics & numerical data, Professional-Family Relations
Abstract

Introduction: The needs of family members of intensive care unit patients are well-documented, but there is little published about the specific needs of family members of air medical patients., Purpose: This study was devised to identify family member's information needs regarding air medical transport., Methods: Using a descriptive correlational design, 100 family members of air medical patients completed a 14-item Likert-format questionnaire. Each item addressed an information need and asked how important the information was to the family member and how much of this information they received., Results: The information needs most frequently ranked as very important related to the patient's condition, the patient's admitting unit at the receiving hospital, and being able to see the patient prior to flight. Information most frequently received by the family related to the patient's condition., Conclusion: Flight crews need to be cognizant of families' needs and develop ways to improve communication with the family to meet those needs.

Published
1993
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15. Fractal and morphometric analysis of lung structures after canine adenovirus-induced bronchiolitis in beagle puppies.

Author

Witten ML, McKee JL, Lantz RC, Hays AM, Quan SF, Sobonya RE, and Lemen RJ

Subjects
Adenoviridae Infections physiopathology, Animals, Animals, Newborn, Anthropometry, Bronchiolitis microbiology, Bronchiolitis physiopathology, Dogs, Lung growth & development, Models, Biological, Adenoviridae Infections pathology, Bronchiolitis pathology, Lung pathology
Abstract

Acute viral respiratory infections are commonly associated with alteration in lung growth and with chronic obstructive disease. However, it is difficult to quantify these changes in lung function. We determined that the recently described techniques of fractal analysis gave additional information about the changes in lung function after viral illness compared to standard morphometric techniques. Fractal and morphometric parameters change with lung growth after acute infection with canine adenovirus type 2 (CAV2, n = 5) or no infection (controls, n = 6) in beagle puppies. Lung pathological studies showed areas of obliterative bronchiolitis and chronic small airways inflammation but no emphysema in the CAV2-infected puppies. Morphometric studies at approximately 236 days of age demonstrated accelerated lung growth in the CAV2-infected dogs as evidenced by significant increases in lung volume (VL) and internal surface area (ISA). Fractal analysis showed an increased fractal dimension (Df) of the alveolar perimeter length in the CAV2 group associated with increased growth that was similar to the percentage change in VL and ISA. These data suggest that a single infection with CAV2 in beagle puppies accelerates lung growth and increases the complexity (Df) of the alveolar structure.

Published
1993
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