AnaesthesiaNCT03136614
Prognostic Value of the Arteriograph in the Surgical Theatre and at the Intensive Care Unit
A study testing Arteriograph in people with Anaesthesia, run by Szeged University at 1 site in Hungary.
Trial summary
To investigate how pulse wave velocity, aortic augmentation index and the arterial pulse wave given by the Arteriograph contributes to preoperative assesment, intraoperative and intensive care monitoring. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Anaesthesia
- What is being tested?
- Arteriograph
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteHungary
- Study dates
- Jun 2016to Dec 2017
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For the "preoperative" arm:
- Signed informed consent form
- Arterial catheter for hemodynamic monitoring
- For the "intraoperative" arm:
- Signed informed consent form
- Arterial catheter for hemodynamic monitoring
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- The operation will presumably last for more than 2 hours
- For the "intensive care unit" arm:
- Signed informed consent form
- PiCCO monitor for hemodynamic monitoring
Who cannot join
- For the "preoperative" arm:
- Pregnancy
- Subject belongs to a vulnerable group (ISO 14155:2011) e.g.: study member, medical student
- For the "intraoperative" arm:
- Pregnancy
- Subject belongs to a vulnerable group (ISO 14155:2011) e.g.: study member, medical student
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- Measuring blood pressure on both arms is not possible
- Insertion of an arterial catheter is not necessary or contraindicated
- Insertion of a central venous catheter is not necessary or contraindicated
- For the "intensive care unit" arm:
- Pregnancy
- Subject belongs to a vulnerable group (ISO 14155:2011) e.g.: study member, medical student
Trial locations and contacts
1 site in 1 country.
Hungary1 site, 1 recruiting
- Recruiting
Department of Anaesthesiology and Intensive Therapy
Szeged, Csongrád megye, 6725
Petra Dalmann, +36 62 - 545 168, office.aiti@med.u-szeged.hu
About this study
To investigate how pulse wave velocity, aortic augmentation index and the arterial pulse wave given by the Arteriograph contributes to preoperative assesment, intraoperative and intensive care monitoring.
- Conditions
- Anaesthesia
- Being tested
- Arteriograph
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArteriographDevice
| Study group | Role | What they receive |
|---|---|---|
| Preoperative | Active comparator | A single measurement with an Arteriograph is performed a day before an elective surgical intervention. Receives: Device: Arteriograph |
| Intraoperative | Active comparator | An arteriograph is put on the patient for the time of operation. The device is set to measure in every 5 minutes. Receives: Device: Arteriograph |
| Intensive Care Unit | Active comparator | Three separate measurements are performed on the subject with an Arteriograph throughout every dayshift for 3 days. Receives: Device: Arteriograph |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and degree of hypotensive episodes predicted by preoperative values of pulse wave velocity.
The investigators will examine if high values of pulse wave velocity correlate with the frequency and severity of hypotensive episodes under anaesthesia.
Measured: One year
Correlation between systemic vascular resistance and aortic augmentation index
Measured: One year
Identity of cardiac output given by the PiCCO monitor and cardiac output given by the Arteriograph
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2017
- Study startJun 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnaesthesiaStudies 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
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Szeged University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zsolt Molnár, MD, PhD, DEAA, Szeged University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03136614
- Sponsor's protocol ID
- Arteriograph-2016
- Status last verified
- Aug 2017
- First submitted
- 20 Feb 2017
- Last updated
- 30 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of the Arteriograph in the Surgical Theatre and at the Intensive Care Unit
- ClinicalTrials.gov ID
- NCT03136614
- Acronym / sponsor ID
- Arteriograph-2016
- Conditions
- Anaesthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Szeged UniversityUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 2 May 2017 (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.
To investigate how pulse wave velocity, aortic augmentation index and the arterial pulse wave given by the Arteriograph contributes to preoperative assesment, intraoperative and intensive care monitoring.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Preoperative | Active comparator | Device: ArteriographA single measurement with an Arteriograph is performed a day before an elective surgical intervention. |
| Intraoperative | Active comparator | Device: ArteriographAn arteriograph is put on the patient for the time of operation. The device is set to measure in every 5 minutes. |
| Intensive Care Unit | Active comparator | Device: ArteriographThree separate measurements are performed on the subject with an Arteriograph throughout every dayshift for 3 days. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Signed informed consent form
- Arterial catheter for hemodynamic monitoring
- Signed informed consent form
- Arterial catheter for hemodynamic monitoring
- The operation will presumably last for more than 2 hours
Key exclusion criteria (12 listed)
- Pregnancy
- Subject belongs to a vulnerable group (ISO 14155:2011) e.g.: study member, medical student
- Pregnancy
- Subject belongs to a vulnerable group (ISO 14155:2011) e.g.: study member, medical student
- Measuring blood pressure on both arms is not possible
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 |
|---|---|---|
| Arteriograph | Device | Intensive Care Unit, Intraoperative, Preoperative |
Primary outcome
Number and degree of hypotensive episodes predicted by preoperative values of pulse wave velocity.
Time frame: One year
The investigators will examine if high values of pulse wave velocity correlate with the frequency and severity of hypotensive episodes under anaesthesia.
Correlation between systemic vascular resistance and aortic augmentation index
Time frame: One year
Identity of cardiac output given by the PiCCO monitor and cardiac output given by the Arteriograph
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2017.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
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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.
Department of Anaesthesiology and Intensive Therapy
Szeged, Hungary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arteriograph in people with Anaesthesia, run by Szeged University at 1 site in Hungary.
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 10 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 30 Aug 2017. 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 Hungary. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and degree of hypotensive episodes predicted by preoperative values of pulse wave velocity. (time frame: One year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Aug 2017.