Haemodynamic InstabilityNCT05015218
Internal Jugular Vein and Spinal-induced Hypotension
An observational study of Haemodynamic Instability, run by Attikon Hospital at 2 sites in Greece.
Trial summary
The study aims to assess internal jugular vein ultrasound derived measurements and indices prior to spinal anesthesia in elderly population who fulfills predetermined inclusion criteria and might greatly benefit from an appropriate hemodynamic control during orthopedic surgery. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Haemodynamic Instability
- What is being tested?
- Vacular Ultrasound
- How many people
- 50 participants
- Where
- 2 sitesGreece
- Study dates
- 23 Nov 2021to 27 Oct 2024
- How long will I take part?
- 1 Day
- 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 70 years and older
- All sexes
- Older adult
Study population: Consecutive sampling is used to recruit dehydrated aging patients (>70 years), who sustain trauma of the lower limb and underwent an orthopedic surgical procedure under spinal anesthesia. Patients' medical history, blood tests, physical examination, ECG, and X-ray assessment are standard practice, supplemented by specific exams or tests (e.g. TTE or pro-BNP levels), were performed per the consultant cardiologist's recommendations. All patients in our study were American Heart Association/American College of Cardiology (ACC) stage I, II and their cardiac disease is in a compensated status;
Who may be able to join
- Dehydrated elderly patients with orthopaedic trauma of the lower limb,
- American Heart Association/American College of Cardiology (ACC) stage I or II.
- Cardiac disease is in a compensated status.
Who cannot join
- Atria fibrilation/Tachycardia (heart rate > 100 beats/min)
- Sensory block less than T12
- Overt intraoperative bleeding
- Severe pulmonary hypertensopn/tricuspid regurgitation
Trial locations and contacts
2 sites in 1 country.
Greece2 sites
Department of anesthesia ,ATTIKON UNIVERSITY HOSPITAL OF ATHENS
Athens, Attica, 15562
Theodosios Saranteas
Athens, Gerakas, 15344
About this study
Official title: Internal Jugular Vein Ultrasound for the Prediction of Spinal-induced Hypotension in Dehydrated Elderly Patients With Orthopaedic Trauma
The study aims to assess internal jugular vein ultrasound derived measurements and indices prior to spinal anesthesia in elderly population who fulfills predetermined inclusion criteria and might greatly benefit from an appropriate hemodynamic control during orthopedic surgery. Therefore, it is evaluated the diagnostic performance of these indices in predicting spinal-induced hypotension in this subset of participants.
Read the detailed description
Study design; Observational
- Recruitment: Preoperative anesthetic and cardiovascular evaluation by the anesthesiology department as well as the cardiology department to define patients with predetermined criteria. Patients' medical history, blood tests (e.g. blood urea and cratinine) physical examination, electrocardiogram (ECG), and X-ray assessment are performed during the pre-operative assessment, supplemented by specific exams or tests (e.g. TTE, troponin or pro-BNP levels) as per the consultant cardiologists' recommendations. Consecutive sampling of aging patients (>70 years), who sustain trauma of the lower limb(hip fractures) undergoing an orthopedic surgical procedure (hip fracture repair) and planned spinal anesthesia. More specifically, patients included, are subjected to an orthopaedic surgical repair of a proximal femur fracture under spinal anaesthesia. All patients or their relatives provide a written consent to participate in the study.
- Inclusion criteria/initial screening: Age>70 years. Nitrogen Urea/Creatinine>20.American College of Cardiology (ACC) stage I or II.
Exclusion criteria includes severe pulmonary hypertension/tricuspid regurgitation, tachycardia (heart rate \> 100 beats/min), atrial fibrillation. Additionally, all patients who has spinal anaesthesia and the maximum cephalad dermatomal extension of the sensory block is below T12 are excluded from the study. Arterial hypotension related to overt intra-operative bleeding (\>150 cc) or patients requiring blood transfusion, for any reason, is not considered in the statistical analysis.
