Cardiac Output Monitoring in Aortic Aneurysm Surgery | NCT01094938

Studies
Cardiac Output Monitoring in Aortic Aneurysm Surgery

NCT01094938

Sponsor

NHS Lothian

Status

Completed

Last Update Posted

Sep 23, 2024Actual

Enrollment

30Actual

Phase

Not provided

Conditions

Aneurysm

Interventions

Not provided

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
07/S1102/30	Other Identifier	NHS Lothian

Status Module

Record Verification Date

Mar 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2007

Primary Completion Date

Jul 2007Actual

Completion Date

Jul 2008Actual

First Submitted Date

Mar 26, 2010

First Submission Date that Met QC Criteria

Mar 26, 2010

First Posted Date

Mar 29, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 20, 2024

Last Update Posted Date

Sep 23, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Label	Type	Description	Intervention Names
Repair

Measure	Description	Time Frame
Cardiac output

Measure	Description	Time Frame
Arterial Pressure

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Edinburgh based trial in aortic aneurysm repair

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
NHS Lothian		Edinburgh		EH16 4SA	United Kingdom

Condition Browse Module

MeSH Terms

ID	Term
D000783	Aneurysm

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided