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

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ClinicalTrials.gov Identifier: NCT04392089
Recruitment Status : Recruiting
First Posted : May 18, 2020
Last Update Posted : May 18, 2020
Sponsor:
Information provided by (Responsible Party):
Ana-Marija Hristovska, Hvidovre University Hospital

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

Condition or disease Intervention/treatment
COVID-19 Respiratory Failure Device: Masimo, LidCO

Detailed Description:

Mechanical ventilation is the cornerstone of supportive management for most ARDS patients to prevent life-threatening hypoxemia. Arterial oxygenation can be improved via ventilator by increasing fractional inspired oxygen (FiO2) and/or increasing mean airway pressure. When treating mechanically ventilated ARDS patients, the benefit of improved arterial oxygenation must be balanced against the potential risk of ventilator-induced lung injury (VILI), oxygen toxicity occurring with high FiO2 and development of right heart failure.

Arterial oxygen saturation target of 88-95 % and partial oxygen pressure (PaO2) target of 7.3-10.6 are advocated in the management of patients with ARDS. Surprisingly little randomized evidence exists to support these values and current recommendations are thus arbitrary and largely based on normal physiologic values.

Given the lack of evidence of strategies in oxygenating critically ill patients to an oxygen saturation and partial oxygen pressure that is generally accepted to be 'normal,' permissive hypoxemia may offer an alternative that has the potential to improve patient outcomes by avoiding unnecessary harm. Permissive hypoxemia is a concept in which a lower level of arterial oxygenation than usual is accepted in order to avoid the potentially detrimental effects of high fractional inspired oxygen and invasive mechanical ventilation with high pressures, while maintaining adequate oxygen delivery by optimizing cardiac output.

Pulse oximetry is a simple, non-invasive and universally used method to monitor peripheral oxygen saturation of hemoglobin in a variety of clinical settings. Pulse oximetry depends on pulsatile blood flow and only measures the oxyhemoglobin in arterial blood as it leaves the heart. However, this measure does not provide information regarding organ or tissue oxygenation, which reflects the important local balance between oxygen supply and demand.

Near-infrared spectroscopy (NIRS) allows for continuous measurement of regional tissue oxygenation which reflects perfusion status and enables clinicians to directly monitor fluctuations in real time. NIRS reflects the balance of oxygen that is delivered minus what is extracted at tissue level and is an indicator of the tissue oxygen uptake.

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effects of Cardiovascular and Pulmonary Optimisation on Cerebral Oxygenation in COVID-19 Patients With Severe ARDS
Actual Study Start Date : May 1, 2020
Estimated Primary Completion Date : May 1, 2021
Estimated Study Completion Date : May 1, 2021

Group/Cohort Intervention/treatment
COVID-19
Mechanically ventilated COVID-19 patients with severe ARDS included within 3 days from time of intubation
Device: Masimo, LidCO
  • 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




Primary Outcome Measures :
  1. Changes in cerebral oxygenation (ScO2) during cardiovascular and pulmonary optimization [ Time Frame: 1 hour ]
    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


Secondary Outcome Measures :
  1. Changes in peripheral oxygen saturation (SatO2) during cardiovascular and pulmonary optimization [ Time Frame: 1 hour ]
    Cardiovascular and pulmonary optimization as described above

  2. Changes in systolic arterial pressure (SAP) during cardiovascular and pulmonary optimization [ Time Frame: 1 hour ]
    Cardiovascular and pulmonary optimization as described above

  3. Changes in diastolic arterial pressure (DAP) during cardiovascular and pulmonary optimization [ Time Frame: 1 hour ]
    Cardiovascular and pulmonary optimization as described above

  4. Changes in mean arterial pressure (MAP) during cardiovascular and pulmonary optimization [ Time Frame: 1 hour ]
    Cardiovascular and pulmonary optimization as described above

  5. Changes in heart rate (HR) during cardiovascular and pulmonary optimization [ Time Frame: 1 hour ]
    Cardiovascular and pulmonary optimization as described above

  6. Changes in stroke volume (SV) during cardiovascular and pulmonary optimization [ Time Frame: 1 hour ]
    Cardiovascular and pulmonary optimization as described above

  7. Changes in cardiac output (CO) during cardiovascular and pulmonary optimization [ Time Frame: 1 hour ]
    Cardiovascular and pulmonary optimization as described above

  8. Changes in systemic vascular resistance (SVR) during cardiovascular and pulmonary optimization [ Time Frame: 1 hour ]
    Cardiovascular and pulmonary optimization as described above

  9. Changes in peripheral perfussion index (PPI) during cardiovascular and pulmonary optimization [ Time Frame: 1 hour ]
    Cardiovascular and pulmonary optimization as described above

  10. Changes in pH during cardiovascular and pulmonary optimization [ Time Frame: 1 hour ]
    Cardiovascular and pulmonary optimization as described above

  11. Changes in PaO2 during cardiovascular and pulmonary optimization [ Time Frame: 1 hour ]
    Cardiovascular and pulmonary optimization as described above

  12. Changes in PaCO2 during cardiovascular and pulmonary optimization [ Time Frame: 1 hour ]
    Cardiovascular and pulmonary optimization as described above

  13. Changes in arterial saturation (SaO2) during cardiovascular and pulmonary optimization [ Time Frame: 1 hour ]
    Cardiovascular and pulmonary optimization as described above

  14. Changes in PvO2 during cardiovascular and pulmonary optimization [ Time Frame: 1 hour ]
    Cardiovascular and pulmonary optimization as described above

  15. Changes in PvCO2 during cardiovascular and pulmonary optimization [ Time Frame: 1 hour ]
    Cardiovascular and pulmonary optimization as described above

