COVID-19 PneumoniaNCT04885517
Breathing Effort in Covid-19 Pneumonia: Effects of Positive Pressure, Inspired Oxygen Fraction and Decubitus
A study testing Esophageal catheter in people with COVID-19 Pneumonia, run by San Luigi Gonzaga Hospital at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19 Pneumonia
- What is being tested?
- Esophageal catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2021to 1 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 19Show fewer
- 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
Who cannot join
- 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
Show all 24Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
A.O.U. San Luigi Gonzaga Di Orbassano
Orbassano, Italy/Turin, 10043
Pietro Caironi, Pr, +390119026386, pietro.caironi@unito.it
About this study
Official title: Dynamic Transpulmonary Pressure in Covid-19 Pneumonia: Effects of Positive Pressure, Inspired Oxygen Fraction and Decubitus
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.
Read the 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.
- Conditions
- COVID-19 Pneumonia
- Being tested
- Esophageal catheter
- Keywords
- COVID-19 Pneumonia, Esophageal Pressure, Respiratory Drive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esophageal catheterDevice
Patients are equipped with an esophageal catheter: positioning is performed after accurate nasopharyngeal anesthesia with lidocaine
| Study group | Role | What they receive |
|---|---|---|
| Spontaneous breathing, Venturi Mask FiO2 0.5, seated decubitus | Experimental | 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. Receives: Device: Esophageal catheter |
| Spontaneous breathing, Non Rebreathing Mask, seated decubitus | Experimental | 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. Receives: Device: Esophageal catheter |
| Continuous Positive Airway Pressure (CPAP) 7 cmH2O, FiO2 0.5, seated decubitus | Experimental | 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. Receives: Device: Esophageal catheter |
| Continuous Positive Airway Pressure (CPAP) 7 cmH2O, FiO2 0.5, supine decubitus | Experimental | 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. Receives: Device: Esophageal catheter |
| Continuous Positive Airway Pressure (CPAP) 7 cmH2O, FiO2 0.5, prone decubitus | Experimental | 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. Receives: Device: Esophageal catheter |
| Continuous Positive Airway Pressure (CPAP) 7 cmH2O, FiO2 1, seated decubitus | Experimental | 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. Receives: Device: Esophageal catheter |
| Continuous Positive Airway Pressure (CPAP) 12 cmH2O, FiO2 0.5, seated decubitus | Experimental | 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. Receives: Device: Esophageal catheter |
| Continuous Positive Airway Pressure (CPAP) 12 cmH2O, FiO2 1, seated decubitus | Experimental | 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. Receives: Device: Esophageal catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Esophageal pressure swings at different levels of positive end-expiratory pressure (PEEP)
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)
Measured: 160 minutes
Secondary outcomes (2)
Esophageal pressure swings at different levels of inspired oxygen fraction
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)
Measured: 160 minutes
Esophageal pressure swings at different decubiti
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)
Measured: 160 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2021
- Study start1 Feb 2021
- Primary completion1 Aug 2021 (estimated)
- Study completion1 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for COVID-19 PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- San Luigi Gonzaga Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pietro Caironi, San Luigi Gonzaga Hospital
- Investigators
- Pietro Caironi, MD, Principal investigator, San Luigi Gonzaga HospitalLorenzo Giosa, MD, Principal investigator, San Luigi Gonzaga Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04885517
- Sponsor's protocol ID
- 2782
- Status last verified
- May 2021
- First submitted
- 11 May 2021
- Last updated
- 14 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gattinoni L, Coppola S, Cressoni M, Busana M, Rossi S, Chiumello D. COVID-19 Does Not Lead to a "Typical" Acute Respiratory Distress Syndrome. Am J Respir Crit Care Med. 2020 May 15;201(10):1299-1300. doi: 10.1164/rccm.202003-0817LE. No abstract available.
PubMed 32228035Couzin-Frankel J. The mystery of the pandemic's 'happy hypoxia'. Science. 2020 May 1;368(6490):455-456. doi: 10.1126/science.368.6490.455. No abstract available.
PubMed 32355007Aliberti S, Radovanovic D, Billi F, Sotgiu G, Costanzo M, Pilocane T, Saderi L, Gramegna A, Rovellini A, Perotto L, Monzani V, Santus P, Blasi F. Helmet CPAP treatment in patients with COVID-19 pneumonia: a multicentre cohort study. Eur Respir J. 2020 Oct 15;56(4):2001935. doi: 10.1183/13993003.01935-2020. Print 2020 Oct.
