Hemodynamic Instability During AnesthesiaNCT01811914
Focused TTE for Hemodynamic Instable High Risk Patients
A study testing intraoperative TTE in people with Hemodynamic Instability During Anesthesia and High Risk Surgery, run by Philipps University Marburg at 1 site in Germany.
Trial summary
Focused transthoracic echocardiography (TTE) is a technique, which allows quick and non-invasive diagnosis and monitoring in hemodynamic instable patients. There are preliminary data supporting the hypothesis that TTE is feasible in the operating theatre. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodynamic Instability During Anesthesia, High Risk Surgery
- What is being tested?
- intraoperative TTE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2013to Mar 2014
- 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
- gender: male, female
- Age ≥ 18 years
- increased perioperative risk, at least one of the following:
- coronary artery disease
- congestive heart disease
- insulin dependent diabetes mellitus
Show all 19Show fewer
- renal insufficiency, creatinine > 2,0 mg/dl
- cerebrovascular disease
- Sepsis
- Procedure with at least moderate increased risk
- intraperitoneal surgery
- intrathoracal surgery
- major orthopedic/traumatologic surgery
- prostatic surgery
- vascular surgery
- Hemodynamic instability, at least one of the following:
- Hypotension (systolic blood pressure < 80 mmHg or mean blood pressure <50 mmHg) and/or
- Bradycardia < 45/min. orr Tachycardia > 120/min and/or
- Cardiac index < 2,0 l/min/m2
Who cannot join
- cardiac surgery
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital of Marburg, Department of Anesthesia
Marburg, D-35033
About this study
Official title: Intraoperative Focused TTE - Impact on High Risk Patients´ Management in Hemodynamic Instabilities
Focused transthoracic echocardiography (TTE) is a technique, which allows quick and non-invasive diagnosis and monitoring in hemodynamic instable patients. There are preliminary data supporting the hypothesis that TTE is feasible in the operating theatre.
The purpose of this study is to test the hypothesis that intraoperative focused TTE has an impact on high risk patients´ management when it is added to standard extended monitoring practices in hemodynamic instabilities.
Read the detailed description
Focused TTE is en emerging matter in anesthesia, intensive care and emergency medicine. The value of intraoperative TTE is unclear. There are preliminary data that it is feasible For intraoperative transesophageal echocardiography (TEE) an impact on cardiac and non-cardiac surgery patients´ management has been shown.
Purpose of this study is to evaluate the application of focused TTE in patients with increased perioperative risk undergoing moderate to high risk surgery who become hemodynamic instable during anesthesia in the operating theatre.
When hemodynamic instability under anesthesia occurs focused TTE is conducted and the obtained diagnostic information are used for further patient management. Any change in management or therapy will be recorded.
- Being tested
- intraoperative TTE
- Keywords
- focused TTE, intraoperative TTE, transthoracic echocardiography, high risk non-cardiac surgery, hemodynamic instabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intraoperative TTEOther
Also called focused transthoracic echocardiography, focused TTE, intraoperative transthoracic echocardiography
| Study group | Role | What they receive |
|---|---|---|
| intraoperative TTE | Experimental | TTE if a hemodynamic instability occurs Receives: Other: intraoperative TTE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of patients´ management
Recordings of TTE findings influencing change of patient´s management in the operating theatre
Measured: at time of anesthesia / surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionNov 2013
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodynamic Instability During AnesthesiaStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philipps University Marburg
- Sponsor type
- University, hospital or other
- Collaborators
- Kerckhoff Heart Center
- Responsible party
- Principal investigator, Dr. Thomas Kratz, Philipps University Marburg
- Investigators
- Thomas Kratz, MD, Principal investigator, Department of Anesthesia and Intensive Care Medicine, University Hospital Marburg, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01811914
- Sponsor's protocol ID
- UKGMTTE4
- Status last verified
- Apr 2014
- First submitted
- 13 Mar 2013
- Last updated
- 17 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Focused TTE - Impact on High Risk Patients´ Management in Hemodynamic Instabilities
- ClinicalTrials.gov ID
- NCT01811914
- Acronym / sponsor ID
- UKGMTTE4
- Keywords
- focused TTE, intraoperative TTE, transthoracic echocardiography, high risk non-cardiac surgery, hemodynamic instabilities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Philipps University MarburgUniversity, hospital or other
- Collaborators
- Kerckhoff Heart Center
- Study start
- Mar 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 15 Mar 2013 (estimated)
- 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.
Focused transthoracic echocardiography (TTE) is a technique, which allows quick and non-invasive diagnosis and monitoring in hemodynamic instable patients. There are preliminary data supporting the hypothesis that TTE is feasible in the operating theatre.
The purpose of this study is to test the hypothesis that intraoperative focused TTE has an impact on high risk patients´ management when it is added to standard extended monitoring practices in hemodynamic instabilities.
Detailed description
Focused TTE is en emerging matter in anesthesia, intensive care and emergency medicine. The value of intraoperative TTE is unclear. There are preliminary data that it is feasible For intraoperative transesophageal echocardiography (TEE) an impact on cardiac and non-cardiac surgery patients´ management has been shown.
Purpose of this study is to evaluate the application of focused TTE in patients with increased perioperative risk undergoing moderate to high risk surgery who become hemodynamic instable during anesthesia in the operating theatre.
When hemodynamic instability under anesthesia occurs focused TTE is conducted and the obtained diagnostic information are used for further patient management. Any change in management or therapy will be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intraoperative TTE | Experimental | Other: intraoperative TTETTE if a hemodynamic instability occurs |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- gender: male, female
- Age ≥ 18 years
- increased perioperative risk, at least one of the following:
- Procedure with at least moderate increased risk
- Hemodynamic instability, at least one of the following:
Key exclusion criteria (1 listed)
- cardiac surgery
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 |
|---|---|---|
| intraoperative TTEAlso: focused transthoracic echocardiography, focused TTE, intraoperative transthoracic echocardiography | Other | intraoperative TTE |
Primary outcome
Change of patients´ management
Time frame: at time of anesthesia / surgery
Recordings of TTE findings influencing change of patient´s management in the operating theatre
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 17 Apr 2014.
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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.
Thomas Kratz, MD principal investigator
Department of Anesthesia and Intensive Care Medicine, University Hospital Marburg, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intraoperative TTE in people with Hemodynamic Instability During Anesthesia and High Risk Surgery, run by Philipps University Marburg 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 19 inclusion and 1 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 17 Apr 2014. 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?
Change of patients´ management (time frame: at time of anesthesia / surgery). 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 17 Apr 2014.