- Preoperative POCUS IJV ultrasonography To visualize both the right and left IJV a linear transducer with a 5-10 MHz linear probe is placed over the neck, and the IJV is measured just below the bifurcation of the sternal and clavicular heads of the muscle. The IJV measurements are performed on the transverse axis during spontaneous quiet, breathing. Patients with evidence of IJV thrombosis are excluded. IJV measurements included the maximum area at the end of expiration (IJVmax), the minimum area at the end of inspiration (IJVmin), the IJV collapsibility index (IJV-CI): [(IJVmax - IJVmin area)/IJVmax] and the ratio (R) of IJVmax-to-IJV-CI. Two examiners each performed all the measurements, generating two values; the mean of these values is used for analysis.
- Anesthetic protocol and measurements. Spinal anesthesia is introduced with a single intrathecal injection of 0.75% (15 mg) plain ropivacaine using a 22 or 25-gauge needle with the patient in the lateral or sitting position. Intraoperative ECG, SPO2 and non-invasive blood pressure (measurements every two minutes) monitoring are routinely used. The non-invasive blood pressure is measured every 2 minutes and vital parameters are recorded continuously throughout surgery.
Patients experiencing a MAP (two consecutive measurements) less than or equal to 65 mmHg, or greater than or equal to 25% reduction of its baseline preoperative value is considered hypotensive Arterial hypotension related to bone cement application, intraoperative/postoperative bleeding with blood loss greater than 150cc or patients receiving blood transfusion for any reason are not considered in our statistical analysis.
The degree of sensory block (cold test) is assessed by an anesthesia staff not further involved in the study.
- Follow up: Assessing hypotension due to spinal-anesthesia intraoperatively.
- Statistical analysis Sample size: Previously, many echocardiographic indices have been used to predict spinal-induced hypotension. The collapsibility index of the inferior vena cava has showed an area under the curve in a receiver operating characteristic curve analysis between 0.77. We hypothesized, therefore, that the area under the curve of the IJV-CI would be at least 0.77 to predict spinal induced hypotension. We calculated the required sample size for the comparison of the area under a receiver operating characteristic curve with a null hypothesis value. Considering the α error of 0.05 with 90% power, 42 patients are needed. To allow for a possible 20% dropout rate, at least a sample size of 50 patients.
- Conditions
- Haemodynamic Instability
- Being tested
- Vacular Ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vacular UltrasoundDiagnostic test
Also called Blood pressure recordings
To visualize the internal jugular veins ( IJVs) a linear transducer with a 5-10 MHz linear probe was placed over the neck, and the IJV was measured just below the bifurcation of the sternal and clavicular heads of the muscle. The IJV measurements were performed on the transverse axis over a single respiratory cycle. Patients with evidence of IJV thrombosis were excluded. IJV measurements included the antero-posterior maximum diameter at the end of expiration (IJVmax), the antero-posterior mimimum diameter/area at the end of inspiration (IJVmin), the IJV collapsibility index (IJV-CI) during spontaneous, quiet, breathing, [(IJVmax - IJVmin area)/IJVmax] and the ratio (R) of IJVmax-to-IJV-CI.
What is being measured
The primary outcome is the main question the study is designed to answer.
Internal jugular vein aerea (cm2) prior to spinal anesthesia implementation
Using GE-T8 Ultrasound System device, the right and leftinternal jugular vein is visualized on the short axis with a 5-10 MHz linear probe in B-mode.
Measured: 10 minutes prior to spinal anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2021
- Study start23 Nov 2021
- Primary completion27 Oct 2024
- Study completion27 Oct 2024
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 Haemodynamic 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Attikon Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ohio State University
- Responsible party
- Principal investigator, THEODOSIOS SARANTEAS, Attikon Hospital
- Investigators
- HEODOSIOS SARANTEAS, PROFESSOR, Principal investigator, MEDICAL SCHOOL UNIVERSITY OF ATHENS, NKUA, GREECE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05015218
- Sponsor's protocol ID
- ID: EBΔ 630 (23/11/2021)
- Status last verified
- Feb 2025
- First submitted
- 9 Aug 2021
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Saranteas T, Spiliotaki H, Koliantzaki I, Koutsomanolis D, Kopanaki E, Papadimos T, Kostopanagiotou G. The Utility of Echocardiography for the Prediction of Spinal-Induced Hypotension in Elderly Patients: Inferior Vena Cava Assessment Is a Key Player. J Cardiothorac Vasc Anesth. 2019 Sep;33(9):2421-2427. doi: 10.1053/j.jvca.2019.02.032. Epub 2019 Feb 22.
