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Continuation of Goal Directed Haemodynamic Optimization in the PACU

Continuation of Goal Directed Haemodynamic Optimization in the Postanaesthesia Care Unit on the Basis of Non-invasive Methods: a Randomized Controlled Trial.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04822116
Enrollment
80
Registered
2021-03-30
Start date
2019-04-24
Completion date
2021-03-01
Last updated
2021-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemodynamic Instability, Postoperative Complications, Ultrasound Imaging

Keywords

Goal directed haemodynamic optimization, Ultrasound Imaging, Postoperative complications

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.

Interventions

OTHERgoal directed intraoperative haemodynamic optimization

all interventions that were pre-specified to be administered as part of the protocol

Sponsors

University Hospital Schleswig-Holstein
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)

Intervention model description

In the study group volume therapy is based on variables like stroke volume and/or diameter of vena cava inferior based on a goal directed haemodynamic optimization protocol.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
wound infectionthrough study completion, an average of 1 yearNumber of post-operative complications
acute kidney failurethrough study completion, an average of 1 yearNumber of post-operative complications
pulmonary oedemathrough study completion, an average of 1 yearNumber of post-operative complications
pneumoniathrough study completion, an average of 1 yearNumber of post-operative complications

Secondary

MeasureTime frameDescription
length of stay in hospitalthrough study completion, an average of 1 yearthrough study completion
28-day survivalthrough study completion, an average of 1 yearthrough study completion
length of stay in the PACUthrough study completion, an average of 1 yearthrough study completion

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026