Continuation of Goal Directed Haemodynamic Optimization in the PACU

Not Applicable

Completed

• Conditions: Hemodynamic Instability; Ultrasound Imaging; Postoperative Complications
• Interventions: Other: goal directed intraoperative haemodynamic optimization

• Registration Number: NCT04822116
• Lead Sponsor: University Hospital Schleswig-Holstein

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 Timeline

• Study Start: 2019-04-24
• Study First Submitted: 2019-06-21
• Primary Completion: 2021-01-31
• Status Verified: 2021-03
• Study Completion: 2021-03-01
• Study First Submitted QC: 2021-03-25
• Last Update Submitted: 2021-03-25
• Study First Posted: 2021-03-30
• Last Update Posted: 2021-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
goal directed intraoperative haemodynamic optimization	goal directed intraoperative haemodynamic optimization	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.

Primary Outcome Measures

Name	Time	Method
pulmonary oedema	through study completion, an average of 1 year	Number of post-operative complications
acute kidney failure	through study completion, an average of 1 year	Number of post-operative complications
wound infection	through study completion, an average of 1 year	Number of post-operative complications
pneumonia	through study completion, an average of 1 year	Number of post-operative complications

Secondary Outcome Measures

Name	Time	Method
length of stay in the PACU	through study completion, an average of 1 year	through study completion
length of stay in hospital	through study completion, an average of 1 year	through study completion
28-day survival	through study completion, an average of 1 year	through study completion

Trial Locations

Locations (1)

Universitätsklinikum Schleswig-Holstein Campus Kiel - Klinik für Anästhesiologie und Operative Intensivmedizin; 🇩🇪 Kiel, Deutschland (deu), Germany