Goal Directed TherapyNCT04814966
Feasibility of Extended Non-invasive Haemodynamic Monitoring in the PACU
An observational study of Goal Directed Therapy and Postoperative Complications, run by University Hospital Schleswig-Holstein at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Goal Directed Therapy, Postoperative Complications, Complications
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- 1 Apr 2019to 1 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with ASA classification I-III undergoing abdominal surgery, surgery in urology or vascular surgery and delivered to postanaesthesia care unit
Who may be able to join
- patients with ASA classification I-III undergoing abdominal surgery, surgery in urology or vascular surgery
- written consent
Who cannot join
- Age <18 years
- ASA classification IV or higher
- legal care relationship
- missing or faulty written consent
Trial locations and contacts
1 site in 1 country.
Germany1 site
Universitätsklinikum Schleswig-Holstein Campus Kiel - Klinik für Anästhesiologie und Operative Intensivmedizin
Kiel, Deutschland (deu), 24105
About this study
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.
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.
Read the detailed 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.
- Keywords
- Goal directed haemodynamic optimization, Ultrasound Therapy, Postoperative complications
- Medical subject headings
- Postoperative Complications
What is being measured
The primary outcome is the main question the study is designed to answer.
length of stay in the recovery room
evaluated using the Whites-Fast-Trac Scoring System
Measured: up to 24 weeks
acute renal failure
number of short-term postoperative complications
Measured: up to 24 weeks
pericardial effusion
number of short-term postoperative complications
Measured: up to 24 weeks
pulmonary oedema
number of short-term postoperative complications
Measured: up to 24 weeks
Secondary outcomes (4)
cardiac output by echocardiography
cardiac output determined by echocardiography on admission
Measured: up to 24 weeks
cardiac output volume clamp method
cardiac output determined by volume clamp method on admission
Measured: up to 24 weeks
frequencies of decreased blood pressure values
frequencies of decreased blood pressure values between the groups
Measured: up to 24 weeks
number of interventions
comparative observation of the number of interventions performed between the groups
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study start1 Apr 2019
- Primary completion31 Jan 2021
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Goal Directed TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Schleswig-Holstein
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Jochen Renner, University Hospital Schleswig-Holstein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04814966
- Sponsor's protocol ID
- IN-PACU-02
- Status last verified
- Mar 2021
- First submitted
- 16 Jul 2019
- Last updated
- 24 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aldrete JA, Kroulik D. A postanesthetic recovery score. Anesth Analg. 1970 Nov-Dec;49(6):924-34. No abstract available.
PubMed 5534693Truong 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.
PubMed 15058119McLaren 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.
PubMed 25813297Jain 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.
PubMed 29416152Eichenberger 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.
PubMed 21885983Waddle 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.
PubMed 9728843Samad 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.
PubMed 16696508Ameloot 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.
PubMed 24705004Batz 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.
PubMed 27764871Broch 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.
PubMed 22324797Pouwels 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.
PubMed 28494917White 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.
PubMed 10320170Broch 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.
PubMed 27352070Salzwedel 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.
PubMed 24010849Gruenewald 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.
PubMed 25583187
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04814966
- Acronym / sponsor ID
- IN-PACU-02
- Keywords
- Goal directed haemodynamic optimization, Ultrasound Therapy, Postoperative complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University Hospital Schleswig-HolsteinUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 31 Jan 2021 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 24 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with ASA classification I-III undergoing abdominal surgery, surgery in urology or vascular surgery and delivered to postanaesthesia care unit
Key inclusion criteria (2 listed)
- patients with ASA classification I-III undergoing abdominal surgery, surgery in urology or vascular surgery
- written consent
Key exclusion criteria (4 listed)
- Age <18 years
- ASA classification IV or higher
- legal care relationship
- missing or faulty written consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
length of stay in the recovery room
Time frame: up to 24 weeks
evaluated using the Whites-Fast-Trac Scoring System
acute renal failure
Time frame: up to 24 weeks
number of short-term postoperative complications
pericardial effusion
Time frame: up to 24 weeks
number of short-term postoperative complications
pulmonary oedema
Time frame: up to 24 weeks
number of short-term postoperative complications
4 secondary outcomes
cardiac output by echocardiography
Time frame: up to 24 weeks
cardiac output volume clamp method
Time frame: up to 24 weeks
frequencies of decreased blood pressure values
Time frame: up to 24 weeks
number of interventions
Time frame: up to 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2021.
- Background: PubMed 5534693Aldrete JA, Kroulik D. A postanesthetic recovery score. Anesth Analg. 1970 Nov-Dec;49(6):924-34. No abstract available.
- Background: PubMed 15058119Truong 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.
- Background: PubMed 25813297McLaren 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.
- Background: PubMed 29416152Jain 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.
- Background: PubMed 21885983Eichenberger 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.
- Background: PubMed 9728843Waddle 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.
- Background: PubMed 16696508Samad 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.
- Background: PubMed 24705004Ameloot 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.
- Background: PubMed 27764871Batz 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.
- Background: PubMed 22324797Broch 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.
- Background: PubMed 28494917Pouwels 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.
- Background: PubMed 10320170White 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.
- Individual participant dataSharing planned: No
Related trials for Goal Directed Therapy
Not yet recruitingObservational study
Fluid Responsiveness in Laparoscopic Surgery: End-Expiratory Occlusion Test Versus Mini-Fluid Challenge
Fluid Responsiveness, Laparoscopic Surgery
Not yet recruiting
Low-Dose Norepinephrine With Conservative Fluid Therapy in Hepatobiliary Surgery
Postoperative Complications, Pulmonary Complication
Not yet recruiting
Prophylactic Norepinephrine for Prevention of Acute Kidney Injury in Living-Donor Liver Transplantation
Noradrenaline
Recruiting
Effects of GDHT (Goal Directed Hemodynamic Therapy) Using a Non-invasive Hemodynamic Monitoring in Elective Neurosurgery
Surgery Complications
Not yet recruiting
Passive Versus Active Music Therapy Parkinson's Disease
Parkinson Disease (PD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Goal Directed Therapy and Postoperative Complications, run by University Hospital Schleswig-Holstein at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
length of stay in the recovery room (time frame: up to 24 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04814966, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2021.