Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-26 @ 11:49 AM
Ignite Modification Date:
2025-12-26 @ 11:49 AM
NCT ID:
NCT04822116
Brief Summary:
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.
Detailed 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.
Study:
NCT04822116
Study Brief:
Protocol Section:
NCT04822116