Continuation of Goal Directed Haemodynamic Optimization in the PACU

NCT04822116 | Completed

• 1 other identifier: IN-PACU-01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemodynamic Instability; Postoperative Complications; Ultrasound Imaging

Keywords

Goal directed haemodynamic optimization; Ultrasound Imaging; Postoperative complications

Outcome Measures

Primary Outcomes (4)

• acute kidney failure

  Number of post-operative complications

  through study completion, an average of 1 year

• pulmonary oedema

  Number of post-operative complications

  through study completion, an average of 1 year

• wound infection

  Number of post-operative complications

  through study completion, an average of 1 year

• pneumonia

  Number of post-operative complications

  through study completion, an average of 1 year

Secondary Outcomes (3)

• length of stay in the PACU

  through study completion, an average of 1 year

• length of stay in hospital

  through study completion, an average of 1 year

• 28-day survival

  through study completion, an average of 1 year

Study Arms (2)

standard of care

NO INTERVENTION

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

goal directed intraoperative haemodynamic optimization

ACTIVE COMPARATOR

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.

Other: goal directed intraoperative haemodynamic optimization

Interventions

goal directed intraoperative haemodynamic optimization OTHER

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

Also known as: crystalloids, transthoracic echocardiography, volume clamp method

goal directed intraoperative haemodynamic optimization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with ASA classification I-III undergoing abdominal surgery, surgery in urology or vascular surgery
• written consent

You may not qualify if:

• Age \<18 years
• ASA classification IV or higher
• legal care relationship
• missing or faulty written consent

Sponsors & Collaborators

• University Hospital Schleswig-Holstein: lead

Study Sites (1)

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

Kiel, Deutschland (deu), 24105, Germany

Location

Related Publications (1)

• 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.

  BACKGROUND

MeSH Terms

Conditions

Postoperative Complications

Interventions

Crystalloid Solutions

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Jochen Renner, prof. Dr.

  University Hospital Schleswig-Holstein, Kiel

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: 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.

Study Record Dates

• First Submitted: June 21, 2019
• First Posted: March 30, 2021
• Study Start: April 24, 2019
• Primary Completion: January 31, 2021
• Study Completion: March 1, 2021
• Last Updated: March 30, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)