Study of the Natural Variation in Strokevolume

Stroke Volume Variation Clinical Trial

Official title:

Study of the Natural Variation in Strokevolume, and Investigation in the Number of Cycles Necessary to Find a 10% Strokevolume Variation Using Esophageal Doppler

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00447200
• Other study ID #: Validation of cycles
• Status: Completed
• Phase: N/A
• First received: March 13, 2007
• Last updated: October 12, 2007
• Start date: March 2007
• Est. completion date: August 2007

Study information

• Verified date: October 2007
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: National Board of Health
• Study type: Observational

Clinical Trial Summary

We would like to investigate the natural variation in the strokevolume of the heart. At the same time we would like to find out the minimal number of heart cycles necessary to discover a 10% increase in strokevolume, after a fluid bolus of 200ml Voluven, when using Esophageal Doppler.

Description:

We would like to investigate the natural variation in the strokevolume(SV) of the heart. At the same time we would like to find out the minimal number of heart cycles necessary to discover a 10% increase in SV, after a fluid bolus of 200ml Voluven, when using Esophageal Doppler.

Also we will compare the variation in SV both before and after the patients have been fluid optimized, using an algorithm of 10% increase in SV in order to receive another fluid bolus. The equipment used, will be the CardioQ from Deltex medical.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Planned abdominal surgery

Exclusion Criteria:

• Oesophageal pathology,

• Age >90 yr or <18 yr,

• Alcohol abuse,

• Aneurism in thoracic aorta

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Stroke Volume Variation

Intervention

Procedure:
• Esophagus Doppler monitoring

• Fluid optimization

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen	Seeland

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Strokevolume variation before fluid optimization
Primary	Strokevolume variation after fluid optimization
Primary	Number of cycles needed in order to detect a 10% strokevolume increase after fluid bolus of 200ml Voluven.