PubMed 32747395Elharrar X, Trigui Y, Dols AM, Touchon F, Martinez S, Prud'homme E, Papazian L. Use of Prone Positioning in Nonintubated Patients With COVID-19 and Hypoxemic Acute Respiratory Failure. JAMA. 2020 Jun 9;323(22):2336-2338. doi: 10.1001/jama.2020.8255.
PubMed 32412581Chiumello D, Busana M, Coppola S, Romitti F, Formenti P, Bonifazi M, Pozzi T, Palumbo MM, Cressoni M, Herrmann P, Meissner K, Quintel M, Camporota L, Marini JJ, Gattinoni L. Physiological and quantitative CT-scan characterization of COVID-19 and typical ARDS: a matched cohort study. Intensive Care Med. 2020 Dec;46(12):2187-2196. doi: 10.1007/s00134-020-06281-2. Epub 2020 Oct 21.
PubMed 33089348Marini JJ, Gattinoni L. Management of COVID-19 Respiratory Distress. JAMA. 2020 Jun 9;323(22):2329-2330. doi: 10.1001/jama.2020.6825. No abstract available.
PubMed 32329799Poston JT, Patel BK, Davis AM. Management of Critically Ill Adults With COVID-19. JAMA. 2020 May 12;323(18):1839-1841. doi: 10.1001/jama.2020.4914. No abstract available.
PubMed 32215647Gattinoni L, Giosa L, Bonifazi M, Pasticci I, Busana M, Macri M, Romitti F, Vassalli F, Quintel M. Targeting transpulmonary pressure to prevent ventilator-induced lung injury. Expert Rev Respir Med. 2019 Aug;13(8):737-746. doi: 10.1080/17476348.2019.1638767. Epub 2019 Jul 5.
PubMed 31274034Brochard L, Slutsky A, Pesenti A. Mechanical Ventilation to Minimize Progression of Lung Injury in Acute Respiratory Failure. Am J Respir Crit Care Med. 2017 Feb 15;195(4):438-442. doi: 10.1164/rccm.201605-1081CP.
PubMed 27626833Tonelli R, Fantini R, Tabbi L, Castaniere I, Pisani L, Pellegrino MR, Della Casa G, D'Amico R, Girardis M, Nava S, Clini EM, Marchioni A. Early Inspiratory Effort Assessment by Esophageal Manometry Predicts Noninvasive Ventilation Outcome in De Novo Respiratory Failure. A Pilot Study. Am J Respir Crit Care Med. 2020 Aug 15;202(4):558-567. doi: 10.1164/rccm.201912-2512OC.
PubMed 32325004Goligher EC, Jonkman AH, Dianti J, Vaporidi K, Beitler JR, Patel BK, Yoshida T, Jaber S, Dres M, Mauri T, Bellani G, Demoule A, Brochard L, Heunks L. Clinical strategies for implementing lung and diaphragm-protective ventilation: avoiding insufficient and excessive effort. Intensive Care Med. 2020 Dec;46(12):2314-2326. doi: 10.1007/s00134-020-06288-9. Epub 2020 Nov 2.
PubMed 33140181Apigo M, Schechtman J, Dhliwayo N, Al Tameemi M, Gazmuri RJ. Development of a work of breathing scale and monitoring need of intubation in COVID-19 pneumonia. Crit Care. 2020 Jul 31;24(1):477. doi: 10.1186/s13054-020-03176-y. No abstract available.
PubMed 32736637Vaporidi K, Akoumianaki E, Telias I, Goligher EC, Brochard L, Georgopoulos D. Respiratory Drive in Critically Ill Patients. Pathophysiology and Clinical Implications. Am J Respir Crit Care Med. 2020 Jan 1;201(1):20-32. doi: 10.1164/rccm.201903-0596SO.
PubMed 31437406Gattinoni L, Chiumello D, Caironi P, Busana M, Romitti F, Brazzi L, Camporota L. COVID-19 pneumonia: different respiratory treatments for different phenotypes? Intensive Care Med. 2020 Jun;46(6):1099-1102. doi: 10.1007/s00134-020-06033-2. Epub 2020 Apr 14. No abstract available.
PubMed 32291463Giosa L, Collins PD, Sciolla M, Cerrone F, Di Blasi S, Macri MM, Davicco L, Laguzzi A, Gorgonzola F, Penso R, Steinberg I, Muraccini M, Perboni A, Russotto V, Camporota L, Bellani G, Caironi P. Effects of CPAP and FiO2 on respiratory effort and lung stress in early COVID-19 pneumonia: a randomized, crossover study. Ann Intensive Care. 2023 Oct 17;13(1):103. doi: 10.1186/s13613-023-01202-0.
PubMed 37847454
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Transpulmonary Pressure in Covid-19 Pneumonia: Effects of Positive Pressure, Inspired Oxygen Fraction and Decubitus
- ClinicalTrials.gov ID
- NCT04885517
- Acronym / sponsor ID
- 2782
- Conditions
- COVID-19 Pneumonia
- Keywords
- COVID-19 Pneumonia, Esophageal Pressure, Respiratory Drive
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- San Luigi Gonzaga HospitalUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Aug 2021 (estimated)
- Study completion
- 1 Aug 2021 (estimated)
- First posted
- 13 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Spontaneous breathing, Venturi Mask FiO2 0.5, seated decubitus | Experimental | Device: Esophageal catheterPatient 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. |
| Spontaneous breathing, Non Rebreathing Mask, seated decubitus | Experimental | Device: Esophageal catheterPatient 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. |
| Continuous Positive Airway Pressure (CPAP) 7 cmH2O, FiO2 0.5, seated decubitus | Experimental | Device: Esophageal catheterPatient 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. |
| Continuous Positive Airway Pressure (CPAP) 7 cmH2O, FiO2 0.5, supine decubitus | Experimental | Device: Esophageal catheterPatient 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. |
| Continuous Positive Airway Pressure (CPAP) 7 cmH2O, FiO2 0.5, prone decubitus | Experimental | Device: Esophageal catheterPatient 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. |
| Continuous Positive Airway Pressure (CPAP) 7 cmH2O, FiO2 1, seated decubitus | Experimental | Device: Esophageal catheterPatient 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. |
| Continuous Positive Airway Pressure (CPAP) 12 cmH2O, FiO2 0.5, seated decubitus | Experimental | Device: Esophageal catheterPatient 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. |
| Continuous Positive Airway Pressure (CPAP) 12 cmH2O, FiO2 1, seated decubitus | Experimental | Device: Esophageal catheterPatient 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Esophageal catheterPatients are equipped with an esophageal catheter: positioning is performed after accurate nasopharyngeal anesthesia with lidocaine | Device | Continuous Positive Airway Pressure (CPAP) 12 cmH2O, FiO2 0.5, seated decubitus, Continuous Positive Airway Pressure (CPAP) 12 cmH2O, FiO2 1, seated decubitus, Continuous Positive Airway Pressure (CPAP) 7 cmH2O, FiO2 0.5, prone decubitus, Continuous Positive Airway Pressure (CPAP) 7 cmH2O, FiO2 0.5, seated decubitus, Continuous Positive Airway Pressure (CPAP) 7 cmH2O, FiO2 0.5, supine decubitus, Continuous Positive Airway Pressure (CPAP) 7 cmH2O, FiO2 1, seated decubitus, Spontaneous breathing, Non Rebreathing Mask, seated decubitus, Spontaneous breathing, Venturi Mask FiO2 0.5, seated decubitus |
Primary outcome
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)
2 secondary outcomes
Esophageal pressure swings at different levels of inspired oxygen fraction
Time frame: 160 minutes
Esophageal pressure swings at different decubiti
Time frame: 160 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2021.
- Results publication: PubMed 32228035Gattinoni L, Coppola S, Cressoni M, Busana M, Rossi S, Chiumello D. COVID-19 Does Not Lead to a "Typical" Acute Respiratory Distress Syndrome. Am J Respir Crit Care Med. 2020 May 15;201(10):1299-1300. doi: 10.1164/rccm.202003-0817LE. No abstract available.
- Results publication: PubMed 32355007Couzin-Frankel J. The mystery of the pandemic's 'happy hypoxia'. Science. 2020 May 1;368(6490):455-456. doi: 10.1126/science.368.6490.455. No abstract available.
- Results publication: PubMed 32747395Aliberti S, Radovanovic D, Billi F, Sotgiu G, Costanzo M, Pilocane T, Saderi L, Gramegna A, Rovellini A, Perotto L, Monzani V, Santus P, Blasi F. Helmet CPAP treatment in patients with COVID-19 pneumonia: a multicentre cohort study. Eur Respir J. 2020 Oct 15;56(4):2001935. doi: 10.1183/13993003.01935-2020. Print 2020 Oct.
- Results publication: PubMed 32412581Elharrar X, Trigui Y, Dols AM, Touchon F, Martinez S, Prud'homme E, Papazian L. Use of Prone Positioning in Nonintubated Patients With COVID-19 and Hypoxemic Acute Respiratory Failure. JAMA. 2020 Jun 9;323(22):2336-2338. doi: 10.1001/jama.2020.8255.
- Results publication: PubMed 33089348Chiumello D, Busana M, Coppola S, Romitti F, Formenti P, Bonifazi M, Pozzi T, Palumbo MM, Cressoni M, Herrmann P, Meissner K, Quintel M, Camporota L, Marini JJ, Gattinoni L. Physiological and quantitative CT-scan characterization of COVID-19 and typical ARDS: a matched cohort study. Intensive Care Med. 2020 Dec;46(12):2187-2196. doi: 10.1007/s00134-020-06281-2. Epub 2020 Oct 21.
- Results publication: PubMed 32329799Marini JJ, Gattinoni L. Management of COVID-19 Respiratory Distress. JAMA. 2020 Jun 9;323(22):2329-2330. doi: 10.1001/jama.2020.6825. No abstract available.
- Results publication: PubMed 32215647Poston JT, Patel BK, Davis AM. Management of Critically Ill Adults With COVID-19. JAMA. 2020 May 12;323(18):1839-1841. doi: 10.1001/jama.2020.4914. No abstract available.
- Results publication: PubMed 31274034Gattinoni L, Giosa L, Bonifazi M, Pasticci I, Busana M, Macri M, Romitti F, Vassalli F, Quintel M. Targeting transpulmonary pressure to prevent ventilator-induced lung injury. Expert Rev Respir Med. 2019 Aug;13(8):737-746. doi: 10.1080/17476348.2019.1638767. Epub 2019 Jul 5.
- Results publication: PubMed 27626833Brochard L, Slutsky A, Pesenti A. Mechanical Ventilation to Minimize Progression of Lung Injury in Acute Respiratory Failure. Am J Respir Crit Care Med. 2017 Feb 15;195(4):438-442. doi: 10.1164/rccm.201605-1081CP.
- Results publication: PubMed 32325004Tonelli R, Fantini R, Tabbi L, Castaniere I, Pisani L, Pellegrino MR, Della Casa G, D'Amico R, Girardis M, Nava S, Clini EM, Marchioni A. Early Inspiratory Effort Assessment by Esophageal Manometry Predicts Noninvasive Ventilation Outcome in De Novo Respiratory Failure. A Pilot Study. Am J Respir Crit Care Med. 2020 Aug 15;202(4):558-567. doi: 10.1164/rccm.201912-2512OC.
- Results publication: PubMed 33140181Goligher EC, Jonkman AH, Dianti J, Vaporidi K, Beitler JR, Patel BK, Yoshida T, Jaber S, Dres M, Mauri T, Bellani G, Demoule A, Brochard L, Heunks L. Clinical strategies for implementing lung and diaphragm-protective ventilation: avoiding insufficient and excessive effort. Intensive Care Med. 2020 Dec;46(12):2314-2326. doi: 10.1007/s00134-020-06288-9. Epub 2020 Nov 2.
- Results publication: PubMed 32736637Apigo M, Schechtman J, Dhliwayo N, Al Tameemi M, Gazmuri RJ. Development of a work of breathing scale and monitoring need of intubation in COVID-19 pneumonia. Crit Care. 2020 Jul 31;24(1):477. doi: 10.1186/s13054-020-03176-y. No abstract available.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pietro Caironi, MD principal investigator
San Luigi Gonzaga Hospital
Lorenzo Giosa, MD principal investigator
San Luigi Gonzaga Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Esophageal catheter in people with COVID-19 Pneumonia, run by San Luigi Gonzaga Hospital at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pietro Caironi, Pr (+390119026386, pietro.caironi@unito.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Esophageal pressure swings at different levels of positive end-expiratory pressure (PEEP) (time frame: 160 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04885517, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2021.