Status:
UNKNOWN
Breathing Effort in Covid-19 Pneumonia: Effects of Positive Pressure, Inspired Oxygen Fraction and Decubitus
Lead Sponsor:
San Luigi Gonzaga Hospital
Conditions:
COVID-19 Pneumonia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The study investigates the role of positive pressure, inspired oxygen fraction and different decubiti (seated, supine, prone) on breathing effort (as assessed by esophageal pressure swings) in Covid-1...
Detailed Description
In spite of the overwhelming numbers of the current pandemic, many questions remain open regarding the pathophysiology of Covid-19 associated pneumonia. While some features of the disease (such as the...
Eligibility Criteria
Inclusion
- Group 1 (Covid-19 early pneumonia)
- Age \> 18
- Positive Sars-CoV 2 nasal swab
- interstitial pneumonia at either CT scan or chest X-ray
- Respiratory failure requiring CPAP for less than 48 hours
- FiO2 ≤0.5 and CPAP≤10 cmH2O
- Group 2 (Covid-19 severe pneumonia)
- Age \> 18
- Positive Sars-CoV 2 nasal swab
- interstitial pneumonia at either CT scan or chest X-ray
- Respiratory failure requiring CPAP
- Signs of severity with CPAP 10 cmH2O and FiO2 0.5: pulse oximetry (SpO2) ≤ 93% associated to either:
- Dyspnea
- Two or more signs of increased respiratory effort (respiratory rate ≥25 bpm, use of accessory inspiratory muscles , tirage, intercostal space depression, nasal flaring, expiratory abdominal efforts, PaCO2 \< 35)
- Group 3 (Non Covid-19 pneumonia)
- Age \> 18
- Negative Sars-CoV 2 nasal swab
- CT scan or chest X-ray non compatible with Covid-19 associated pneumonia
- Respiratory failure requiring CPAP
Exclusion
- Group 1 (Covid-19 early pneumonia)
- Concomitant chronic pulmonary disease
- Chronic heart failure New York Heart Association (NYHA) 3-4
- Bacterial pulmonary associated infection (diagnosed or suspected)
- Pulmonary embolism
- Acute cardiogenic pulmonary edema
- Signs of severity with CPAP 10 cmH2O and FiO2 0.5: SpO2≤ 93% associated to either:
- Dyspnea
- Two or more signs of increased respiratory effort (respiratory rate ≥25 bpm, use of accessory inspiratory muscles , tirage, intercostal space depression, nasal flaring, expiratory abdominal efforts, PaCO2 \< 35)
- At least one sign of respiratory fatigue/decompensation (pH\<7.30 with PaCO2 \>45, respiratory rate \<15 bpm, paradoxal abdominal breathing, mental status alteration)
- Group 2 (Covid-19 severe pneumonia)
- Concomitant chronic pulmonary disease
- Chronic heart failure NYHA 3-4
- Bacterial pulmonary associated infection (diagnosed or suspected)
- Pulmonary embolism
- Acute cardiogenic pulmonary edema
- At least one sign of respiratory fatigue/decompensation (pH\<7.30 with PaCO2 \>45, respiratory rate \<15 bpm, paradoxal abdominal breathing, mental status alteration)
- Group 3 (Non Covid-19 pneumonia)
- Concomitant chronic pulmonary disease
- Chronic heart failure NYHA 3-4
- Bacterial pulmonary associated infection (diagnosed or suspected)
- Pulmonary embolism
- Acute cardiogenic pulmonary edema
- At least one sign of respiratory fatigue/decompensation (pH\<7.30 with PaCO2 \>45, respiratory rate \<15 bpm, paradoxal abdominal breathing, mental status alteration)
Key Trial Info
Start Date :
February 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2021
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT04885517
Start Date
February 1 2021
End Date
August 1 2021
Last Update
May 14 2021
Active Locations (1)
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1
A.O.U. San Luigi Gonzaga Di Orbassano
Orbassano, Italy/Turin, Italy, 10043