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Breathing Effort in Covid-19 Pneumonia: Effects of Positive Pressure, Inspired Oxygen Fraction and Decubitus

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ClinicalTrials.gov Identifier: NCT04885517
Recruitment Status : Recruiting
First Posted : May 13, 2021
Last Update Posted : May 14, 2021
Sponsor:
Information provided by (Responsible Party):
Pietro Caironi, San Luigi Gonzaga Hospital

Study Description
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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-19 pneumonia (at different disease stages) and in other causes of respiratory failure. The hypothesis is that positive pressure might be deleterious in terms of breathing effort if the main pathological mechanism associated with Sars-CoV-2 infection in the lung is not alveolar damage (as in other causes of respiratory failure) but vascular impairment as previously reported. The effects of high inspired oxygen fractions and decubiti might also be different with respect to other causes of respiratory failure.

Condition or disease Intervention/treatment Phase
COVID-19 Pneumonia Device: Esophageal catheter Not Applicable

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 oxygenation improvement associated with proning and/or continuous positive airway pressure) seem to line up with other causes of pneumonia characterized by primary alveolar damage, specific characteristics have been reported about Sars-CoV-2 lung infection which suggest a certain degree of parenchymal preservation and a predominant role of vascular impairment: the dissociation between lung volume and gas exchange, and the so called "happy hypoxemia" both evoke the possibility of mechanisms other than the loss of aeration as causes of hypoxia. Accordingly, evidence are now growing on the role of vascular dysregulation in this regard. It is probable, as previously put forward, that different stages exist in the disease which may account for the discordant findings of previous studies seeking to either associate or separate Covid-19 pneumonia and other causes of respiratory failure. In the present study we will compare the effects of three currently used approaches to improve gas exchange (continuous positive airway pressure, external oxygen administration and decubiti variations) in three different populations (1) early Covid-19 pneumonia, 2) severe late Covid-19 pneumonia and 3) non-Covid-19 pneumonia) in terms of breathing effort as assessed by esophageal pressure swings: our aim is to evaluate, in these populations, the real benefits (beyond the previously reported ones on gas exchange) of such strategies on lung rest. Our hypothesis is that, at least in the early stages of Covid-19 (and as opposed to other causes of respiratory failure), the application of positive pressure might be deleterious if no potential for recruitment, but rather a primary vascular impairment, is associated with hypoxia. If this will be the case the same (or a similar) degree of oxygenation improvement and a safer pattern of ventilation might be attained with the simple administration of oxygen or decubiti variations without the application of positive pressure, thus completely changing the current standards for the treatment of Covid-19 pneumonia.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Dynamic Transpulmonary Pressure in Covid-19 Pneumonia: Effects of Positive Pressure, Inspired Oxygen Fraction and Decubitus
Actual Study Start Date : February 1, 2021
Estimated Primary Completion Date : August 1, 2021
Estimated Study Completion Date : August 1, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Spontaneous breathing, Venturi Mask FiO2 0.5, seated decubitus
Patient will be evaluated after 20 minutes of spontaneous breathing, with FiO2 0.5 (Venturi Mask), during seated decubitus. Respiratory, haemodynamics, and data on blood gas analysis will be obtained.
 Device: Esophageal catheter
Patients are equipped with an esophageal catheter: positioning is performed after accurate nasopharyngeal anesthesia with lidocaine
Experimental: Spontaneous breathing, Non Rebreathing Mask, seated decubitus
Patient will be evaluated after 20 minutes of spontaneous breathing, with FiO2 1 (Non Rebreathing Mask), during seated decubitus. Respiratory, haemodynamics, and data on blood gas analysis will be obtained.
 Device: Esophageal catheter
Patients are equipped with an esophageal catheter: positioning is performed after accurate nasopharyngeal anesthesia with lidocaine
Experimental: Continuous Positive Airway Pressure (CPAP) 7 cmH2O, FiO2 0.5, seated decubitus
Patient will be evaluated after 20 minutes of CPAP (7 cmH2O), with FiO2 0.5, during seated decubitus. Respiratory, haemodynamics, and data on blood gas analysis will be obtained.
 Device: Esophageal catheter
Patients are equipped with an esophageal catheter: positioning is performed after accurate nasopharyngeal anesthesia with lidocaine
Experimental: Continuous Positive Airway Pressure (CPAP) 7 cmH2O, FiO2 0.5, supine decubitus
Patient will be evaluated after 20 minutes of CPAP (7 cmH2O), with FiO2 0.5, during supine decubitus. Respiratory, haemodynamics, and data on blood gas analysis will be obtained.
 Device: Esophageal catheter
Patients are equipped with an esophageal catheter: positioning is performed after accurate nasopharyngeal anesthesia with lidocaine
Experimental: Continuous Positive Airway Pressure (CPAP) 7 cmH2O, FiO2 0.5, prone decubitus
Patient will be evaluated after 20 minutes of CPAP (7 cmH2O), with FiO2 0.5, during prone decubitus. Respiratory, haemodynamics, and data on blood gas analysis will be obtained.
 Device: Esophageal catheter
Patients are equipped with an esophageal catheter: positioning is performed after accurate nasopharyngeal anesthesia with lidocaine
Experimental: Continuous Positive Airway Pressure (CPAP) 7 cmH2O, FiO2 1, seated decubitus
Patient will be evaluated after 20 minutes of CPAP (7 cmH2O), with FiO2 1.0, during seated decubitus. Respiratory, haemodynamics, and data on blood gas analysis will be obtained.
 Device: Esophageal catheter
Patients are equipped with an esophageal catheter: positioning is performed after accurate nasopharyngeal anesthesia with lidocaine
Experimental: Continuous Positive Airway Pressure (CPAP) 12 cmH2O, FiO2 0.5, seated decubitus
Patient will be evaluated after 20 minutes of CPAP (12 cmH2O), with FiO2 0.5, during seated decubitus. Respiratory, haemodynamics, and data on blood gas analysis will be obtained.
 Device: Esophageal catheter
Patients are equipped with an esophageal catheter: positioning is performed after accurate nasopharyngeal anesthesia with lidocaine
Experimental: Continuous Positive Airway Pressure (CPAP) 12 cmH2O, FiO2 1, seated decubitus
Patient will be evaluated after 20 minutes of CPAP (7 cmH2O), with FiO2 1.0, during seated decubitus. Respiratory, haemodynamics, and data on blood gas analysis will be obtained.
 Device: Esophageal catheter
Patients are equipped with an esophageal catheter: positioning is performed after accurate nasopharyngeal anesthesia with lidocaine


