Advanced Hemodynamic Monitoring in Free Flap Surgery

NCT ID: NCT03168126

Last Updated: 2017-05-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 31 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2014-12-31

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.

Detailed Description

We conducted a prospective cohort study in accordance with the WMA Declaration of Helsinki. Standard general anesthesia with intubation and administration of sufentanil, propofol and esmeron relaxant was performed in all patients undergoing primary free flap reconstruction in course of a head and neck tumor reconstruction. Hemodynamic monitoring measurement of cardiac index and the parameter stroke volume variation as surrogate for cardiac pre-load was performed using a Pro-AQT Monitor. Using an arterial catheter previously set by the Seldinger technique as part of the standard equipment, the mean, diastolic and systolic arterial pressure was measured as part of the standard monitoring as presented. This tube was previously deaerated and flushed with 2% NaCl and connected in series with a sensor, which passes over electric line signals to the Pro-AQT-Monitor®. Based on previously entered patient data and an analysis of the arterial pulse curve characteristics, a cardiac index (CI) start-value is determined by the system. The sampling of the arterial pressure characteristics is affected by a signal having a frequency of 250 Hz. The start value is the basis for the further determination of HI trend values. The arterial pulse contour is continuously tapped and analyzed and offset against the determined start value. To calculate the cardiac index, the PICCO®-pulse contour algorithm is applied. Every 12 seconds, a new measurement is performed and documented by the system.

From the read logs ProAQT Monitor® the values of the CI, MAP, HR, stroke volume index (SVI), the stroke volume variation (SVV) and the systemic resistance index (SRI) were recorded at different measurement intervals throughout the operation. All parameters were evaluated for volume control in the course of the study.

Conditions

Hemodynamic Rebound; Volume Overload; Fluid Overload; Bloodpressure

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Pro-AQT-Monitoting

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

Pro-AQT

Intervention Type: DEVICE

Use of the device for advanced hemodynamic monitoring

Interventions

Pro-AQT

Use of the device for advanced hemodynamic monitoring

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• <18 years of age, no informed consent

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Johannes Wikner, MD DMD

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum Hamburg-Eppendorf

References

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.

Reference Type: BACKGROUND

PMID: 16155038 (View on PubMed)

Other Identifiers

002

Identifier Type: -

Identifier Source: org_study_id