Sedation for Stroke

(SEACOAST Trial)

Overseen By Gilda Avila

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Los Angeles

Disqualifiers: Renal failure, Illicit drug use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: Immediate procedure

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines different methods of using general anesthesia (GA) during emergency stroke treatment to determine which method best improves blood flow and recovery. It compares two approaches: one that maintains normal carbon dioxide levels in the blood and another that allows slightly higher levels, focusing on tight control of end-tidal CO2 levels. The trial targets patients with a stroke caused by a blocked large artery in the brain's front part. Those who have recently experienced a stroke and are scheduled for a mechanical procedure to remove the blockage may qualify. Participants must arrive at one of two specific medical centers in Los Angeles for evaluation. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance future stroke treatments.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these methods of general anesthesia are safe for stroke patients?

Research has shown that controlling carbon dioxide (CO2) levels during surgery can influence patient recovery. For instance, one study found that certain CO2 levels are linked to better recovery outcomes. However, another study indicated that the exact effect of CO2 levels on recovery remains unclear.

These clinical trials test two different breathing methods. One method maintains normal CO2 levels (normocarbia), while the other allows for slightly higher levels (mild hypercarbia).

Existing evidence suggests these methods are generally safe. The main difference lies in how CO2 levels are managed during surgery. Although research has not clearly determined which method is best, both approaches involve careful CO2 control to ensure patient safety.

This trial phase aims to determine which method works better, as previous studies have shown these approaches are safe enough for further testing. Participants can expect close monitoring to ensure their safety throughout the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the impact of tightly controlling end-tidal CO2 levels during general anesthesia in stroke patients. Unlike standard treatments that focus primarily on stabilizing the patient's condition and managing symptoms post-stroke, this approach investigates how precise CO2 management might influence brain recovery. By comparing mild hypercarbia (higher CO2 levels) and normocarbia (normal CO2 levels), scientists hope to uncover how different CO2 levels affect brain function and outcomes in stroke patients, potentially leading to more effective sedation practices during critical care.

What evidence suggests that this trial's treatments could be effective for acute ischemic stroke?

Research has shown that managing carbon dioxide (CO2) levels during anesthesia affects blood flow in the brain. This trial will compare two methods: one group will receive general anesthesia with mild hypercarbia (GAH), where slightly higher CO2 levels may increase blood flow to the brain, potentially aiding patients with acute ischemic stroke by delivering more oxygen to affected areas. Another group will receive general anesthesia with normocarbia (GAN), where CO2 levels remain normal to help maintain stable brain function. Both methods aim to improve recovery after a stroke, but the best approach remains under study. ^{6 7 8 9 10}

Who Is on the Research Team?

Radoslav Raychev, MD

Principal Investigator

University of California, Los Angeles

Are You a Good Fit for This Trial?

This trial is for adults over 18 with a specific type of stroke caused by a blockage in the brain's large blood vessels. They must be candidates for a procedure to remove the clot within 24 hours of symptoms starting and have had good health before the stroke. People can't join if they were intubated before evaluation, are likely to die within 3 months, have severe brain damage on scans, or other serious conditions.

Inclusion Criteria

I was independent in daily activities before my current illness.

I am considered for a clot removal procedure within 24 hours of my last normal health state and within 90 minutes of arriving at the emergency department.

My stroke severity score or imaging results meet specific criteria for early treatment.

Exclusion Criteria

You have another illness that could make it hard to measure your brain and body function accurately, or that could affect your ability to finish all the check-up visits.

You have had a condition called malignant hyperthermia in the past.

I need dialysis or cannot have an angiogram due to health reasons.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo mechanical thrombectomy with either general anesthesia with normocarbia or mild hypercarbia

Immediate procedure

1 visit (in-person)

Post-procedure Monitoring

Participants are monitored for safety and effectiveness, including infarct growth and safety endpoints

72 hours

Continuous monitoring

Follow-up

Participants are assessed for clinical outcomes using the modified Rankin Scale

90 days

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Tight control of end-tidal CO2 levels

Trial Overview SEACOAST 1 compares two ways of managing breathing during general anesthesia (GA) in stroke patients undergoing clot removal. One method keeps normal CO2 levels while the other allows slightly higher levels. The study aims to see which method better preserves blood flow in surrounding brain tissue and improves patient outcomes.

How Is the Trial Designed?

Group I: GA with mild hypercarbia (GAH) Active Control 1 Intervention

Controlled ventilation with target end-tidal CO2 levels 50 (±5%)

Group II: GA with normocarbia (GAN) Active Control 1 Intervention

Controlled ventilation with target end-tidal CO2 levels 40 (±5%)

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

University of Southern California

Collaborator

Trials

956

Recruited

1,609,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2277051/

Human cerebrovascular and ventilatory CO2 reactivity to end ... This study examined cerebrovascular reactivity and ventilation during step changes in CO2 in humans. We hypothesized that: (1) end-tidal PCO2 (PET,CO2) ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3835019/

Effect of end-tidal CO2 clamping on cerebrovascular function ... During heavy exercise, hyperventilation-induced hypocapnia leads to cerebral vasoconstriction, resulting in a reduction in cerebral blood flow (CBF).

3. nejm.org nejm.org/doi/full/10.1056/NEJMoa2214552

Mild Hypercapnia or Normocapnia after Out-of-Hospital ... A favorable neurologic outcome at 6 months occurred in 332 of 764 patients (43.5%) in the mild hypercapnia group and in 350 of 784 (44.6%) in ...

4. journals.lww.com journals.lww.com/mgar/fulltext/2020/10020/the_role_of_carbon_dioxide_in_acute_brain_injury.6.aspx

The role of carbon dioxide in acute brain injury The purpose of this review is to summarize the effect of hypocapnia and hypercapnia in stroke and traumatic brain injury.

5. mdpi.com mdpi.com/2077-0383/12/15/4925

Ventilation Targets for Patients Undergoing Mechanical ... This systematic review aims to identify ventilation strategies correlating with better neurological outcomes in AIS patients undergoing MT.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10420130/

Ventilation Targets for Patients Undergoing Mechanical ... The results of the study showed that ETCO2 was significantly associated with the functional outcomes. Specifically, the ETCO2 levels at 60 and 90 min were ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S000709122500529X

Association of intraoperative end-tidal CO2 levels with ... The relationship between intraoperative end-tidal CO2 (etCO2) levels and postoperative outcomes remains unclear. We conducted a post hoc ...

8. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2820841

Temporal Trends in End-Tidal Capnography and ... Temporal increases in end-tidal capnography over resuscitation were associated with return-of-spontaneous circulation in out-of-hospital cardiac arrest.

9. emj.bmj.com emj.bmj.com/content/37/11/674

End-tidal and arterial carbon dioxide gradient in serious ... Current guidance recommends an end-tidal carbon dioxide (ETCO2) of 4.0–4.5 kPa (30.0–33.8 mm Hg) to achieve a low-normal arterial partial pressure of CO2 (PaCO2) ...

10. nature.com nature.com/articles/s41598-021-89913-x

End-tidal to arterial carbon dioxide gradient is associated ... This study demonstrates that the difference between EtCO 2 and PaCO 2 is significantly associated with in-hospital mortality in patients with traumatic brain ...