Internal Jugular Vein and Spinal-induced Hypotension

Haemodynamic Instability Clinical Trial

Official title:

Internal Jugular Vein Ultrasound for the Prediction of Spinal-induced Hypotension in Elderly Patients With Orthopaedic Trauma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05015218
• Other study ID #: ID: 33320178-Attikon Hospital
• Status: Recruiting
• Start date: November 1, 2021
• Est. completion date: January 2, 2025

Study information

• Verified date: June 2024
• Source: Attikon Hospital
• Contact: NEFELI MOSCHOVAKI, PROFESSOR
• Phone: 6978400709
• Email: nefelimos91[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. Therefore, it is evaluated the diagnostic performance of these indices in predicting spinal-induced hypotension in this subset of participants.

Description:

1. Study design. The present, observational, prospective study, will be conducted over a 12-month period,

2. Population. Consecutive sampling is used to recruit aging patients (>70 years), who sustain trauma of the lower limb and underwent an orthopedic surgical procedure under spinal anesthesia.

More specifically, patients included, are subjected to an orthopaedic surgical repair of a proximal femur fracture under spinal anaesthesia. Patients' medical history, 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.

All patients in our study are American College of Cardiology (ACC) stage I OR II, and their cardiac disease status is compensated. As per departmental protocol and fasting guidelines, all patients could receive clear liquids and solid food until 2 and 8 hours before surgery, respectively. Creatinine and urea values and subsequently GFR are measured in all patients.

Exclusion criteria includes moderate or severe pulmonary hypertension, tachycardia (heart rate > 100 beats/min), atrial fibrillation with heart rate> 100 beats/min. 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

3. 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 diameter)/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.

4. 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 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 nurse not further involved in the study.

5. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 2, 2025
• Est. primary completion date: December 1, 2024
• Gender: All
• Age group: 70 Years and older

Eligibility

Inclusion Criteria:

1. Elderly patients with orthopaedic trauma of the lower limb,

2. American Heart Association/American College of Cardiology (ACC) stage I or II.

3. Cardiac disease is in a compensated status.

Exclusion Criteria:

1. Atria fibrilation/Tachycardia (heart rate > 100 beats/min)

2. Sensory block less than T12

3. Overt bleeding

4. Severe/moderate pulmonary hypertensopn

Related Conditions & MeSH terms

• Haemodynamic Instability
• Hypotension

Intervention

Diagnostic Test:
• Vacular Ultrasound
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 at the end of inspiration (IJVmin), the IJV collapsibility index (IJV-CI) during spontaneous, quiet, breathing, [(IJVmax - IJVmin diameter)/IJVmax] and the ratio (R) of IJVmax-to-IJV-CI.

Locations

Country	Name	City	State
Greece	Department of anesthesia ,ATTIKON UNIVERSITY HOSPITAL OF ATHENS	Athens	Attica
Greece	Theodosios Saranteas	Athens	Gerakas

Sponsors (2)

Lead Sponsor	Collaborator
Attikon Hospital	Ohio State University

Country where clinical trial is conducted

Greece, 

References & Publications (1)

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 C — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	10 minutes prior to spinal anesthesia