Effects of Cardiovascular and Pulmonary Optimization on Cerebral Oxygenation in COVID-19 Patients With Severe ARDS

NCT04392089 | Unknown

• 1 other identifier: H-20027818
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the present study is to examine whether cerebral oxygenation could be a more useful parameter than peripheral oxygen saturation to guide clinical titration of permissive hypoxemia in COVID-19 ARDS patients

Conditions

COVID-19; Respiratory Failure

Keywords

COVID-19; ARDS; NIRS; Saturation

Outcome Measures

Primary Outcomes (1)

• Changes in cerebral oxygenation (ScO2) during cardiovascular and pulmonary optimization

  Cardiovascular and pulmonary optimization: Step 0 = Baseline, Step 1 = Derecruitment, Step 2 = Recruitment, Step 3 = Norepinephrine challenge, Step 4 = FiO2 increase, Step 5 = FiO2 decrease, Step 6 = Baseline 2

  1 hour

Secondary Outcomes (38)

• Changes in peripheral oxygen saturation (SatO2) during cardiovascular and pulmonary optimization

  1 hour

• Changes in systolic arterial pressure (SAP) during cardiovascular and pulmonary optimization

  1 hour

• Changes in diastolic arterial pressure (DAP) during cardiovascular and pulmonary optimization

  1 hour

• Changes in mean arterial pressure (MAP) during cardiovascular and pulmonary optimization

  1 hour

• Changes in heart rate (HR) during cardiovascular and pulmonary optimization

  1 hour

Study Arms (1)

COVID-19

Mechanically ventilated COVID-19 patients with severe ARDS included within 3 days from time of intubation

Device: Masimo, LidCO

Interventions

Masimo, LidCO DEVICE

* Near-infrared spectroscopy (NIRS), pulse oxymetry (saturation), continous hemoglobine, peripheral perfusion index (PPI) as measured with Massimo * Systolic arterial pressure (SAP), diastolic arterial pressure (DAP), mean arterial pressure (MAP), stroke volume (SV), heart rate (HR), cardiac output (CO), systemic vascular resistance (SVR) as measured with LiDCO

COVID-19

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Mechanically ventilated COVID-19 patients with severe ARDS included within 3 days from time of intubation

You may qualify if:

• Age ≥ 18 years
• Verified COVID-19 infection (throat swab or tracheal aspirate positive for SARS-CoV-2)
• Severe ARDS according to Berlin definition
• Ventilator settings: Controlled IPPV, FiO2 \> 0.70, PEEP \> 10
• Norepinephrine infusion
• SVV \< 10% measured by LiDCO
• RASS - 5

You may not qualify if:

• Any of the following contraindications to lung recruitment: pneumothorax, patients on ventilator \> 1 week
• Patients with dark pigmented skin

Sponsors & Collaborators

• Hvidovre University Hospital: lead

Study Sites (1)

Hvidovre Hospital

Copenhagen, Denmark

RECRUITING

MeSH Terms

Conditions

COVID-19; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Central Study Contacts

Ana-Marija Hristovska, MD, Ph.d.-student

CONTACT

+4538625532; ana-marija.hristovska.02@regionh.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Ph.d-student

Study Record Dates

• First Submitted: May 14, 2020
• First Posted: May 18, 2020
• Study Start: May 1, 2020
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2021
• Last Updated: May 18, 2020

Record last verified: 2020-05

Locations

DK (1)