Hemodynamic InstabilityNCT04822116
Continuation of Goal Directed Haemodynamic Optimization in the PACU
A study testing goal directed intraoperative haemodynamic optimization in people with Hemodynamic Instability 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
- Hemodynamic Instability, Postoperative Complications, Ultrasound Imaging
- What is being tested?
- goal directed intraoperative haemodynamic optimization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- 24 Apr 2019to 1 Mar 2021
- Phase
- Interventional
- 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
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: Continuation of Goal Directed Haemodynamic Optimization in the Postanaesthesia Care Unit on the Basis of Non-invasive Methods: a Randomized Controlled Trial.
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.
Read the 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.
- Being tested
- goal directed intraoperative haemodynamic optimization
- Keywords
- Goal directed haemodynamic optimization, Ultrasound Imaging, Postoperative complications
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
goal directed intraoperative haemodynamic optimizationOther
Also called crystalloids, transthoracic echocardiography, volume clamp method
all interventions that were pre-specified to be administered as part of the protocol
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: goal directed intraoperative haemodynamic optimization |
What is being measured
The primary outcome is the main question the study is designed to answer.
acute kidney failure
Number of post-operative complications
Measured: through study completion, an average of 1 year
pulmonary oedema
Number of post-operative complications
Measured: through study completion, an average of 1 year
wound infection
Number of post-operative complications
Measured: through study completion, an average of 1 year
pneumonia
Number of post-operative complications
Measured: through study completion, an average of 1 year
Secondary outcomes (3)
length of stay in the PACU
through study completion
Measured: through study completion, an average of 1 year
length of stay in hospital
through study completion
Measured: through study completion, an average of 1 year
28-day survival
through study completion
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2021
- Study start24 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 (1)Papers the sponsor has linked to this study.
- Other trials for Hemodynamic InstabilityStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Investigator
- 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
- Investigators
- Jochen Renner, prof. Dr., Study chair, University Hospital Schleswig-Holstein, Kiel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04822116
- Sponsor's protocol ID
- IN-PACU-01
- Status last verified
- Mar 2021
- First submitted
- 21 Jun 2019
- Last updated
- 30 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; 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.
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuation of Goal Directed Haemodynamic Optimization in the Postanaesthesia Care Unit on the Basis of Non-invasive Methods: a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT04822116
- Acronym / sponsor ID
- IN-PACU-01
- Keywords
- Goal directed haemodynamic optimization, Ultrasound Imaging, Postoperative complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University Hospital Schleswig-HolsteinUniversity, hospital or other
- Study start
- 24 Apr 2019 (actual)
- Primary completion
- 31 Jan 2021 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 30 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 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: goal directed intraoperative haemodynamic optimizationStandard 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| goal directed intraoperative haemodynamic optimizationAlso: crystalloids, transthoracic echocardiography, volume clamp methodall interventions that were pre-specified to be administered as part of the protocol | Other | goal directed intraoperative haemodynamic optimization |
Primary outcome
acute kidney failure
Time frame: through study completion, an average of 1 year
Number of post-operative complications
pulmonary oedema
Time frame: through study completion, an average of 1 year
Number of post-operative complications
wound infection
Time frame: through study completion, an average of 1 year
Number of post-operative complications
pneumonia
Time frame: through study completion, an average of 1 year
Number of post-operative complications
3 secondary outcomes
length of stay in the PACU
Time frame: through study completion, an average of 1 year
length of stay in hospital
Time frame: through study completion, an average of 1 year
28-day survival
Time frame: through study completion, an average of 1 year
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 30 Mar 2021.
- BackgroundAldrete 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.
- Individual participant dataSharing planned: No
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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.
Jochen Renner, prof. Dr. study chair
University Hospital Schleswig-Holstein, Kiel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing goal directed intraoperative haemodynamic optimization in people with Hemodynamic Instability 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 30 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?
acute kidney failure (time frame: through study completion, an average of 1 year). 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 NCT04822116, which also lists 1 linked publication.
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 30 Mar 2021; AzTrials last refreshed its copy on 6 Nov 2026.