Anesthesia(Tapse)NCT04580030
Tricuapid Annular Plane Sistolic Excursion Before General Anesthesia Can Predict Hypotension After Induction
An observational study of Anesthesia, run by Bursa City Hospital at 1 site in Turkey (Türkiye).
Trial summary
the investigators purpose is to predict hypotensive condition that can develop after general anesthesia induction by measuring the Tricuspid Annular Plane Systolic Movement (TAPSE), which is an echocardiographic parameter. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anesthesia
- How many people
- 7 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Sep 2020to 10 Sep 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: It was planned that a total of 40 patients undergoing elective general surgery under general anesthesia with standard general anesthesia induction would be included in this prospective and observational study.
Who may be able to join
- Patients scheduled for elective surgery
- Patients who will receive general anesthesia
- Patients between 18-65 years of age
- Physical status I or II according to the American Society of Anesthetists (ASA) in preoperative evaluation
- Those without known heart disease
- Patients with TAPSE value above 1.6 cm
Who cannot join
- Patients under the age of 8 and over 65,
- Pregnant patients,
- Patients who refuse to participate in the study,
- ASA III and above,
- Patients with known heart disease,
- Patients with TAPSE value of less than 1.6 measured with Transthoracic Echocardiography will not be allowed to be included in the study.
- Patients with difficult airway management or difficult intubation will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
the investigators purpose is to predict hypotensive condition that can develop after general anesthesia induction by measuring the Tricuspid Annular Plane Systolic Movement (TAPSE), which is an echocardiographic parameter.
Read the detailed description
Intraoperative hypotension development might increase myocardial damage, acute kidney damage, and septic complications, and have an effect on mortality increase. For this reason, prevention of an unwanted hypotensive event has an important role in reducing mortality and morbidity. The prediction of the risk of hypotension is generally based on the evaluation of the comorbid status and volume status of patients .It is already known that right ventricular systolic dysfunction has prognostic value in various pathological cases. It is quite difficult to evaluate the RV function with echocardiography because of the complex geometry of RV. Although RV function has been evaluated only visually for many years, guidelines have been published as a result of recent studies by the American Society of Echocardiography. In this respect, abnormal RV function should be suspected when one of the criteria of S '<10 cm /s, TAPSE <16 mm, RVFAC <35%, or R-MPI (Tissue Doppler)> 0.55. Normal and abnormal function is distinguished more reliably when combining more than one RV function measures. TAPSE is a parameter with which the apex-basal shortening can be easily measured, providing specific data on global RV function. It depends less on optimal image quality than other RV function measurements, and is an easy-to-measure criterion. Low TAPSE is not very common; however, it was measured in people with no heart disease due to diagnostic misclassification and excessive ends of the normal spectrum. the investigators think that despite the lack of cardiac disease, cardiac reserve functions of each patient may have limits in terms of development of hypotension in general anesthesia induction. The investigators considered that TAPSE, which decreased within normal limits in patients without cardiac disease, could predict hypotension development in general anesthesia induction, and planned study for this purpose.
- Conditions
- Anesthesia
- Keywords
- General anesthesia, tricuspid anular plane systolic excursion, hypotension
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| hypotension | Basal hemodynamic parameters and hemodynamic values will be taken every two minutes after induction until surgical incision. Patients with systolic pressure <90 mmHg or 30% drop in baseline, and mean artery pressure below 60 mmHg will be considered to have hypotension. Patients will be divided into two groups as "Hypotension" and "No Hypotension". | |
| no hypotension | Basal hemodynamic parameters and hemodynamic values will be taken every two minutes after induction until surgical incision. Patients with systolic pressure <90 mmHg or 30% drop in baseline, and mean artery pressure below 60 mmHg will be considered to have hypotension. Patients will be divided into two groups as "Hypotension" and "No Hypotension". |
What is being measured
The primary outcome is the main question the study is designed to answer.
tricuspid anular plane systolic excursion(TAPSE)
The investigators purpose is to predict hypotensive condition that can develop after general anesthesia induction by measuring the Tricuspid Annular Plane Systolic Movement (TAPSE), which is an echocardiographic parameter.
Measured: TAPSE will be measured with Transthoracic Echocardiography about 30 minutes before the induction in the preoperative period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start9 Sep 2020
- Primary completion9 Sep 2021 (estimated)
- Study completion10 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bursa City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ferdi GÜLAŞTI, Bursa City Hospital
- Investigators
- Ferdi Gülaştı, Study chair, Bursa City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04580030
- Sponsor's protocol ID
- 2020-6/1
- Acronym
- (Tapse)
- Status last verified
- Oct 2020
- First submitted
- 2 Oct 2020
- Last updated
- 20 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Zhang J, Critchley LA. Inferior Vena Cava Ultrasonography before General Anesthesia Can Predict Hypotension after Induction. Anesthesiology. 2016 Mar;124(3):580-9. doi: 10.1097/ALN.0000000000001002.
PubMed 26771910Szabo M, Bozo A, Darvas K, Horvath A, Ivanyi ZD. Role of inferior vena cava collapsibility index in the prediction of hypotension associated with general anesthesia: an observational study. BMC Anesthesiol. 2019 Aug 7;19(1):139. doi: 10.1186/s12871-019-0809-4.
PubMed 31390983Main AB, Braham R, Campbell D, Inglis AJ, McLean A, Orde S. Subcostal TAPSE: a retrospective analysis of a novel right ventricle function assessment method from the subcostal position in patients with sepsis. Ultrasound J. 2019 Aug 27;11(1):19. doi: 10.1186/s13089-019-0134-7.
