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Cardiac Output Monitoring in Aortic Aneurysm Surgery

Primary Purpose

Aneurysm

Status

Completed

Phase

Locations

United Kingdom

Study Type

Observational

Intervention

About this trial

This is an observational trial for Aneurysm focused on measuring Aortic aneurysm repair

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients presenting for elective abdominal aortic and extent 4 thoracoabdominal aortic aneurysm repair

Exclusion Criteria:

Patients not giving informed consent.
Patients under the age of 18 years.
Patients who may be pregnant
Patients with learning disabilities.
Rhythm other than sinus rhythm.
Patients on oral lithium therapy.
Patients less than 40kg
Patients with severe mitral regurgitation

Sites / Locations

NHS Lothian

Arms of the Study

Arm 1

Arm Type

Arm Label

Repair

Arm Description

Outcomes

Primary Outcome Measures

Cardiac output

Secondary Outcome Measures

Arterial Pressure

Full Information

NCT ID

NCT01094938

First Posted

March 26, 2010

Last Updated

March 26, 2010

Sponsor

NHS Lothian

1. Study Identification

Unique Protocol Identification Number

NCT01094938

Brief Title

Cardiac Output Monitoring in Aortic Aneurysm Surgery

Study Type

Observational

2. Study Status

Record Verification Date

March 2010

Overall Recruitment Status

Completed

Study Start Date

July 2007 (undefined)

Primary Completion Date

July 2007 (Actual)

Study Completion Date

July 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

NHS Lothian

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

To compare CO values obtained by the lithium indicator dilution method and pulse power analysis before, during and after anaesthesia and surgery for the elective repair of abdominal aortic aneurysms. This will enable us to determine how often and when calibration of the pulse power analysis derived CO is required.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Aneurysm

Keywords

Aortic aneurysm repair

7. Study Design

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Repair

Primary Outcome Measure Information:

Title

Cardiac output

Secondary Outcome Measure Information:

Title

Arterial Pressure

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients presenting for elective abdominal aortic and extent 4 thoracoabdominal aortic aneurysm repair Exclusion Criteria: Patients not giving informed consent. Patients under the age of 18 years. Patients who may be pregnant Patients with learning disabilities. Rhythm other than sinus rhythm. Patients on oral lithium therapy. Patients less than 40kg Patients with severe mitral regurgitation

Study Population Description

Edinburgh based trial in aortic aneurysm repair

Sampling Method

Non-Probability Sample

Facility Information:

Facility Name

NHS Lothian

City

Edinburgh

ZIP/Postal Code

EH16 4SA

Country

United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Cardiac Output Monitoring in Aortic Aneurysm Surgery

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