Haemodynamic Monitoring in Head and Neck Cancer Patients

NCT ID: NCT02715310

Last Updated: 2016-03-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-03-31

Study Completion Date

2018-02-28

Brief Summary

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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

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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.

Conditions

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Postoperative Complications

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Technical University of Munich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Denys Loeffelbein, PhD, MD, DDS

Role: STUDY_CHAIR

Technical University Muncih

Locations

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Department of Oral and Maxillofacial Surgery, Technische Universität München

Munich, Bavaria, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Thomas Mücke, PhD, MD, DDS

Role: CONTACT

00494140 ext. 5866

Florian Guell, MD

Role: CONTACT

00494140 ext. 4994

Facility Contacts

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Thomas Mücke, PhD, MD, DDS

Role: primary

00494140 ext. 5866

Florian Guell, MD

Role: backup

00494140 ext. 4994

Other Identifiers

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MKG HN 1

Identifier Type: -

Identifier Source: org_study_id

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