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Haemodynamic InstabilityNCT05015218

Internal Jugular Vein and Spinal-induced Hypotension

An observational study of Haemodynamic Instability, run by Attikon Hospital at 2 sites in Greece.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in Greece

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

  1. 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.
  2. 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.

  1. 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.
  2. 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.

  1. Follow up: Assessing hypotension due to spinal-anesthesia intraoperatively.
  2. 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.
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.

  1. 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.

  1. First posted20 Aug 2021
  2. Study start23 Nov 2021
  3. Primary completion27 Oct 2024
  4. Study completion27 Oct 2024

Resources

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
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

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.

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