Optimal Tissue Perfusion
Conditions
Brief summary
Maintaining satisfactory tissue perfusion is an essential of success during reconstructive free flap surgery following malign oral cavity tumours. Intra- and postoperative goal-directed fluid therapy is an appropriate tool for that. Continuous cardiac output monitoring based fluid loading (complemented with vasopressor and/or inotropes if necessary) might be superior to conventional, central venous and arterial pressure monitoring in terms of morbidity, complications, optimal fluid balance and days spent in hospital. However, there is no data describing the effects of goal-directed fluid therapy (crystalloid or colloid) on microcirculation of free flaps implanted in the oral cavity during the post-operative period. The aim of this study is to observe the effects of continuous macrohaemodynamic monitoring based, goal-directed fluid therapy on microcirculation of forearm flaps during the perioperative period.
Interventions
OTHERFluid management
Primary fluid admission: 1 mL/bodyweight kg/ hour crystalloid. If Pulse pressure variation is lower than 10%; 250 mL/15 min of colloid or crystalloid is administered depending on randomization.
DRUGNorepinephrine
Norepinephrine is administered if Mean arterial pressure drops below 65 mmHg. Mean arterial pressure must be maintained above 65 mmHg. Norepinephrine is titrated accordingly.
DRUGDobutamine
Dobutamine is administered if Cardiac index drops below 2.5 L/min/m2. Cardiac index must be maintained above 2.5 L/min/m2. Dobutamine is titrated accordingly.
Sponsors
Department of Oral and Maxillofacial Surgery, University of Szeged
Institute of Surgical Research, University of Szeged
Szeged University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age over 18 * Tumour location: intraoral * Free flap type: radial forearm * Signed informed concent form
Exclusion criteria
* Vulnerable subject as defined in International Standards Organization 14155:2011 * End stage oral cancer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes of Pulse pressure variation during the operation and the post-operative 24 hours | 24 hours |
| Assesment of free falp microcirculation by laser dopler flowmetry method. | 24 hours |
| Total need of Norepinephrine and Dobutamine during surgery and the post-operative 24 hours. | 24 hours |
| Changes of Cardiac Index during the operation and the post-operative 24 hours. | 24 hours |
| Mean arterial pressure during the operation and the post-operative 24 hours. | 24 hours |
Secondary
| Measure | Time frame |
|---|---|
| Length of Intensive Care Unit stay | 24 hours |
| Number of surgical or non-surgical complications. | 24 hours |
| Length of Hospital stay | 10 days |
Countries
Hungary
Outcome results
None listed