Feasibility of Extended Non-invasive Haemodynamic Monitoring in the PACU

NCT04814966 | Completed

• 1 other identifier: IN-PACU-02
• Study Type: observational
• 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 personnel, this monitoring also includes, commonly non-invasive, intermittent, haemodynamic monitoring. This monitoring is also used to evaluate the transferability of patients from the PACU to the ward. The aim of our study is to perform extended monitoring of volume status and haemodynamics with non-invasive monitoring methods such as transthoracic echocardiography and the volume clamp method in the recovery room.

Conditions

Goal Directed Therapy; Postoperative Complications; Complications; Ultrasound Therapy

Keywords

Goal directed haemodynamic optimization; Ultrasound Therapy; Postoperative complications

Outcome Measures

Primary Outcomes (4)

• length of stay in the recovery room

  evaluated using the Whites-Fast-Trac Scoring System

  up to 24 weeks

• acute renal failure

  number of short-term postoperative complications

  up to 24 weeks

• pericardial effusion

  number of short-term postoperative complications

  up to 24 weeks

• pulmonary oedema

  number of short-term postoperative complications

  up to 24 weeks

Secondary Outcomes (4)

• cardiac output by echocardiography

  up to 24 weeks

• cardiac output volume clamp method

  up to 24 weeks

• frequencies of decreased blood pressure values

  up to 24 weeks

• number of interventions

  up to 24 weeks

Eligibility Criteria

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

Study Population

patients with ASA classification I-III undergoing abdominal surgery, surgery in urology or vascular surgery and delivered to postanaesthesia care unit

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 (17)

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  PMID: 5534693 BACKGROUND

• Truong L, Moran JL, Blum P. Post anaesthesia care unit discharge: a clinical scoring system versus traditional time-based criteria. Anaesth Intensive Care. 2004 Feb;32(1):33-42. doi: 10.1177/0310057X0403200106.

  PMID: 15058119 BACKGROUND

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  PMID: 25813297 BACKGROUND

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  PMID: 29416152 BACKGROUND

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  PMID: 21885983 BACKGROUND

• Waddle JP, Evers AS, Piccirillo JF. Postanesthesia care unit length of stay: quantifying and assessing dependent factors. Anesth Analg. 1998 Sep;87(3):628-33. doi: 10.1097/00000539-199809000-00026.

  PMID: 9728843 BACKGROUND

• Samad K, Khan M, Hameedullah, Khan FA, Hamid M, Khan FH. Unplanned prolonged postanaesthesia care unit length of stay and factors affecting it. J Pak Med Assoc. 2006 Mar;56(3):108-12.

  PMID: 16696508 BACKGROUND

• Ameloot K, Van De Vijver K, Van Regenmortel N, De Laet I, Schoonheydt K, Dits H, Broch O, Bein B, Malbrain ML. Validation study of Nexfin(R) continuous non-invasive blood pressure monitoring in critically ill adult patients. Minerva Anestesiol. 2014 Dec;80(12):1294-301. Epub 2014 Apr 4.

  PMID: 24705004 BACKGROUND

• Batz G, Dinkel M. [Hemodynamic monitoring - imaging procedures / cardiac ultrasound]. Anasthesiol Intensivmed Notfallmed Schmerzther. 2016 Oct;51(10):626-634. doi: 10.1055/s-0041-110009. Epub 2016 Oct 20. German.

  PMID: 27764871 BACKGROUND

• Broch O, Renner J, Gruenewald M, Meybohm P, Schottler J, Caliebe A, Steinfath M, Malbrain M, Bein B. A comparison of the Nexfin(R) and transcardiopulmonary thermodilution to estimate cardiac output during coronary artery surgery. Anaesthesia. 2012 Apr;67(4):377-83. doi: 10.1111/j.1365-2044.2011.07018.x. Epub 2012 Feb 11.

  PMID: 22324797 BACKGROUND

• Pouwels S, Lascaris B, Nienhuijs SW, Arthur Bouwman R, Buise MP. Validation of the Nexfin(R) non-invasive continuous blood pressure monitoring validated against Riva-Rocci/Korotkoff in a bariatric patient population. J Clin Anesth. 2017 Jun;39:89-95. doi: 10.1016/j.jclinane.2017.03.029. Epub 2017 Mar 31.

  PMID: 28494917 BACKGROUND

• White PF, Song D. New criteria for fast-tracking after outpatient anesthesia: a comparison with the modified Aldrete's scoring system. Anesth Analg. 1999 May;88(5):1069-72. doi: 10.1097/00000539-199905000-00018. No abstract available.

  PMID: 10320170 BACKGROUND

• Broch O, Carstens A, Gruenewald M, Nischelsky E, Vellmer L, Bein B, Aselmann H, Steinfath M, Renner J. Non-invasive hemodynamic optimization in major abdominal surgery: a feasibility study. Minerva Anestesiol. 2016 Nov;82(11):1158-1169. Epub 2016 Jun 28.

  PMID: 27352070 BACKGROUND

• Salzwedel C, Puig J, Carstens A, Bein B, Molnar Z, Kiss K, Hussain A, Belda J, Kirov MY, Sakka SG, Reuter DA. Perioperative goal-directed hemodynamic therapy based on radial arterial pulse pressure variation and continuous cardiac index trending reduces postoperative complications after major abdominal surgery: a multi-center, prospective, randomized study. Crit Care. 2013 Sep 8;17(5):R191. doi: 10.1186/cc12885.

  PMID: 24010849 BACKGROUND

• Gruenewald M, Renner J. Do we need to monitor cardiac output in spontaneously breathing patients? Anaesthesia. 2015 Feb;70(2):122-5. doi: 10.1111/anae.12951. No abstract available.

  PMID: 25583187 BACKGROUND

• Meidert AS, Saugel B. Techniques for Non-Invasive Monitoring of Arterial Blood Pressure. Front Med (Lausanne). 2018 Jan 8;4:231. doi: 10.3389/fmed.2017.00231. eCollection 2017.

  PMID: 29359130 BACKGROUND

• Renner J, Gruenewald M, Hill M, Mangelsdorff L, Aselmann H, Ilies C, Steinfath M, Broch O. Non-invasive assessment of fluid responsiveness using CNAP technology is interchangeable with invasive arterial measurements during major open abdominal surgery. Br J Anaesth. 2017 Jan;118(1):58-67. doi: 10.1093/bja/aew399.

  PMID: 28039242 BACKGROUND

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: July 16, 2019
• First Posted: March 24, 2021
• Study Start: April 1, 2019
• Primary Completion: January 31, 2021
• Study Completion: March 1, 2021
• Last Updated: March 24, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)