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

July 23, 2020 updated by: Matias Accoce, Sanatorio Anchorena San Martin

Respiratory System Mechanics and Gas Exchange Characteristics Applying Different Ventilatory Strategies in Patients With SARS-CoV-2

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
    • Buenos Aires
      • San Martin, Buenos Aires, Argentina
        • Recruiting
        • Sanatorio Anchorena San Martín
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Crossover
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
10 minutes
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
10 minutes
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)
10 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanatorio Anchorena San Martin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2020

Primary Completion (Anticipated)

October 10, 2020

Study Completion (Anticipated)

October 20, 2020

Study Registration Dates

First Submitted

July 21, 2020

First Submitted That Met QC Criteria

July 23, 2020

First Posted (Actual)

July 27, 2020

Study Record Updates

Last Update Posted (Actual)

July 27, 2020

Last Update Submitted That Met QC Criteria

July 23, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10.2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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