Condition category
Circulatory System
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
16/08/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr A Norman

ORCID ID

Contact details

Department of Anaesthesia
D Floor
Jubilee Building
Leeds General Infirmary
Leeds
LS1 3EX
United Kingdom
+44 (0)113 243 2799

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0436117979

Study information

Scientific title

Acronym

Study hypothesis

To measure the accuracy of the VasotracĀ® monitor compared with an arterial line in the morbidly obese patient. If there is agreement we may be able to use it instead.

Ethics approval

Not provided at time of registration

Study design

Randomised active controlled parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Condition

Hypertension

Intervention

Randomised controlled trial. Random allocation to:
1. Blood pressure monitor
2. Arterial cannula

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

The correlation of readings between the readings from the Vasotrac and an arterial line.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/07/2002

Overall trial end date

01/07/2003

Reason abandoned

Eligibility

Participant inclusion criteria

Any patient presenting for surgery with a body mass index (BMI) >35 and requiring arterial cannula.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/07/2002

Recruitment end date

01/07/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Anaesthesia
Leeds
LS1 3EX
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Hospital/treatment centre

Funder name

Leeds Teaching Hospitals NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes