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Continuation of Goal Directed Haemodynamic Optimization in the PACU

Primary Purpose

Hemodynamic Instability, Postoperative Complications, Ultrasound Imaging

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
goal directed intraoperative haemodynamic optimization
Sponsored by
University Hospital Schleswig-Holstein
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hemodynamic Instability focused on measuring Goal directed haemodynamic optimization, Ultrasound Imaging, Postoperative complications

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Universitätsklinikum Schleswig-Holstein Campus Kiel - Klinik für Anästhesiologie und Operative Intensivmedizin

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

standard of care

goal directed intraoperative haemodynamic optimization

Arm Description

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

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.

Outcomes

Primary Outcome Measures

acute kidney failure
Number of post-operative complications
pulmonary oedema
Number of post-operative complications
wound infection
Number of post-operative complications
pneumonia
Number of post-operative complications

Secondary Outcome Measures

length of stay in the PACU
through study completion
length of stay in hospital
through study completion
28-day survival
through study completion

Full Information

First Posted
June 21, 2019
Last Updated
March 25, 2021
Sponsor
University Hospital Schleswig-Holstein
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1. Study Identification

Unique Protocol Identification Number
NCT04822116
Brief Title
Continuation of Goal Directed Haemodynamic Optimization in the PACU
Official Title
Continuation of Goal Directed Haemodynamic Optimization in the Postanaesthesia Care Unit on the Basis of Non-invasive Methods: a Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
April 24, 2019 (Actual)
Primary Completion Date
January 31, 2021 (Actual)
Study Completion Date
March 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Schleswig-Holstein

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemodynamic Instability, Postoperative Complications, Ultrasound Imaging
Keywords
Goal directed haemodynamic optimization, Ultrasound Imaging, Postoperative complications

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Investigator
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
standard of care
Arm Type
No Intervention
Arm Description
Standard of care defined as "standard operating procedure", including a goal directed intraoperative haemodynamic optimization protocol.
Arm Title
goal directed intraoperative haemodynamic optimization
Arm Type
Active Comparator
Arm 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.
Intervention Type
Other
Intervention Name(s)
goal directed intraoperative haemodynamic optimization
Other Intervention Name(s)
crystalloids, transthoracic echocardiography, volume clamp method
Intervention Description
all interventions that were pre-specified to be administered as part of the protocol
Primary Outcome Measure Information:
Title
acute kidney failure
Description
Number of post-operative complications
Time Frame
through study completion, an average of 1 year
Title
pulmonary oedema
Description
Number of post-operative complications
Time Frame
through study completion, an average of 1 year
Title
wound infection
Description
Number of post-operative complications
Time Frame
through study completion, an average of 1 year
Title
pneumonia
Description
Number of post-operative complications
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
length of stay in the PACU
Description
through study completion
Time Frame
through study completion, an average of 1 year
Title
length of stay in hospital
Description
through study completion
Time Frame
through study completion, an average of 1 year
Title
28-day survival
Description
through study completion
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jochen Renner, prof. Dr.
Organizational Affiliation
University Hospital Schleswig-Holstein, Kiel
Official's Role
Study Chair
Facility Information:
Facility Name
Universitätsklinikum Schleswig-Holstein Campus Kiel - Klinik für Anästhesiologie und Operative Intensivmedizin
City
Kiel
State/Province
Deutschland (deu)
ZIP/Postal Code
24105
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
Aldrete JA, Kroulik D A postanesthetic recovery score. Anesth Analg 1970; 49: 924-34. McLaren JM, Reynolds JA, Cox MM, et al. Decreasing the length of stay in phase I postanesthesia care unit: an evidence-based approach. J Perianesth Nurs 2015; 30: 116-23. Ameloot K, Van De Vijver K, Van Regenmortel N, et al. Validation study of Nexfin(R) continuous non-invasive blood pressure monitoring in critically ill adult patients. Minerva Anestesiol 2014; 80: 1294-301. Batz G, Dinkel M [Hemodynamic monitoring - imaging procedures / cardiac ultrasound]. Anasthesiol Intensivmed Notfallmed Schmerzther 2016; 51: 626-34. White PF, Song D New criteria for fast-tracking after outpatient anesthesia: a comparison with the modified Aldrete's scoring system. Anesth Analg 1999; 88: 1069-72. Broch O, Carstens A, Gruenewald M, et al. Non-invasive hemodynamic optimization in major abdominal surgery: a feasibility study. Minerva Anestesiol 2016; 82: 1158-69.
Results Reference
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Continuation of Goal Directed Haemodynamic Optimization in the PACU

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