Assessment of the effects of pressors on graft blood flow after free tissue transfer surgery - Free 4 Flow

Conditions: Patients in need of free flap facial reconstructive surgery

Registration Number: EUCTR2008-000073-37-GB

Lead Sponsor: Oxford Radcliffe Hospitals NHS Trust

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Patients eligible for inclusion are those undergoing oral reconstruction using free flaps at the John Radcliffe Hospital in Oxford and expected to be admitted to the Adult Intensive Care Unit post-operatively.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients will be excluded from the trial if they:
•are having repeat surgery,
•refuse consent,
•are contraindicated for pressor infusions,
•are not planned to be ventilated overnight

- are prisoners
- are unable to give consent.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: •Absolute change in transfer function (flap vascular resistance) after pressor infusion.;Secondary Objective: •Relative change in transfer function after pressor infusion compared with normal” tissue.<br>•Change in flap flow after pressor infusion.<br>•Differences in frequency spectrum of skin blood flow between flaps and normal” tissue before and after pressor infusion.<br>;Primary end point(s): To identify the optimal pharmacological agent for blood pressure maintenance after free tissue transfer surgery by investigating in the allocated random order, which of 4 commonly used and available licensed pressors achieves the best free flap blood flow as well as increasing blood pressure.

Secondary Outcome Measures