Haemodynamic Monitoring in Head and Neck Cancer Patients (HMHN)
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|ClinicalTrials.gov Identifier: NCT02715310|
Recruitment Status : Unknown
Verified March 2016 by Technische Universität München.
Recruitment status was: Recruiting
First Posted : March 22, 2016
Last Update Posted : March 23, 2016
|Condition or disease|
The extend of mass transfusions is known to correlate with postoperative complications. However, also crystalloid and colloidal infusions are under suspicion to cause postoperative complications. This study will capture any kind of fluid intervention perioperatively as well as intraoperatively. Intraoperative fluid management will be documented and matched with the operation steps respectively. The extend of fluid therapy will be correlated with general postoperative complications and especially with the survival of microvascular transplants.
For this purpose, there will be four questionaires. After informed consent, the first questionaire will cover the patient's history, risk factors and previous operations. The second questionaire will cover intraoperative fluid management, documented with the actual operation step. Furthermore, it will also intraoperative complications, cardiovascular-active medication. For closer monitoring, data from Picco will also be included. The third questionaire will be complete in the ICU covering similar content as the second questionaire. The last questionaire will cover the patient's progress on the general ward. Fluid management and tube feeding, as well as general postoperative complication and flap specific complications will be noted.
This study aims for 50-80 patients.
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|Study Start Date :||March 2016|
|Estimated Primary Completion Date :||February 2018|
|Estimated Study Completion Date :||February 2018|
- Postoperative Complications [ Time Frame: 1 week ]General Complications e.g. affecting lung, cardiovascular system, kidneys
- Transplant Survival via Clinical Examination [ Time Frame: One week ]Transplant Survival via Clinical Examination/ Need for further microvascular Transplant
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02715310
|Contact: Thomas Mücke, PhD, MD, DDS||00494140 ext firstname.lastname@example.org|
|Contact: Florian Guell, MD||00494140 ext email@example.com|
|Department of Oral and Maxillofacial Surgery, Technische Universität München||Recruiting|
|Munich, Bavaria, Germany, 81675|
|Contact: Thomas Mücke, PhD, MD, DDS 00494140 ext 5866 firstname.lastname@example.org|
|Contact: Florian Guell, MD 00494140 ext 4994 email@example.com|
|Study Chair:||Denys Loeffelbein, PhD, MD, DDS||Technical University Muncih|