PubMed 30904260
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internal Jugular Vein Ultrasound for the Prediction of Spinal-induced Hypotension in Dehydrated Elderly Patients With Orthopaedic Trauma
- ClinicalTrials.gov ID
- NCT05015218
- Acronym / sponsor ID
- ID: EBΔ 630 (23/11/2021)
- Conditions
- Haemodynamic Instability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Attikon HospitalUniversity, hospital or other
- Collaborators
- Ohio State University
- Study start
- 23 Nov 2021 (actual)
- Primary completion
- 27 Oct 2024 (actual)
- Study completion
- 27 Oct 2024 (actual)
- First posted
- 20 Aug 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.
The study aims to assess internal jugular vein ultrasound derived measurements and indices prior to spinal anesthesia in elderly population who fulfills predetermined inclusion criteria and might greatly benefit from an appropriate hemodynamic control during orthopedic surgery. Therefore, it is evaluated the diagnostic performance of these indices in predicting spinal-induced hypotension in this subset of participants.
Detailed description
Study design; Observational
- Recruitment: Preoperative anesthetic and cardiovascular evaluation by the anesthesiology department as well as the cardiology department to define patients with predetermined criteria. Patients' medical history, blood tests (e.g. blood urea and cratinine) physical examination, electrocardiogram (ECG), and X-ray assessment are performed during the pre-operative assessment, supplemented by specific exams or tests (e.g. TTE, troponin or pro-BNP levels) as per the consultant cardiologists' recommendations. Consecutive sampling of aging patients (>70 years), who sustain trauma of the lower limb(hip fractures) undergoing an orthopedic surgical procedure (hip fracture repair) and planned spinal anesthesia. More specifically, patients included, are subjected to an orthopaedic surgical repair of a proximal femur fracture under spinal anaesthesia. All patients or their relatives provide a written consent to participate in the study.
- Inclusion criteria/initial screening: Age>70 years. Nitrogen Urea/Creatinine>20.American College of Cardiology (ACC) stage I or II.
Exclusion criteria includes severe pulmonary hypertension/tricuspid regurgitation, tachycardia (heart rate \> 100 beats/min), atrial fibrillation. Additionally, all patients who has spinal anaesthesia and the maximum cephalad dermatomal extension of the sensory block is below T12 are excluded from the study. Arterial hypotension related to overt intra-operative bleeding (\>150 cc) or patients requiring blood transfusion, for any reason, is not considered in the statistical analysis.
- Preoperative POCUS IJV ultrasonography To visualize both the right and left IJV a linear transducer with a 5-10 MHz linear probe is placed over the neck, and the IJV is measured just below the bifurcation of the sternal and clavicular heads of the muscle. The IJV measurements are performed on the transverse axis during spontaneous quiet, breathing. Patients with evidence of IJV thrombosis are excluded. IJV measurements included the maximum area at the end of expiration (IJVmax), the minimum area at the end of inspiration (IJVmin), the IJV collapsibility index (IJV-CI): [(IJVmax - IJVmin area)/IJVmax] and the ratio (R) of IJVmax-to-IJV-CI. Two examiners each performed all the measurements, generating two values; the mean of these values is used for analysis.
- Anesthetic protocol and measurements. Spinal anesthesia is introduced with a single intrathecal injection of 0.75% (15 mg) plain ropivacaine using a 22 or 25-gauge needle with the patient in the lateral or sitting position. Intraoperative ECG, SPO2 and non-invasive blood pressure (measurements every two minutes) monitoring are routinely used. The non-invasive blood pressure is measured every 2 minutes and vital parameters are recorded continuously throughout surgery.
Patients experiencing a MAP (two consecutive measurements) less than or equal to 65 mmHg, or greater than or equal to 25% reduction of its baseline preoperative value is considered hypotensive Arterial hypotension related to bone cement application, intraoperative/postoperative bleeding with blood loss greater than 150cc or patients receiving blood transfusion for any reason are not considered in our statistical analysis.
