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Patients who underwent an abdominal surgery and had the abdomen remain open are called to have an "open abdomen". To limit the risk of further widening of their wounds, surgeons can use AbClo, which is a non-invasive abdominal binding device, to keep the abdominal wall together (i.e., approximate the fascia). However, as the device also compresses on the abdomen and adjacent lungs, this study aims:
Participants will already be on the abdominal binding device when joining the study. Measurements on various aspects of the lung function (including its physical properties and capability to oxygenate the blood) will be done before and after adjustment of the abdominal binding device to the pressure (measured in the device itself) recommended by the manufacturer, as well as after the surgery to close the abdomen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abdominal fascial approximation device | All patients are already on the device before starting the study |
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| Measure | Description | Time Frame |
|---|---|---|
| Changes in End-expiratory Transpulmonary Pressure | Calculated by the difference between airway pressure and the value measured by an esophageal catheter at the end of expiration. Measurements are made once before the adjustment of the fascial approximation device to the optimal pressure, after the adjustment, and again after the surgery to close the abdomen. | On the day of enrolment and on the day of surgery to close the abdomen |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Lung Volume | Measured by a ventilator capable of measuring end-expiratory lung volume, using a breath-in-breath-out method. Measurements are made once before the adjustment of the fascial approximation device to the optimal pressure, and again after the adjustment. | On the day of enrolment |
| Changes in oxygenation function |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients admitted the ICU with open abdomen treated with AbClo device, and undergoing mechanical ventilation
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nattapat Wongtirawit, M.D. | Contact | 416-864-6060 | 6214 | nattapat.wongtirawit@unityhealth.to |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Michael's Hospital | Recruiting | Toronto | Ontario | M5B1W8 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17469720 | Background | Wauters J, Wilmer A, Valenza F. Abdomino-thoracic transmission during ACS: facts and figures. Acta Clin Belg. 2007;62 Suppl 1:200-5. | |
| 31025221 | Background | Regli A, Pelosi P, Malbrain MLNG. Ventilation in patients with intra-abdominal hypertension: what every critical care physician needs to know. Ann Intensive Care. 2019 Apr 25;9(1):52. doi: 10.1186/s13613-019-0522-y. |
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The datasets generated and/or analyzed during the current study will not be publicly available due participant confidentiality, according to the REB, but will be available from the corresponding author on reasonable request.
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Determined by the partial pressure of oxygen and PaO₂/FiO₂ ratio from arterial blood gas. Measurements are made once before the adjustment of the fascial approximation device to the optimal pressure, after the adjustment, and again after the surgery to close the abdomen. |
| On the day of enrolment and on the day of surgery to close the abdomen |
| Response in End-expiratory Transpulmonary Pressure to PEEP Increase | In participants with negative end-expiratory transpulmonary pressure with clinically set PEEP, under the supervision of the clinical team in the ICU, PEEP will be titrated up until until zero or positive values are restored. Responses to the titration will be recorded. | On the day of enrolment |
| 30776290 | Background | Beitler JR, Sarge T, Banner-Goodspeed VM, Gong MN, Cook D, Novack V, Loring SH, Talmor D; EPVent-2 Study Group. Effect of Titrating Positive End-Expiratory Pressure (PEEP) With an Esophageal Pressure-Guided Strategy vs an Empirical High PEEP-Fio2 Strategy on Death and Days Free From Mechanical Ventilation Among Patients With Acute Respiratory Distress Syndrome: A Randomized Clinical Trial. JAMA. 2019 Mar 5;321(9):846-857. doi: 10.1001/jama.2019.0555. |
| 29323931 | Background | Yoshida T, Amato MBP, Grieco DL, Chen L, Lima CAS, Roldan R, Morais CCA, Gomes S, Costa ELV, Cardoso PFG, Charbonney E, Richard JM, Brochard L, Kavanagh BP. Esophageal Manometry and Regional Transpulmonary Pressure in Lung Injury. Am J Respir Crit Care Med. 2018 Apr 15;197(8):1018-1026. doi: 10.1164/rccm.201709-1806OC. |
| 39411009 | Background | Naveed A, Martin ND, Bawazeer M, Jastaniah A, Rezende-Neto JB. Early placement of a non-invasive, pressure-regulated, fascial reapproximation device improves reduction of the fascial gap in open abdomens: a retrospective cohort study. Trauma Surg Acute Care Open. 2024 Oct 12;9(1):e001529. doi: 10.1136/tsaco-2024-001529. eCollection 2024. |
| 33225070 | Background | Rezende-Neto JB, Camilotti BG. New non-invasive device to promote primary closure of the fascia and prevent loss of domain in the open abdomen: a pilot study. Trauma Surg Acute Care Open. 2020 Nov 11;5(1):e000523. doi: 10.1136/tsaco-2020-000523. eCollection 2020. |
| 20539186 | Background | Diaz JJ Jr, Cullinane DC, Dutton WD, Jerome R, Bagdonas R, Bilaniuk JW, Collier BR, Como JJ, Cumming J, Griffen M, Gunter OL, Kirby J, Lottenburg L, Mowery N, Riordan WP Jr, Martin N, Platz J, Stassen N, Winston ES. The management of the open abdomen in trauma and emergency general surgery: part 1-damage control. J Trauma. 2010 Jun;68(6):1425-38. doi: 10.1097/TA.0b013e3181da0da5. |
| 37882630 | Background | Roberts DJ, Leppaniemi A, Tolonen M, Mentula P, Bjorck M, Kirkpatrick AW, Sugrue M, Pereira BM, Petersson U, Coccolini F, Latifi R. The open abdomen in trauma, acute care, and vascular and endovascular surgery: comprehensive, expert, narrative review. BJS Open. 2023 Sep 5;7(5):zrad084. doi: 10.1093/bjsopen/zrad084. |
| 23823991 | Background | Kreis BE, de Mol van Otterloo AJ, Kreis RW. Open abdomen management: a review of its history and a proposed management algorithm. Med Sci Monit. 2013 Jul 3;19:524-33. doi: 10.12659/MSM.883966. |
| 23673399 | Background | Kirkpatrick AW, Roberts DJ, De Waele J, Jaeschke R, Malbrain ML, De Keulenaer B, Duchesne J, Bjorck M, Leppaniemi A, Ejike JC, Sugrue M, Cheatham M, Ivatury R, Ball CG, Reintam Blaser A, Regli A, Balogh ZJ, D'Amours S, Debergh D, Kaplan M, Kimball E, Olvera C; Pediatric Guidelines Sub-Committee for the World Society of the Abdominal Compartment Syndrome. Intra-abdominal hypertension and the abdominal compartment syndrome: updated consensus definitions and clinical practice guidelines from the World Society of the Abdominal Compartment Syndrome. Intensive Care Med. 2013 Jul;39(7):1190-206. doi: 10.1007/s00134-013-2906-z. Epub 2013 May 15. |
| 35546420 | Background | Mahoney EJ, Bugaev N, Appelbaum R, Goldenberg-Sandau A, Baltazar GA, Posluszny J, Dultz L, Kartiko S, Kasotakis G, Como J, Klein E. Management of the open abdomen: A systematic review with meta-analysis and practice management guideline from the Eastern Association for the Surgery of Trauma. J Trauma Acute Care Surg. 2022 Sep 1;93(3):e110-e118. doi: 10.1097/TA.0000000000003683. Epub 2022 May 12. |