Haemodynamic Monitoring in Head and Neck Cancer Patients

• Conditions: Postoperative Complications

• Registration Number: NCT02715310
• Lead Sponsor: Technical University of Munich

Brief Summary

In order to estimate the effect of fluid management in regard to postoperative complications this observatory study will document every kind of fluid intervention peri- and intraoperatively.

Detailed Description

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 Timeline

• Status Verified: 2016-03
• Study Start: 2016-03
• Study First Submitted: 2016-03-07
• Study First Submitted QC: 2016-03-16
• Study First Posted: 2016-03-22
• Last Update Submitted: 2016-03-22
• Last Update Posted: 2016-03-23
• Primary Completion: 2018-02
• Study Completion: 2018-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• 18 years old or older
• admitted for head and neck surgery with microvascular transplantation due to head and neck tumors

Exclusion Criteria

• Pregnancy
• underage
• missing informed consent
• revisions and relapse operations
• non tumor-associated operations
• surgery without microvascular transplants

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Postoperative Complications	1 week	General Complications e.g. affecting lung, cardiovascular system, kidneys

Secondary Outcome Measures

Name	Time	Method
Transplant Survival via Clinical Examination	One week	Transplant Survival via Clinical Examination/ Need for further microvascular Transplant

Trial Locations

Locations (1)

Department of Oral and Maxillofacial Surgery, Technische Universität München; 🇩🇪 Munich, Bavaria, Germany