The degree of sensory block (cold test) is assessed by an anesthesia staff not further involved in the study.
- Follow up: Assessing hypotension due to spinal-anesthesia intraoperatively.
- Statistical analysis Sample size: Previously, many echocardiographic indices have been used to predict spinal-induced hypotension. The collapsibility index of the inferior vena cava has showed an area under the curve in a receiver operating characteristic curve analysis between 0.77. We hypothesized, therefore, that the area under the curve of the IJV-CI would be at least 0.77 to predict spinal induced hypotension. We calculated the required sample size for the comparison of the area under a receiver operating characteristic curve with a null hypothesis value. Considering the α error of 0.05 with 90% power, 42 patients are needed. To allow for a possible 20% dropout rate, at least a sample size of 50 patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Age groups
- Older adult
- Study population
- Consecutive sampling is used to recruit dehydrated aging patients (>70 years), who sustain trauma of the lower limb and underwent an orthopedic surgical procedure under spinal anesthesia. Patients' medical history, blood tests, physical examination, ECG, and X-ray assessment are standard practice, supplemented by specific exams or tests (e.g. TTE or pro-BNP levels), were performed per the consultant cardiologist's recommendations. All patients in our study were American Heart Association/American College of Cardiology (ACC) stage I, II and their cardiac disease is in a compensated status;
Key inclusion criteria (3 listed)
- Dehydrated elderly patients with orthopaedic trauma of the lower limb,
- American Heart Association/American College of Cardiology (ACC) stage I or II.
- Cardiac disease is in a compensated status.
Key exclusion criteria (4 listed)
- Atria fibrilation/Tachycardia (heart rate > 100 beats/min)
- Sensory block less than T12
- Overt intraoperative bleeding
- Severe pulmonary hypertensopn/tricuspid regurgitation
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 |
|---|---|---|
| Vacular UltrasoundAlso: Blood pressure recordingsTo visualize the internal jugular veins ( IJVs) a linear transducer with a 5-10 MHz linear probe was placed over the neck, and the IJV was measured just below the bifurcation of the sternal and clavicular heads of the muscle. The IJV measurements were performed on the transverse axis over a single respiratory cycle. Patients with evidence of IJV thrombosis were excluded. IJV measurements included the antero-posterior maximum diameter at the end of expiration (IJVmax), the antero-posterior mimimum diameter/area at the end of inspiration (IJVmin), the IJV collapsibility index (IJV-CI) during spontaneous, quiet, breathing, [(IJVmax - IJVmin area)/IJVmax] and the ratio (R) of IJVmax-to-IJV-CI. | Diagnostic test | – |
Primary outcome
Internal jugular vein aerea (cm2) prior to spinal anesthesia implementation
Time frame: 10 minutes prior to spinal anesthesia
Using GE-T8 Ultrasound System device, the right and leftinternal jugular vein is visualized on the short axis with a 5-10 MHz linear probe in B-mode.
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 25 Feb 2025.
- Results publication: PubMed 30904260Saranteas T, Spiliotaki H, Koliantzaki I, Koutsomanolis D, Kopanaki E, Papadimos T, Kostopanagiotou G. The Utility of Echocardiography for the Prediction of Spinal-Induced Hypotension in Elderly Patients: Inferior Vena Cava Assessment Is a Key Player. J Cardiothorac Vasc Anesth. 2019 Sep;33(9):2421-2427. doi: 10.1053/j.jvca.2019.02.032. Epub 2019 Feb 22.
- 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.
HEODOSIOS SARANTEAS, PROFESSOR principal investigator
MEDICAL SCHOOL UNIVERSITY OF ATHENS, NKUA, GREECE
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Haemodynamic Instability, run by Attikon Hospital at 2 sites in Greece.
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 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 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Greece. 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?
Internal jugular vein aerea (cm2) prior to spinal anesthesia implementation (time frame: 10 minutes prior to spinal anesthesia). 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 NCT05015218, 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 25 Feb 2025.