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Respiratory Mechanics and Gas Exchange Characteristics in Patient With SARS-CoV-2

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ClinicalTrials.gov Identifier: NCT04486729
Recruitment Status : Recruiting
First Posted : July 27, 2020
Last Update Posted : July 27, 2020
Sponsor:
Information provided by (Responsible Party):
Matias Accoce, Sanatorio Anchorena San Martin

Study Description
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Brief Summary:
The combination of different ventilatory strategies and its effects on respiratory mechanics and gas exchange in patients under mechanical ventilation with acute respiratory distress syndrome secondary to coronavirus-19 has been scarcely described.

Condition or disease Intervention/treatment
Covid19 ARDS, Human Other: High PEEP with end inspiratory pause Other: Low PEEP - FiO2 high Other: High PEEP without end inspiratory pause Other: Low PEEP - FiO2 low

Detailed Description:

Investigation in mechanically ventilated patients with with acute respiratory distress syndrome (ARDS) secondary to coronavirus-19 (COVID-19) is emerging due to presumed differences with typical ARDS from other origin. Considering these issues, the effects of ventilatory strategies such as positive end expiratory pressure, end inspiratory pause and fraction of inspired oxygen on respiratory mechanics and gas exchange must be studied in order to characterize the behavior of COVID-19 ARDS during invasive mechanical ventilation and choose the best combination of ventilatory settings.

In this study the investigators will evaluate the changes in respiratory mechanics and gas exchange produced by low and high positive end expiratory pressure, low and high inspired oxygen fraction and the application of end inspiratory pause during volume controlled mechanical ventilation.

Study Design
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Study Type : Observational
Estimated Enrollment : 15 participants
Observational Model: Case-Crossover
Time Perspective: Cross-Sectional
Official Title: Respiratory System Mechanics and Gas Exchange Characteristics Applying Different Ventilatory Strategies in Patients With SARS-CoV-2
Actual Study Start Date : July 1, 2020
Estimated Primary Completion Date : October 10, 2020
Estimated Study Completion Date : October 20, 2020

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Groups and Cohorts
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Intervention Details:
  • Other: High PEEP with end inspiratory pause
    Applying a PEEP value 10 cmH2O higher than the lower inflection point of the pressure-volume curve of the respiratory system with end inspiratory pause addition in volumen control ventilation
  • Other: Low PEEP - FiO2 high
    Applying a PEEP value equal to the lower inflection point of the pressure-volume curve of the respiratory system with a FiO2 necessary to achieve a SpO2 96-98%
  • Other: High PEEP without end inspiratory pause
    Applying a PEEP value 10 cmH2O higher than the lower inflection point of the pressure-volume curve of the respiratory system without end inspiratory pause addition in volumen control ventilation
  • Other: Low PEEP - FiO2 low
    Applying a PEEP value equal to the lower inflection point of the pressure-volume curve of the respiratory system with a FiO2 necessary to achieve a SpO2 88-92%

Outcome Measures
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Primary Outcome Measures :
  1. Driving transpulmonary pressure (cmH2O) [ Time Frame: 10 minutes ]
    The driving transpulmonary pressure will be evaluated between the high and low PEEP condition using the formula: driving transpulmonary pressure = driving airway pressure - driving esophageal pressure (cmH2O).

  2. Bohr dead space fraction (%) [ Time Frame: 10 minutes ]
    The Bohr dead space fraction will be evaluated with high PEEP between the condition with end inspiratory pause and with no end inspiratory pause application using the formula: Bohr dead space fraction = Alveolar pressure of CO2 (PACO2) - Expired pressure of CO2 (PECO2) / PACO2

  3. Shunt fraction (%) [ Time Frame: 10 minutes ]
    The shunt fraction will be evaluated with low PEEP between the condition with high fraction of oxygen to achieve a saturation goal of 96-98% and the condition with low fraction of oxygen to achieve a saturation goal of 88-92%. The shunt fraction will be calculated using the formula: Qs/Qt = (capillary oxygen content - arterial oxygen content)/(capillary oxygen content - venous oxygen content)


Eligibility Criteria
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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
Patients with ARDS secondary to COVID-19 under invasive mechanical ventilation
Criteria

Inclusion Criteria:

  • Older than 18 years old
  • less than 72 hs since ARDS diagnosis
  • Moderate to severe ARDS
  • central venous catheter and arterial line available
  • Need of neuromuscular blocking agents
  • Supine position
  • Informed consent accepted
  • Airway opening pressure lower than 20 cmH2O

Exclusion Criteria:

  • RASS target higher than -5
  • COPD diagnosis
  • Pneumothorax
  • Intracraneal Hypertension
  • Pregnancy
  • Cardiac inssuficiency uncompensated
  • Chest wall deformity
  • Bronchopleural fistula
  • Contraindication to use esophageal manometry
Contacts and Locations
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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): NCT04486729


Contacts
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Contact: Javier H Dorado, PT (054) 114164 4262 javierhdorado@gmail.com
Contact: Joaquin Pérez, PT (054) 02245 505907 licjoaquinperez@hotmail.com

Locations
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Argentina
Sanatorio Anchorena San Martin Recruiting
San Martin, Buenos Aires, Argentina
Contact: Javier H Dorado, PT    (054) 1141644262    javierhdorado@gmail.com   
Sponsors and Collaborators
Sanatorio Anchorena San Martin
More Information
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Publications:

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Responsible Party: Matias Accoce, Head of physical therapy department, Sanatorio Anchorena San Martin
ClinicalTrials.gov Identifier: NCT04486729    
Other Study ID Numbers: 10.2020
First Posted: July 27, 2020    Key Record Dates
Last Update Posted: July 27, 2020
Last Verified: July 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
Additional relevant MeSH terms:
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Respiratory Distress Syndrome
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders