Hypotension on InductionLVOT-VTI-hypotNCT07121699
The Role of Left Ventricular Outflow Tract (LVOT) Velocity-time Integral (VTI) and Respiratory Variability at Peak Rate (Vpeak) in Predicting Hypotension After General Anesthesia Induction
An observational study of Hypotension on Induction, run by Aydin Adnan Menderes University.
Trial summary
Preoperatively, patients will undergo transthoracic echocardiography measurements approximately 15-30 minutes before induction. TTE will be performed on all patients by an experienced observer; the echocardiography device will be equipped with an S4-2 transducer (4-2 MHz frequency range) in the left lateral decubitus… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypotension on Induction
- What is being tested?
- Inotrope
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 20 Aug 2025to 1 Sep 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This study will be conducted on hemodynamically stable patients aged between 18 and 75 years, with an American Society of Anesthesiologists (ASA) physical status classification of I-III, who are scheduled for elective surgery and will undergo general anesthesia.
Who may be able to join
- 18-75 years
- ASA Physical Status 1-3;
- Patients scheduled for general anesthesia
Who cannot join
- Patient is pregnant
- Post-cardiac surgery
- Severe pulmonary hypertension
- Severe valvular disease
- Hypertrophic or dilated cardiomyopathy
- Presence of acute myocardial infarction
Show all 10Show fewer
- Patients with severe visual or hearing impairment/impairment
- ASA physical status IV or V
- Ischemic heart disease, conduction disturbance
- History of long-term use of certain medications (β-blockers, angiotensin-converting enzyme inhibitors, analgesics, sedatives, or tricyclic antidepressants)
About this study
Preoperatively, patients will undergo transthoracic echocardiography measurements approximately 15-30 minutes before induction. TTE will be performed on all patients by an experienced observer; the echocardiography device will be equipped with an S4-2 transducer (4-2 MHz frequency range) in the left lateral decubitus position.
VTI and Vpeak values of the LVOT were measured from manually drawn contours using pulsatile wave Doppler technique in the apical five-chamber view. The Doppler beam was aligned with the aortic blood flow, and the signal was captured at an appropriate angle (<20°).
Read more
The maximum (VTImax) and minimum (VTImin) VTI, as well as the maximum (Vpeakmax) and minimum (Vpeakmin) Vpeak values, were determined over three respiratory cycles. ΔVTI was calculated with the following formula:
ΔVTI = [2 × (VTImax - VTImin) / (VTImax + VTImin)] × 100%.
ΔVpeak was calculated with the following formula:
ΔVpeak = [2 × (Vpeakmax - Vpeakmin) / (Vpeakmax + Vpeakmin)] × 100%. These parameters were analyzed to evaluate the hemodynamic status of patients and estimate fluid responsiveness.
Patients with a 30% decrease from baseline in SBP and a decrease in MAP below 60 mmHg in the first 10 minutes after anesthesia induction were considered to have hypotension. Patients were divided into two groups: "with" and "without" hypotension.
Read the detailed description
The study is planned to be conducted for one year after receiving approval from the non-invasive clinical research ethics committee. Documentation of eligibility and consent will be confirmed at the preoperative visit. During this visit, patients will provide demographic and past medical information, including medication use.
Preoperative transthoracic echocardiography measurements will be performed on all patients 15-30 minutes before induction. TTE will be performed by an experienced observer; the echocardiography device is equipped with an S4-2 transducer (4-2 MHz frequency range) in the left lateral decubitus position. LV Ejection Fraction (EF) measurements will be evaluated in the parasternal long-axis view. ΔVTI and ΔVpeak, and LVOT will be recorded.
Patients will be positioned supine, and the Inferior Vena Cava (IVC) will be imaged through the subxiphoid window. The cursor will be placed 1 cm distal to the hepatic vein IVC entry point, and the IVC diameter will be monitored in M-Mode for 30 seconds. The measurement will be taken at the site where the inferior vena cava diameter is measured during inspiration (IVCins) and expiration (IVCexp) while the patient is breathing normally. Inferior Vena Cava Collapse Ratio (IVC-CI) will be calculated using the formula IVC-CI = (IVCexp - IVCins) / IVCexp.
Intraoperative The patient will be administered the clinic's routine anesthesia protocol. Anesthesia will not be interfered with.
Our clinic's routine anesthesia protocol includes: fentanyl 1μg/kg IV, propofol 1.5 to 2.5 mg/kg IV, lidocaine 1 mg/kg IV, and rocuronium 0.6 mg/kg IV. Sevoflurane 2% is initiated after intubation. Perioperative mean blood pressure will be targeted above 65 mmHg. Hypotension below 65 mmHg MAP will be recorded intraoperatively and postoperatively.