  16. Changes in mixed venous saturation (SvO2) during cardiovascular and pulmonary optimization [ Time Frame: 1 hour ]
    Cardiovascular and pulmonary optimization as described above

  17. Changes in lacatate during cardiovascular and pulmonary optimization [ Time Frame: 1 hour ]
    Cardiovascular and pulmonary optimization as described above

  18. Changes in hemoglobine concentration (Hb) during cardiovascular and pulmonary optimization [ Time Frame: 1 hour ]
    Cardiovascular and pulmonary optimization as described above

  19. Changes in muscular oxygenation (SmO2) during cardiovascular and pulmonary optimization [ Time Frame: 1 hour ]
    Cardiovascular and pulmonary optimization as described above

  20. Association between cerebral oxygenation (ScO2) and peripheral oxygen saturation (SatO2) during cardiovascular and pulmonary optimization [ Time Frame: 1 hour ]
    Cardiovascular and pulmonary optimization as described above

  21. Association between cerebral oxygenation (ScO2) and systemic arterial pressure (SAP) during cardiovascular and pulmonary optimization [ Time Frame: 1 hour ]
    Cardiovascular and pulmonary optimization as described above

  22. Association between cerebral oxygenation (ScO2) and diastolic arterial pressure (DAP) during cardiovascular and pulmonary optimization [ Time Frame: 1 hour ]
    Cardiovascular and pulmonary optimization as described above

  23. Association between cerebral oxygenation (ScO2) and mean arterial pressure (MAP) during cardiovascular and pulmonary optimization [ Time Frame: 1 hour ]
    Cardiovascular and pulmonary optimization as described above

  24. Association between cerebral oxygenation (ScO2) and stroke volume (SV) during cardiovascular and pulmonary optimization [ Time Frame: 1 hour ]
    Cardiovascular and pulmonary optimization as described above

  25. Association between cerebral oxygenation (ScO2) and heart rate (HR) during cardiovascular and pulmonary optimization [ Time Frame: 1 hour ]
    Cardiovascular and pulmonary optimization as described above

  26. Association between cerebral oxygenation (ScO2) and cardiac output (CO) during cardiovascular and pulmonary optimization [ Time Frame: 1 hour ]
    Cardiovascular and pulmonary optimization as described above

  27. Association between cerebral oxygenation (ScO2) and systemic vascular resistance (SVR) during cardiovascular and pulmonary optimization [ Time Frame: 1 hour ]
    Cardiovascular and pulmonary optimization as described above

  28. Association between cerebral oxygenation (ScO2) and peripheral perfussion index (PPI) during cardiovascular and pulmonary optimization [ Time Frame: 1 hour ]
    Cardiovascular and pulmonary optimization as described above

  29. Association between cerebral oxygenation (ScO2) and pH during cardiovascular and pulmonary optimization [ Time Frame: 1 hour ]
    Cardiovascular and pulmonary optimization as described above

  30. Association between cerebral oxygenation (ScO2) and PaO2 during cardiovascular and pulmonary optimization [ Time Frame: 1 hour ]
    Cardiovascular and pulmonary optimization as described above

  31. Association between cerebral oxygenation (ScO2) and PaCO2 during cardiovascular and pulmonary optimization [ Time Frame: 1 hour ]
    Cardiovascular and pulmonary optimization as described above

  32. Association between cerebral oxygenation (ScO2) and arterial saturation (SaO2) during cardiovascular and pulmonary optimization [ Time Frame: 1 hour ]
    Cardiovascular and pulmonary optimization as described above

  33. Association between cerebral oxygenation (ScO2) and PvO2 during cardiovascular and pulmonary optimization [ Time Frame: 1 hour ]
    Cardiovascular and pulmonary optimization as described above

  34. Association between cerebral oxygenation (ScO2) and PvCO2 during cardiovascular and pulmonary optimization [ Time Frame: 1 hour ]
    Cardiovascular and pulmonary optimization as described above

  35. Association between cerebral oxygenation (ScO2) and mixed venous saturation (SvO2) during cardiovascular and pulmonary optimization [ Time Frame: 1 hour ]
    Cardiovascular and pulmonary optimization as described above

  36. Association between cerebral oxygenation (ScO2) and lactate during cardiovascular and pulmonary optimization [ Time Frame: 1 hour ]
    Cardiovascular and pulmonary optimization as described above

  37. Association between cerebral oxygenation (ScO2) and hemoglobine concentration (Hb) during cardiovascular and pulmonary optimization [ Time Frame: 1 hour ]
    Cardiovascular and pulmonary optimization as described above

  38. Association between cerebral oxygenation (ScO2) and muscular oxygenation (SmO2) during cardiovascular and pulmonary optimization [ Time Frame: 1 hour ]
    Cardiovascular and pulmonary optimization as described above



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Mechanically ventilated COVID-19 patients with severe ARDS included within 3 days from time of intubation
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04392089


Contacts
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Contact: Ana-Marija Hristovska, MD, Ph.d.-student +4538625532 ana-marija.hristovska.02@regionh.dk

Locations
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Denmark
Hvidovre Hospital Recruiting
Copenhagen, Denmark
Contact: Ana-Marija Hristovska, MD         
Sponsors and Collaborators
Hvidovre University Hospital

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Responsible Party: Ana-Marija Hristovska, MD, Ph.d-student, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT04392089    
Other Study ID Numbers: H-20027818
First Posted: May 18, 2020    Key Record Dates
Last Update Posted: May 18, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ana-Marija Hristovska, Hvidovre University Hospital:
COVID-19
ARDS
NIRS
Saturation
Additional relevant MeSH terms:
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Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases