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

• Conditions: Covid19; ARDS, Human

• Registration Number: NCT04486729
• Lead Sponsor: Sanatorio Anchorena San Martin

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.

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 Timeline

• Status Verified: 2020-07
• Study Start: 2020-07-01
• Study First Submitted: 2020-07-21
• Study First Submitted QC: 2020-07-23
• Last Update Submitted: 2020-07-23
• Study First Posted: 2020-07-27
• Last Update Posted: 2020-07-27
• Primary Completion: 2020-10-10
• Study Completion: 2020-10-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Driving transpulmonary pressure (cmH2O)	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).
Bohr dead space fraction (%)	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
Shunt fraction (%)	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)

Trial Locations

Locations (1)

Sanatorio Anchorena San Martin; 🇦🇷 San Martin, Buenos Aires, Argentina