The first post-induction measurement will be taken before tracheal intubation. Baseline hemodynamic parameters and non-invasive and/or hemodynamic values will be recorded every two minutes after induction until the surgical incision. Patients will then undergo urinary catheterization and surgical field preparation. MAP below 55 mmHg or prolonged hypotensive episodes (2 minutes or more) will be treated with ephedrine 0.1 mg/kg. Patients with a 30% decrease from baseline in SBP and a MAP below 65 mmHg in the first 10 minutes after anesthesia induction will be considered hypotension. Patients will be divided into two groups: "with" and "without" hypotension.
E-MEASUREMENTS Demographic data to be obtained will include recording height (cm), weight (kg), age (years), gender, (ASA) physical status, and the specific procedure type. Patients will be questioned about tobacco, alcohol, and drug use. They will also be asked about their medical history, including lung disease, kidney disease, diabetes mellitus, neurological disease, chronic pain conditions, previous surgery or stent placement, and medications. Current preoperative laboratory tests and medication list will be recorded.
The amount of intraoperative bleeding, the amount of blood and blood product transfusions, and the duration of surgery will be recorded.
- Conditions
- Hypotension on Induction
- Being tested
- Inotrope
- Keywords
- respiratory variability in peak velocity (Vpeak), left ventricular outflow tract (LVOT) velocity-time integral (VTI), general anesthesia, hypotension
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InotropeDrug
Hypotensive attacks with MAP below 55 mmHg or prolonged duration (2 minutes or more) will be treated with ephedrine 0.1 mg/kg.
| Study group | Role | What they receive |
|---|---|---|
| with hypotension | Patients with a 30% decrease in SBP from baseline and a decrease in MAP below 65 mmHg in the first 10 minutes after anesthesia induction will be considered to have hypotension. Receives: Drug: Inotrope | |
| none hypotension | Patients with a 30% decrease in SBP from baseline and a decrease in MAP below 65 mmHg in the first 10 minutes after anesthesia induction will be considered to have hypotension. |
What is being measured
The primary outcome is the main question the study is designed to answer.
lvot-vtı
The relationship between hypotension following induction of general anesthesia and respiratory variability in left ventricular outflow tract VTI peak velocity (Vpeak variability).
Measured: 1 hour
Secondary outcomes (1)
lv echo
The relationship between hypotension following induction of general anesthesia and left ventricular function parameters measured by transthoracic echocardiography (TTE).
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start20 Aug 2025 (estimated)
- Primary completion20 Aug 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypotension on InductionStudies of the same condition, open and under way.
- More trials run by Aydin Adnan Menderes UniversityThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ferdi gülaştı, Aydin Adnan Menderes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07121699
- Sponsor's protocol ID
- 2025-08
- Acronym
- LVOT-VTI-hypot
- Status last verified
- Aug 2025
- First submitted
- 7 Aug 2025
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Left Ventricular Outflow Tract (LVOT) Velocity-time Integral (VTI) and Respiratory Variability at Peak Rate (Vpeak) in Predicting Hypotension After General Anesthesia Induction
- ClinicalTrials.gov ID
- NCT07121699
- Acronym / sponsor ID
- LVOT-VTI-hypot / 2025-08
- Conditions
- Hypotension on Induction
- Keywords
- respiratory variability in peak velocity (Vpeak), left ventricular outflow tract (LVOT) velocity-time integral (VTI), general anesthesia, hypotension
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 20 Aug 2025 (estimated)
- Primary completion
- 20 Aug 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 13 Aug 2025 (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.
Preoperatively, patients will undergo transthoracic echocardiography measurements approximately 15-30 minutes before induction. TTE will be performed on all patients by an experienced observer; the echocardiography device will be equipped with an S4-2 transducer (4-2 MHz frequency range) in the left lateral decubitus position.
VTI and Vpeak values of the LVOT were measured from manually drawn contours using pulsatile wave Doppler technique in the apical five-chamber view. The Doppler beam was aligned with the aortic blood flow, and the signal was captured at an appropriate angle (<20°).
The maximum (VTImax) and minimum (VTImin) VTI, as well as the maximum (Vpeakmax) and minimum (Vpeakmin) Vpeak values, were determined over three respiratory cycles. ΔVTI was calculated with the following formula:
ΔVTI = [2 × (VTImax - VTImin) / (VTImax + VTImin)] × 100%.
ΔVpeak was calculated with the following formula:
ΔVpeak = [2 × (Vpeakmax - Vpeakmin) / (Vpeakmax + Vpeakmin)] × 100%. These parameters were analyzed to evaluate the hemodynamic status of patients and estimate fluid responsiveness.
