Respiratory Mechanics and Gas Exchange Characteristics in Patient With SARS-CoV-2
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04486729 |
Recruitment Status : Unknown
Verified July 2020 by Matias Accoce, Sanatorio Anchorena San Martin.
Recruitment status was: Recruiting
First Posted : July 27, 2020
Last Update Posted : July 27, 2020
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |
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 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 |

- 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%
- 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).
- 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
- 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)

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
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 |
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

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
Contact: Javier H Dorado, PT | (054) 114164 4262 | javierhdorado@gmail.com | |
Contact: Joaquin Pérez, PT | (054) 02245 505907 | licjoaquinperez@hotmail.com |
Argentina | |
Sanatorio Anchorena San Martin | Recruiting |
San Martin, Buenos Aires, Argentina | |
Contact: Javier H Dorado, PT (054) 1141644262 javierhdorado@gmail.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Respiratory Distress Syndrome Lung Diseases Respiratory Tract Diseases Respiration Disorders |