Effects in Oxygenation and Hypoxic Pulmonary Vasoconstriction in ARDS Secondary to SARS-CoV2

• Status: Completed
• Trial end date: 2021-05-15
• Target enrollment: 0
• Participant gender: All

Summary

Summary Currently, the COVID-19 pandemic has overtaken health systems worldwide, exceeding the capacity of intensive care units. In addition to this, countries such as the United States have reported a decrease in the supplies of drugs such as Propofol and Midazolam (traditionally used as sedatives in patients with invasive mechanical ventilation), so in the absence until now of a specific treatment against SARS-COV-2 virus, improving the support strategies in patients in the severe spectrum of the disease Acute Respiratory Distress Syndrome (ARDS) is a priority.

Given the global state of emergency due to COVID-19, the use of sevoflurane has the potential to mitigate the shortages of sedative drugs, promote the recovery of patients with ARDS, and potentially reduce mortality.

A study will be conducted to evaluate the effect of sevoflurane as inhalation sedation in patients with ARDS secondary to SARS-COV2 compared to the standard. The primary objective of the study is to assess the difference in oxygenation, for which the calculation of the partial pressure of arterial oxygen to fractional inspired oxygen concentration ratio (PaO2 / FiO2) will be used at 24 and 48 hours. Also, the effect of the possible attenuation or inhibition of hypoxic pulmonary vasoconstriction will be evaluated by hemodynamic monitoring with a pulmonary artery catheter and transthoracic echocardiography and its possible effect on the right ventricle.

Outcome: we expect an improvement in oxygenation and consequently a reduction in the days of invasive mechanical ventilation, stay in the intensive care unit (ICU) and hospital. In addition to evaluating its possible anti-inflammatory effect and probably establishing a safe and effective alternative and possibly with greater benefits compared to standard intravenous sedation.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Unidad Temporal COVID-19 en Centro Citibanamex
• Treatments: Anti-Inflammatory Agents; Propofol; Sevoflurane

Criteria

Inclusion Criteria:

1. Over 18 years

2. Both genders

3. Diagnosis of COVID-19 (SARS-COV2) with moderate to severe ARDS from the Berlin classification (PaO2 / FiO2: < 200).

Exclusion Criteria:

1. Acute kidney failure.

2. Severe liver failure

3. Suspected or documented intracranial hypertension.

4. Family history of malignant hyperthermia.

5. History of malignant hyperthermia.

6. Documented chronic lung disease.

7. Documented chronic pulmonary hypertension

8. Patients who do not sign informed consent.