Patients with a 30% decrease from baseline in SBP and a decrease in MAP below 60 mmHg in the first 10 minutes after anesthesia induction were considered to have hypotension. Patients were divided into two groups: "with" and "without" hypotension.
Detailed description
The study is planned to be conducted for one year after receiving approval from the non-invasive clinical research ethics committee. Documentation of eligibility and consent will be confirmed at the preoperative visit. During this visit, patients will provide demographic and past medical information, including medication use.
Preoperative transthoracic echocardiography measurements will be performed on all patients 15-30 minutes before induction. TTE will be performed by an experienced observer; the echocardiography device is equipped with an S4-2 transducer (4-2 MHz frequency range) in the left lateral decubitus position. LV Ejection Fraction (EF) measurements will be evaluated in the parasternal long-axis view. ΔVTI and ΔVpeak, and LVOT will be recorded.
Patients will be positioned supine, and the Inferior Vena Cava (IVC) will be imaged through the subxiphoid window. The cursor will be placed 1 cm distal to the hepatic vein IVC entry point, and the IVC diameter will be monitored in M-Mode for 30 seconds. The measurement will be taken at the site where the inferior vena cava diameter is measured during inspiration (IVCins) and expiration (IVCexp) while the patient is breathing normally. Inferior Vena Cava Collapse Ratio (IVC-CI) will be calculated using the formula IVC-CI = (IVCexp - IVCins) / IVCexp.
Intraoperative The patient will be administered the clinic's routine anesthesia protocol. Anesthesia will not be interfered with.
Our clinic's routine anesthesia protocol includes: fentanyl 1μg/kg IV, propofol 1.5 to 2.5 mg/kg IV, lidocaine 1 mg/kg IV, and rocuronium 0.6 mg/kg IV. Sevoflurane 2% is initiated after intubation. Perioperative mean blood pressure will be targeted above 65 mmHg. Hypotension below 65 mmHg MAP will be recorded intraoperatively and postoperatively.
The first post-induction measurement will be taken before tracheal intubation. Baseline hemodynamic parameters and non-invasive and/or hemodynamic values will be recorded every two minutes after induction until the surgical incision. Patients will then undergo urinary catheterization and surgical field preparation. MAP below 55 mmHg or prolonged hypotensive episodes (2 minutes or more) will be treated with ephedrine 0.1 mg/kg. Patients with a 30% decrease from baseline in SBP and a MAP below 65 mmHg in the first 10 minutes after anesthesia induction will be considered hypotension. Patients will be divided into two groups: "with" and "without" hypotension.
E-MEASUREMENTS Demographic data to be obtained will include recording height (cm), weight (kg), age (years), gender, (ASA) physical status, and the specific procedure type. Patients will be questioned about tobacco, alcohol, and drug use. They will also be asked about their medical history, including lung disease, kidney disease, diabetes mellitus, neurological disease, chronic pain conditions, previous surgery or stent placement, and medications. Current preoperative laboratory tests and medication list will be recorded.
The amount of intraoperative bleeding, the amount of blood and blood product transfusions, and the duration of surgery will be recorded.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| with hypotension | – | Drug: InotropePatients with a 30% decrease in SBP from baseline and a decrease in MAP below 65 mmHg in the first 10 minutes after anesthesia induction will be considered to have hypotension. |
| none hypotension | – | –Patients with a 30% decrease in SBP from baseline and a decrease in MAP below 65 mmHg in the first 10 minutes after anesthesia induction will be considered to have hypotension. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study will be conducted on hemodynamically stable patients aged between 18 and 75 years, with an American Society of Anesthesiologists (ASA) physical status classification of I-III, who are scheduled for elective surgery and will undergo general anesthesia.
Key inclusion criteria (3 listed)
- 18-75 years
- ASA Physical Status 1-3;
- Patients scheduled for general anesthesia
Key exclusion criteria (10 listed)
- Patient is pregnant
- Post-cardiac surgery
- Severe pulmonary hypertension
- Severe valvular disease
- Hypertrophic or dilated cardiomyopathy
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 |
|---|---|---|
| InotropeHypotensive attacks with MAP below 55 mmHg or prolonged duration (2 minutes or more) will be treated with ephedrine 0.1 mg/kg. | Drug | with hypotension |
Primary outcome
lvot-vtı
Time frame: 1 hour
The relationship between hypotension following induction of general anesthesia and respiratory variability in left ventricular outflow tract VTI peak velocity (Vpeak variability).
1 secondary outcome
lv echo
Time frame: 1 hour
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
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Anesthesia
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypotension on Induction, run by Aydin Adnan Menderes University.
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 3 inclusion and 10 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: opening soon, as of the sponsor's last update on 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
lvot-vtı (time frame: 1 hour). 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 13 Aug 2025.