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The Nexfin monitoring system offers a complete non-invasive approach to a continuously estimation of blood pressure, CI and PPV by means of finger-cuff based pulse contour analysis. Several clinical investigations have proven reliability and interchangeability of the Nexfin technology yielding acceptable results especially regarding the trending abilities. At present there is no evidence available, whether a early goal directed hemodynamic optimization protocol based on a completely non-invasive monitoring technology is able to reduce postoperative complication. Therefore, the aim of this single-center study is to compare the clinical outcome and postoperative complications of patients undergoing major colorectal surgery treated with standard of care or with a GDT protocol based on the Nexfin technology.
The Nexfinâ„¢ monitoring system is able to provide continuous beat-to-beat stroke volume index (SVI), stroke volume variation (SVV), pulse pressure variation (PPV), cardiac index (CI) and arterial pressure by using an inflatable finger cuff. This system consists of a frequency dependent transfer function for calculation of brachial artery pressure from the finger artery pressure.
Major surgery bares the risk of concealed hypoperfusion and therefore possible mismatch in oxygen delivery and oxygen demand. It must be noted, that the "basic" perioperative monitoring, i.e. electrocardiogram, oxygen saturation and non-invasive or invasive blood pressure measurements is not able to accurately detect hypovolemia and ongoing organ hypoperfusion. Perioperatively, patients undergoing major abdominal surgery are prone to high risk of hemodynamic instabilities and consequently relevant changes in oxygen delivery, associated with an increase in postoperative complications and length of stay in hospital. Over the last years several studies focused on early goal directed hemodynamic therapy (GDT) with strong proof for the feasibility of such algorithms and the improvement in patient's outcome with respect to certain clinical scenarios.However, there is still a debate regarding an individualized GDT approach, based on pre-procedural defined individualized hemodynamic goals yielded by an advanced haemodynamic monitoring technology. We do have to distinguish which monitoring system, invasive to non-invasive, matches the kind of estimated risk at what time best.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group (SG) | Other | Before induction of anaesthesia:
Study Group:
|
|
| Control group (CG) | No Intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dobutamine | Drug | If PPV ≤10%, volume substitution of 500 ml of crystalloids and/or colloids as long as CI was ≥2.5 l/min/m². Maintenance of CI ≥2.5 l/min/m² and MAP ≥65 mmHg was achieved by using dobutamine (10 µg/kg/min) and norepinephrine (0.03 µg/kg/min). |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative complications | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Length of hospital stay (LOS) | 28 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ole Broch | Kiel | Schleswig-Holstein | 24105 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21873370 | Background | Challand C, Struthers R, Sneyd JR, Erasmus PD, Mellor N, Hosie KB, Minto G. Randomized controlled trial of intraoperative goal-directed fluid therapy in aerobically fit and unfit patients having major colorectal surgery. Br J Anaesth. 2012 Jan;108(1):53-62. doi: 10.1093/bja/aer273. Epub 2011 Aug 26. | |
| 22499750 | Background |
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| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Not provided
| ID | Term |
|---|---|
| D004280 | Dobutamine |
| D009638 | Norepinephrine |
| D000077324 | Crystalloid Solutions |
| D003102 | Colloids |
| ID | Term |
|---|---|
| D002395 | Catecholamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D010627 | Phenethylamines |
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|
| Toyama S, Shimoyama M. Goal-directed fluid therapy in patients undergoing colorectal surgery. Br J Anaesth. 2012 May;108(5):877-8; author reply 878-9. doi: 10.1093/bja/aes110. No abstract available. |
| 24048581 | Background | Zheng H, Guo H, Ye JR, Chen L, Ma HP. Goal-directed fluid therapy in gastrointestinal surgery in older coronary heart disease patients: randomized trial. World J Surg. 2013 Dec;37(12):2820-9. doi: 10.1007/s00268-013-2203-6. |
| 24056586 | Background | Yates DR, Davies SJ, Milner HE, Wilson RJ. Crystalloid or colloid for goal-directed fluid therapy in colorectal surgery. Br J Anaesth. 2014 Feb;112(2):281-9. doi: 10.1093/bja/aet307. Epub 2013 Sep 20. |
| 24841970 | Background | Bennett-Guerrero E. Hemodynamic goal-directed therapy in high-risk surgical patients. JAMA. 2014 Jun 4;311(21):2177-8. doi: 10.1001/jama.2014.5306. No abstract available. |
| 25463768 | Background | Srinivasa S, Taylor MH, Singh PP, Lemanu DP, MacCormick AD, Hill AG. Goal-directed fluid therapy in major elective rectal surgery. Int J Surg. 2014 Dec;12(12):1467-72. doi: 10.1016/j.ijsu.2014.11.010. Epub 2014 Nov 15. |
| 25759947 | Background | Gomez-Izquierdo JC, Feldman LS, Carli F, Baldini G. Meta-analysis of the effect of goal-directed therapy on bowel function after abdominal surgery. Br J Surg. 2015 May;102(6):577-89. doi: 10.1002/bjs.9747. Epub 2015 Mar 11. |
| 26088649 | Background | Cannesson M, Ramsingh D, Rinehart J, Demirjian A, Vu T, Vakharia S, Imagawa D, Yu Z, Greenfield S, Kain Z. Perioperative goal-directed therapy and postoperative outcomes in patients undergoing high-risk abdominal surgery: a historical-prospective, comparative effectiveness study. Crit Care. 2015 Jun 19;19(1):261. doi: 10.1186/s13054-015-0945-2. |
| 26089448 | Background | Hunsicker O, Scott MJ, Miller TE, Baldini G, Feldheiser A. Gastrointestinal morbidity as primary outcome measure in studies comparing crystalloid and colloid within a goal-directed therapy. Br J Anaesth. 2015 Jul;115(1):128-9. doi: 10.1093/bja/aev181. No abstract available. |
| 26116223 | Background | Gottlieb M, Bailitz J. Comparison of Early Goal-Directed Therapy With Usual Care for Severe Sepsis and Septic Shock. Ann Emerg Med. 2015 Dec;66(6):632-4. doi: 10.1016/j.annemergmed.2015.05.025. Epub 2015 Jun 24. No abstract available. |
| 26206652 | Background | Correa-Gallego C, Tan KS, Arslan-Carlon V, Gonen M, Denis SC, Langdon-Embry L, Grant F, Kingham TP, DeMatteo RP, Allen PJ, D'Angelica MI, Jarnagin WR, Fischer M. Goal-Directed Fluid Therapy Using Stroke Volume Variation for Resuscitation after Low Central Venous Pressure-Assisted Liver Resection: A Randomized Clinical Trial. J Am Coll Surg. 2015 Aug;221(2):591-601. doi: 10.1016/j.jamcollsurg.2015.03.050. Epub 2015 Apr 7. |
| D005021 |
| Ethylamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |