Optimal Tissue Perfusion Clinical Trial
Official title:
Effects of Intraoperative, Goal-directed Crystalloid vs. Colloid Fluid Resuscitation on Microcirculation in Free Flap Reconstruction of Intraoral Tumours.
Verified date | May 2019 |
Source | Szeged University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Maintaining satisfactory tissue perfusion is an essential of success during reconstructive free flap surgery following malign oral cavity tumours. Intra- and postoperative goal-directed fluid therapy is an appropriate tool for that. Continuous cardiac output monitoring based fluid loading (complemented with vasopressor and/or inotropes if necessary) might be superior to conventional, central venous and arterial pressure monitoring in terms of morbidity, complications, optimal fluid balance and days spent in hospital. However, there is no data describing the effects of goal-directed fluid therapy (crystalloid or colloid) on microcirculation of free flaps implanted in the oral cavity during the post-operative period. The aim of this study is to observe the effects of continuous macrohaemodynamic monitoring based, goal-directed fluid therapy on microcirculation of forearm flaps during the perioperative period.
Status | Completed |
Enrollment | 30 |
Est. completion date | September 19, 2018 |
Est. primary completion date | February 28, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Age over 18 - Tumour location: intraoral - Free flap type: radial forearm - Signed informed concent form Exclusion Criteria: - Vulnerable subject as defined in International Standards Organization 14155:2011 - End stage oral cancer |
Country | Name | City | State |
---|---|---|---|
Hungary | Department of Anaesthesiology and Intensive Therapy | Szeged | Csongrád |
Lead Sponsor | Collaborator |
---|---|
Szeged University | Department of Oral and Maxillofacial Surgery, University of Szeged, Institute of Surgical Research, University of Szeged |
Hungary,
Cecconi M, Hofer C, Teboul JL, Pettila V, Wilkman E, Molnar Z, Della Rocca G, Aldecoa C, Artigas A, Jog S, Sander M, Spies C, Lefrant JY, De Backer D; FENICE Investigators; ESICM Trial Group. Fluid challenges in intensive care: the FENICE study: A global inception cohort study. Intensive Care Med. 2015 Sep;41(9):1529-37. doi: 10.1007/s00134-015-3850-x. Epub 2015 Jul 11. Erratum in: Intensive Care Med. 2015 Sep;41(9):1737-8. multiple investigator names added. — View Citation
Hölzle F, Rau A, Loeffelbein DJ, Mücke T, Kesting MR, Wolff KD. Results of monitoring fasciocutaneous, myocutaneous, osteocutaneous and perforator flaps: 4-year experience with 166 cases. Int J Oral Maxillofac Surg. 2010 Jan;39(1):21-8. doi: 10.1016/j.ijom.2009.10.012. Epub 2009 Nov 26. — View Citation
Salzwedel C, Puig J, Carstens A, Bein B, Molnar Z, Kiss K, Hussain A, Belda J, Kirov MY, Sakka SG, Reuter DA. Perioperative goal-directed hemodynamic therapy based on radial arterial pulse pressure variation and continuous cardiac index trending reduces postoperative complications after major abdominal surgery: a multi-center, prospective, randomized study. Crit Care. 2013 Sep 8;17(5):R191. doi: 10.1186/cc12885. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes of Pulse pressure variation during the operation and the post-operative 24 hours | 24 hours | ||
Primary | Assesment of free falp microcirculation by laser dopler flowmetry method. | 24 hours | ||
Primary | Total need of Norepinephrine and Dobutamine during surgery and the post-operative 24 hours. | 24 hours | ||
Primary | Changes of Cardiac Index during the operation and the post-operative 24 hours. | 24 hours | ||
Primary | Mean arterial pressure during the operation and the post-operative 24 hours. | 24 hours | ||
Secondary | Length of Intensive Care Unit stay | 24 hours | ||
Secondary | Number of surgical or non-surgical complications. | 24 hours | ||
Secondary | Length of Hospital stay | 10 days |