Continuation of Goal Directed Haemodynamic Optimization in the PACU

University Hospital Schleswig-Holstein (UKSH)

Status: Completed

Conditions: Postoperative Complications; Ultrasound Imaging; Hemodynamic Instability

Treatments: Other: goal directed intraoperative haemodynamic optimization

Study type: Interventional

Funder types: Other

Identifiers

NCT04822116

IN-PACU-01

Details and patient eligibility

About

Post-operative monitoring of all patients after anaesthesia in the post anaesthesia care unit (PACU) is standard of care today. It helps to reduce morbidity and even mortality in high-risk patients.

In addition to clinical monitoring by qualified staff, standard monitoring in the PACU includes non-invasive, intermittent, haemodynamic monitoring.

This research is going to investigate the influence of the continuation of goal directed haemodynamic optimization in the recovery room on the basis of non-invasive monitoring tools, i.e. ultrasound and the volume-clamp method, in regard of length of stay in the PACU and postoperative complications.

Full description

Postoperative monitoring of all patients after surgery in post anaesthesia care unit (PACU) is standard of care today. It helps to reduce morbidity and even mortality in high-risk patients.

In addition to clinical monitoring by qualified staff, standard monitoring in the PACU includes non-invasive, intermittent, haemodynamic monitoring. The time of transfer of patients from the PACU to the general ward is assessed on the basis of several parameters. There is consensus on the most important endpoints of transferability: awareness, quality of spontaneous breathing, circulatory situation, bleeding situation, body temperature, diuresis and satisfactory freedom from pain and absence of nausea, but the processes and contents and how they can be established as quickly and sustainable as possible are not yet defined.

This research will investigate the influence of continuing non-invasive, goal-directed haemodynamic optimization in the recovery room, after major traumatological, general and vascular surgery.

In a randomized controlled trial the investigators will include a population of 80 patients with a minimum age of 18 years in the study after clarification and approval.

The control group will be routinely treated with an appropriate protocol for goal-oriented haemodynamic optimization. The study group will receive targeted haemodynamic optimization using Vigileo FlowTrac-Analysis and transthoracic echocardiography in the operation room and finger-cuff based pulse analysis technology in the PACU. The observed parameters of targeted haemodynamic optimization will be stroke volume and cardiac output, volume response parameters and collapsability of the inferior vena cava for the volume status.

As primary endpoints the investigators considered the number of postoperative complications. As secondary endpoints, the investigators will compare the time spent in the recovery room, the time spent in hospital and 28-day mortality and morbidity.

The hypothesis is that, in patients classified ASA II and III, a continuation of a targeted haemodynamic optimization in the PACU with non-invasive monitoring methods can reduce postoperative complications after a variety of surgical procedures.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients with ASA classification I-III undergoing abdominal surgery, surgery in urology or vascular surgery
• written consent

Exclusion criteria

• Age <18 years
• ASA classification IV or higher
• legal care relationship
• missing or faulty written consent

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

standard of care

No Intervention group

Description:

Standard of care defined as "standard operating procedure", including a goal directed intraoperative haemodynamic optimization protocol.

goal directed intraoperative haemodynamic optimization

Active Comparator group

Description:

Standard of care defined as "standard operating procedure", including a goal directed intraoperative haemodynamic optimization protocol. Additional application of a non-invasive haemodynamic optimization protocol in the post anaesthesia care unit.

Treatment:

Other: goal directed intraoperative haemodynamic optimization