Feasibility of Extended Non-invasive Haemodynamic Monitoring in the PACU

Postoperative Complications Clinical Trial

Official title:

Prospective Observational Study on the Use of Extended Haemodynamic Monitoring in the Post-Anesthesia Care Unit (PACU) Using Non-invasive Methods: Feasibility and Influence on Volume Therapy and Catecholamine Treatment.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04814966
• Other study ID #: IN-PACU-02
• Status: Completed
• Start date: April 1, 2019
• Est. completion date: March 1, 2021

Study information

• Verified date: March 2021
• Source: University Hospital Schleswig-Holstein
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Postoperative haemodynamic management, with particular emphasis on adequate volume status, is essential for patient outcome, as is optimised intraoperative management. Postoperative monitoring is usually performed in the PACU by non-invasive, continuous and intermittent monitoring. ECG and oxygen saturation are monitored continuously, blood pressure and laboratory analyses intermittently. The assessment of adequate oxygen supply (cardiac output - haemoglobin concentration - oxygen saturation) in the PACU is traditionally approximated only by surrogate parameters such as blood pressure and heart rate, in the sense of an empirical approach. The aim should be to transfer the available data on the benefit of early, goal-oriented haemodynamic optimisation by means of extended haemodynamic monitoring to the sensitive area of the PACU. An important prerequisite for the implementation of such haemodynamic optimisation protocols is the use of non-invasive monitoring methods, which ideally provide continuous flow and pressure-based parameters in combination with the use of intermittent transthoracic echocardiography. The necessity to continue extended haemodynamic monitoring in selected patients in the PACU on the basis of non-invasive procedures is under discussion and is not part of a defined standard today (Gruenewald et al. Anaesthesia 2015). A number of non-invasive haemodynamic monitoring methods have become available over the last few years, with a large number of scientific evaluation studies investigating the methods in various clinical settings in comparison to invasive systems. Of interest for routine clinical use are the so-called volume clamp procedures, which allow non-invasive, continuous recording of haemodynamic parameters such as stroke volume, cardiac output, blood pressure and plus pressure variation. Thus, in combination with oxygen saturation and intermittent haemoglobin determinations, they enable a punctual determination of oxygen supply (Meidert et al. Front Med (Lausanne) 2017 and Renner et al. Br J Anaesth 2017). It is of interest whether the volume clamp method in particular provides the aforementioned parameters such as blood pressure, stroke volume, cardiac output and the pulse pressure variation continuously and without interference in the awake patient in the PACU. Another aspect is the assessment of the volume status and cardiac performance that patients show on admission to the PACU. Here, special attention is paid to the volume status after the patients have been haemodynamically optimised intraoperatively with an invasive procedure. Furthermore, we will compare how the cardiac output determined by echocardiography on admission differs from the cardiac output of the volume clamp method on admission. The differences between invasive blood pressure measurement and non-invasive pressure measurement will also be assessed. In addition, the investigators analyse the frequencies of decreased blood pressures in comparison to a patient collective that was monitored according to standard-of-care in the PACU. Also, the comparative observation of the number of interventions performed, such as volume administration and/or catecholamine administration, between the groups.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: March 1, 2021
• Est. primary completion date: January 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Complications
• Goal Directed Therapy
• Postoperative Complications
• Ultrasound Therapy

Locations

Country	Name	City	State
Germany	Universitätsklinikum Schleswig-Holstein Campus Kiel - Klinik für Anästhesiologie und Operative Intensivmedizin	Kiel	Deutschland (deu)

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Schleswig-Holstein

Country where clinical trial is conducted

Germany, 

References & Publications (17)

Aldrete JA, Kroulik D. A postanesthetic recovery score. Anesth Analg. 1970 Nov-Dec;49(6):924-34. — View Citation

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® continuous non-invasive blood pressure monitoring in critically ill adult patients. Minerva Anestesiol. 2014 Dec;80(12):1294-301. Epub 2014 Apr 4. — View Citation

Batz G, Dinkel M. [Hemodynamic monitoring - imaging procedures / cardiac ultrasound]. Anasthesiol Intensivmed Notfallmed Schmerzther. 2016 Oct;51(10):626-634. Epub 2016 Oct 20. Review. German. — View Citation

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. — View Citation

Broch O, Renner J, Gruenewald M, Meybohm P, Schöttler J, Caliebe A, Steinfath M, Malbrain M, Bein B. A comparison of the Nexfin® 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. — View Citation

Eichenberger AS, Haller G, Cheseaux N, Lechappe V, Garnerin P, Walder B. A clinical pathway in a post-anaesthesia care unit to reduce length of stay, mortality and unplanned intensive care unit admission. Eur J Anaesthesiol. 2011 Dec;28(12):859-66. doi: 10.1097/EJA.0b013e328347dff5. — View Citation

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. — View Citation

Jain A, Muralidhar V, Aneja S, Sharma AK. A prospective observational study comparing criteria-based discharge method with traditional time-based discharge method for discharging patients from post-anaesthesia care unit undergoing ambulatory or outpatient minor surgeries under general anaesthesia. Indian J Anaesth. 2018 Jan;62(1):61-65. doi: 10.4103/ija.IJA_549_17. — View Citation

McLaren JM, Reynolds JA, Cox MM, Lyall JS, McCarthy M, McNoble EM, Petersen VR. Decreasing the length of stay in phase I postanesthesia care unit: an evidence-based approach. J Perianesth Nurs. 2015 Apr;30(2):116-23. doi: 10.1016/j.jopan.2014.05.010. — View Citation

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. Review. — View Citation

Pouwels S, Lascaris B, Nienhuijs SW, Arthur Bouwman R, Buise MP. Validation of the Nexfin® 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	length of stay in the recovery room	evaluated using the Whites-Fast-Trac Scoring System	up to 24 weeks
Primary	acute renal failure	number of short-term postoperative complications	up to 24 weeks
Primary	pericardial effusion	number of short-term postoperative complications	up to 24 weeks
Primary	pulmonary oedema	number of short-term postoperative complications	up to 24 weeks
Secondary	cardiac output by echocardiography	cardiac output determined by echocardiography on admission	up to 24 weeks
Secondary	cardiac output volume clamp method	cardiac output determined by volume clamp method on admission	up to 24 weeks
Secondary	frequencies of decreased blood pressure values	frequencies of decreased blood pressure values between the groups	up to 24 weeks
Secondary	number of interventions	comparative observation of the number of interventions performed between the groups	up to 24 weeks