PubMed 31456096
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tricuapid Annular Plane Sistolic Excursion Before General Anesthesia Can Predict Hypotension After Induction
- ClinicalTrials.gov ID
- NCT04580030
- Acronym / sponsor ID
- (Tapse) / 2020-6/1
- Conditions
- Anesthesia
- Keywords
- General anesthesia, tricuspid anular plane systolic excursion, hypotension
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 7 participants (estimated)
- Lead sponsor
- Bursa City HospitalOther government
- Study start
- 9 Sep 2020 (actual)
- Primary completion
- 9 Sep 2021 (estimated)
- Study completion
- 10 Sep 2021 (estimated)
- First posted
- 8 Oct 2020 (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.
the investigators purpose is to predict hypotensive condition that can develop after general anesthesia induction by measuring the Tricuspid Annular Plane Systolic Movement (TAPSE), which is an echocardiographic parameter.
Detailed description
Intraoperative hypotension development might increase myocardial damage, acute kidney damage, and septic complications, and have an effect on mortality increase. For this reason, prevention of an unwanted hypotensive event has an important role in reducing mortality and morbidity. The prediction of the risk of hypotension is generally based on the evaluation of the comorbid status and volume status of patients .It is already known that right ventricular systolic dysfunction has prognostic value in various pathological cases. It is quite difficult to evaluate the RV function with echocardiography because of the complex geometry of RV. Although RV function has been evaluated only visually for many years, guidelines have been published as a result of recent studies by the American Society of Echocardiography. In this respect, abnormal RV function should be suspected when one of the criteria of S '<10 cm /s, TAPSE <16 mm, RVFAC <35%, or R-MPI (Tissue Doppler)> 0.55. Normal and abnormal function is distinguished more reliably when combining more than one RV function measures. TAPSE is a parameter with which the apex-basal shortening can be easily measured, providing specific data on global RV function. It depends less on optimal image quality than other RV function measurements, and is an easy-to-measure criterion. Low TAPSE is not very common; however, it was measured in people with no heart disease due to diagnostic misclassification and excessive ends of the normal spectrum. the investigators think that despite the lack of cardiac disease, cardiac reserve functions of each patient may have limits in terms of development of hypotension in general anesthesia induction. The investigators considered that TAPSE, which decreased within normal limits in patients without cardiac disease, could predict hypotension development in general anesthesia induction, and planned study for this purpose.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hypotension | – | –Basal hemodynamic parameters and hemodynamic values will be taken every two minutes after induction until surgical incision. Patients with systolic pressure <90 mmHg or 30% drop in baseline, and mean artery pressure below 60 mmHg will be considered to have hypotension. Patients will be divided into two groups as "Hypotension" and "No Hypotension". |
| no hypotension | – | –Basal hemodynamic parameters and hemodynamic values will be taken every two minutes after induction until surgical incision. Patients with systolic pressure <90 mmHg or 30% drop in baseline, and mean artery pressure below 60 mmHg will be considered to have hypotension. Patients will be divided into two groups as "Hypotension" and "No Hypotension". |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- It was planned that a total of 40 patients undergoing elective general surgery under general anesthesia with standard general anesthesia induction would be included in this prospective and observational study.
Key inclusion criteria (6 listed)
- Patients scheduled for elective surgery
- Patients who will receive general anesthesia
- Patients between 18-65 years of age
- Physical status I or II according to the American Society of Anesthetists (ASA) in preoperative evaluation
- Those without known heart disease
Key exclusion criteria (7 listed)
- Patients under the age of 8 and over 65,
- Pregnant patients,
- Patients who refuse to participate in the study,
- ASA III and above,
- Patients with known heart disease,
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
tricuspid anular plane systolic excursion(TAPSE)
Time frame: TAPSE will be measured with Transthoracic Echocardiography about 30 minutes before the induction in the preoperative period.
The investigators purpose is to predict hypotensive condition that can develop after general anesthesia induction by measuring the Tricuspid Annular Plane Systolic Movement (TAPSE), which is an echocardiographic parameter.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2020.
- Background: PubMed 26771910Zhang J, Critchley LA. Inferior Vena Cava Ultrasonography before General Anesthesia Can Predict Hypotension after Induction. Anesthesiology. 2016 Mar;124(3):580-9. doi: 10.1097/ALN.0000000000001002.
- Results publication: PubMed 31390983Szabo M, Bozo A, Darvas K, Horvath A, Ivanyi ZD. Role of inferior vena cava collapsibility index in the prediction of hypotension associated with general anesthesia: an observational study. BMC Anesthesiol. 2019 Aug 7;19(1):139. doi: 10.1186/s12871-019-0809-4.
- Results publication: PubMed 31456096Main AB, Braham R, Campbell D, Inglis AJ, McLean A, Orde S. Subcostal TAPSE: a retrospective analysis of a novel right ventricle function assessment method from the subcostal position in patients with sepsis. Ultrasound J. 2019 Aug 27;11(1):19. doi: 10.1186/s13089-019-0134-7.
- 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.
Ferdi Gülaştı study chair
Bursa City Hospital
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 Anesthesia, run by Bursa City Hospital at 1 site in Turkey (Türkiye).
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 6 inclusion and 7 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 20 Oct 2020. 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 Turkey (Türkiye). 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?
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?
tricuspid anular plane systolic excursion(TAPSE) (time frame: TAPSE will be measured with Transthoracic Echocardiography about 30 minutes before the induction in the preoperative period.). 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 NCT04580030, which also lists 3 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 20 Oct 2020.