Intraoperative hypotension Surgery
Conditions
Interventions
This will be a prospective non-randomised trial with three sequential cohorts of 50 patients. The first cohort will act as the control group representing standard practice at the institution, whilst t
Sponsors
York Teaching Hospital NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients due to undergo elective major abdominal, orthopaedic, head and neck or vascular surgery requiring invasive arterial monitoring (decided at the discretion of the treating clinician) under general anaesthesia with positive pressure ventilation, and with an expected duration of greater than 90 minutes, who will have goal-directed fluid therapy performed as part of their standard care 2. Clinicians and other allied medical staff will be included in the qualitative study on the basis that they are involved in the care of patients meeting the above criteria and are willing to participate in the structured interviews and questionnaires
Exclusion criteria
Exclusion criteria: 1. Requirement for an intraoperative mean arterial pressure of greater than 65mmHg as decided by the treating surgeon and/or anaesthetist 2. A preoperative MAP of lower than 65 mmHg documented on 2 separate occasions at preoperative assessment clinic 3. Significant right or left ventricular heart failure 4. Known intracardiac shunt 5. Known severe aortic stenosis (peak velocity greater than 4m per second and/or aortic valve area less than 1 cm2) 6. Cardiac arrhythmias 7. Planned positive pressure ventilation with tidal volume < 7 ml/kg 8. Hepatic surgery 9. Subjects requiring dialysis 10. Subjects who do not have the capacity to consent 11. Subjects aged less than 18 years of age
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Social-cognitive determinants of behaviour change including attitudes, self-efficacy, social norms, skills, as well as factors relating to the normalisation of technology into routine practice, assessed through qualitative data analysis of interviews and questionnaires across the study at different timepoints (end of phase 1, 2 and 3) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Treatment of hypotension in the different cohorts, measured at the end of surgery, analysis after cohort 3 2. Incidence of hypotension (defined as no of episodes with MAP <65 mmHg) in each cohort, measured the end of surgery, analysis after cohort 3 3. Time weighted average spent in hypotension between cohorts, measured at the end of surgery 4. Proportion of interventions deemed suboptimal to treat hypotension, measured at the end of each cohort 5. Effects of interventions (fluid, vasopressors and inotropes) on secondary parameters including SVV, PPV, CI, SVI, Eadyn and dP/dT, measured at the end of surgery, analysis after cohort 3 6. Health psychology analysis, measured at the end of surgery, analysis after cohort 3 | — |
Countries
England, United Kingdom
Outcome results
None listed