Stellate Ganglion Neuromodulation for the Treatment of Electrical Storm

MI-összefoglaló

A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.

The trial is looking for adults in intensive care with a VT storm, which means repeated dangerous fast heart rhythms. It tests a nerve block in the neck against a sham procedure.

Életkor

18 years or older

Nem

All sexes can join

A betegség stádiuma

3 or more VT/VF episodes within 24 hours, counting episodes stopped by a device shock or pacing. The last episode was less than 12 hr ago.

Korábbi kezelés

People who had a heart transplant or cardiac sympathetic denervation (CSD), a surgery on the heart nerves, cannot join.

A részvétel fő kizáró okai

• Reasons a nerve block cannot be done, such as infection at the site, allergy to the drug, or a neck mass or neck cancer
• VT storm caused by an inherited heart rhythm condition (LQTS, SQTS, Brugada, CPVT or CRDS)
• Platelet count below 50,000 /µL
• VT/VF during an acute heart attack before blood flow is restored, or VT storm from a reversible cause such as metabolic or drug-related
• Consent cannot be obtained from the patient or a substitute decision maker

A regiszter feltételei, szó szerint

Mit akar kideríteni a vizsgálat

Ventricular tachycardia (VT) is a serious heart rhythm problem in which the heart beats very fast and in an abnormal way. These abnormal heart rhythms can be life-threatening. When a person has three or more episodes of VT within a 24-hour period, it is called a "VT storm." VT storm can be difficult to treat because some patients do not respond well to standard medications. Some studies suggest that a procedure called a stellate ganglion block (SGB) may help. An SGB involves injecting a local anesthetic near a group of nerves in the neck that help control signals between the brain and the heart. The procedure can be performed at the bedside using ultrasound guidance.

A vizsgálat 2 csoportja

• Stellate Ganglion Block ArmA vizsgált kezelés

  SGB will be performed according to local practice. Local anesthesia will be delivered subcutaneously prior to the procedure. SGB should typically occurs under dynamic ultrasound guidance. Once a landmark for the SGB is identified (e.g., the C6 anterior tubercle), 10 mL of 0.5% bupivacaine will be injected into the left side of the neck using a 22-25G nerve block spinal needle ventral to the longus colli muscle and beneath the prevertebral fascia. This will be a one-time injection. The efficacy of the block will be assessed qualitatively by the operator at the time of the procedure. Any unused bupivacaine will be discarded. The procedure typically takes approximately 20 minutes.

  Kezelés: Stellate Ganglion Block Injection with Bupivicaine

• Sham Procedure ArmSzínlelt kezelés, összehasonlításként

  The sham-procedure will use the identical preparatory and procedure steps as described for the active arm. The duration of the sham procedure will match that of the active intervention, and communication during the procedure will be standardized for both arms. Once the skin is draped and cleaned, control arm participants will have 1 mL of 0.5% bupivacaine injected, subcutaneously only. The operator will discard the unused bupivacaine to maintain blinding.

  Kezelés: Sham procedure control