Advanced Hemodynamic Monitoring in Free Flap Surgery

NCT03168126 | Completed

• 1 other identifier: 002
• Study Type: observational
• Target: 31
• Locations: 0 countries
• Sites: N/A

Brief Summary

Background: Anesthesia in free flap surgery is challenging. Monitoring of hemodynamic changes and their influence on the cardiovascular system in permanent feedback loops allow control, which is what anesthesiologists aim for to ensure an adequate blood flow and tissue oxygenation. The circulatory support and inferable volume administration are managed via heart rate (HR) and mean arterial pressure (MAP), but both parameters are influenced by variable components and are thus unfavorable for volume management. The aim of this study was to evaluate whether volume requirement may be assumable to additional monitoring parameters. Methods: 31 patients were enrolled prospectively. HR, MAP, central venous pressure and O2 saturation were comprehended based on the protocols. We expanded the data set by a permanent blinded intraoperative monitoring with registration of the Cardiac Index (CI) and Stroke Volume Variation (SVV) and semi-invasive pulse-contour analysis utilizing the Pro-AQT-Device.

Conditions

Hemodynamic Rebound; Volume Overload; Fluid Overload; Bloodpressure

Outcome Measures

Primary Outcomes (1)

• Stroke Volume Variance (SVV)

  during the surgical intervention

Secondary Outcomes (4)

• Mean arterial pressure

  during the surgical intervention

• heart rate

  during the surgical intervention

• cardiac index

  during the surgical intervention

• standard resistance index

  during the surgical intervention

Study Arms (1)

Pro-AQT-Monitoting

Patients with OSCC of the jaws and tumor resection + primary free flap reconstruction

Device: Pro-AQT

Interventions

Pro-AQT DEVICE

Use of the device for advanced hemodynamic monitoring

Pro-AQT-Monitoting

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients with oral squamous cell carcinoma undergoing tumor resection + primary reconstruction with a free flap

You may qualify if:

• years of age, free flap surgery, oral squamous cell carcinoma, informed consent

You may not qualify if:

• \<18 years of age, no informed consent

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Related Publications (1)

• Wakeling HG, McFall MR, Jenkins CS, Woods WG, Miles WF, Barclay GR, Fleming SC. Intraoperative oesophageal Doppler guided fluid management shortens postoperative hospital stay after major bowel surgery. Br J Anaesth. 2005 Nov;95(5):634-42. doi: 10.1093/bja/aei223. Epub 2005 Sep 9.

  PMID: 16155038 BACKGROUND

MeSH Terms

Conditions

Edema

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Johannes Wikner, MD DMD

  Universitätsklinikum Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2017
• First Posted: May 30, 2017
• Study Start: January 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: May 30, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share