Outcome Measures
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Primary Outcome Measures :
  1. Esophageal pressure swings at different levels of positive end-expiratory pressure (PEEP) [ Time Frame: 160 minutes ]
    The main outcome of the study is represented by the difference in esophageal pressure swings (expiratory minus inspiratory) between the three levels of end expiratory pressure applied (0-7-12 cmH2O)


Secondary Outcome Measures :
  1. Esophageal pressure swings at different levels of inspired oxygen fraction [ Time Frame: 160 minutes ]
    One of the secondary outcomes of the study is represented by the difference in esophageal pressure swings (expiratory minus inspiratory) between the two levels of FiO2 applied (0.5-1)

  2. Esophageal pressure swings at different decubiti [ Time Frame: 160 minutes ]
    One of the secondary outcomes of the study is represented by the difference in esophageal pressure swings (expiratory minus inspiratory) between the three decubiti applied (seated, supine, prone)


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
Criteria

Inclusion Criteria:

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 Criteria:

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)
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): NCT04885517


Contacts
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Contact: Pietro Caironi, Pr +390119026386 pietro.caironi@unito.it

Locations
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Italy
A.O.U. San Luigi Gonzaga Di Orbassano Recruiting
Orbassano, Italy/Turin, Italy, 10043
Contact: Pietro Caironi, Pr    +390119026386    pietro.caironi@unito.it   
Sponsors and Collaborators
San Luigi Gonzaga Hospital
Investigators
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Principal Investigator: Pietro Caironi, MD San Luigi Gonzaga Hospital
Principal Investigator: Lorenzo Giosa, MD San Luigi Gonzaga Hospital
More Information
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Publications of Results:

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Responsible Party: Pietro Caironi, Professor, San Luigi Gonzaga Hospital
ClinicalTrials.gov Identifier: NCT04885517    
Other Study ID Numbers: 2782
First Posted: May 13, 2021    Key Record Dates
Last Update Posted: May 14, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Pietro Caironi, San Luigi Gonzaga Hospital:
COVID-19 Pneumonia
Esophageal Pressure
Respiratory Drive
Additional relevant MeSH terms:
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COVID-19
Pneumonia
Respiratory Tract Infections
Infections
Pneumonia, Viral
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases