Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04822116 |
Other study ID # |
IN-PACU-01 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
April 24, 2019 |
Est. completion date |
March 1, 2021 |
Study information
Verified date |
March 2021 |
Source |
University Hospital Schleswig-Holstein |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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.