Covid19NCT04486729
Respiratory Mechanics and Gas Exchange Characteristics in Patient With SARS-CoV-2
An observational study of Covid19 and ARDS, Human, run by Sanatorio Anchorena San Martin at 1 site in Argentina.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, ARDS, Human
- What is being tested?
- High PEEP with end inspiratory pause, Low PEEP - FiO2 high and High PEEP without end inspiratory pause
- How many people
- 15 participants
- Where
- 1 siteArgentina
- Study dates
- 1 Jul 2020to 20 Oct 2020
- Phase
- Observational
- 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
Study population: Patients with ARDS secondary to COVID-19 under invasive mechanical ventilation
Who may be able to join
- 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
Who cannot join
- RASS target higher than -5
- COPD diagnosis
- Pneumothorax
- Intracraneal Hypertension
- Pregnancy
- Cardiac inssuficiency uncompensated
Show all 9Show fewer
- Chest wall deformity
- Bronchopleural fistula
- Contraindication to use esophageal manometry
Trial locations and contacts
1 site in 1 country.
Argentina1 site, 1 recruiting
- Recruiting
Sanatorio Anchorena San Martin
San Martín, Buenos Aires
Javier H Dorado, PT, (054) 1141644262, javierhdorado@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Covid19, ARDS, Human
- Being tested
- High PEEP with end inspiratory pause, Low PEEP - FiO2 high, High PEEP without end inspiratory pause, Low PEEP - FiO2 low
- Medical subject headings
- COVID-19, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High PEEP with end inspiratory pauseOther
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
Low PEEP - FiO2 highOther
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%
High PEEP without end inspiratory pauseOther
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
Low PEEP - FiO2 lowOther
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%
What is being measured
The primary outcome is the main question the study is designed to answer.
Driving transpulmonary pressure (cmH2O)
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).
Measured: 10 minutes
Bohr dead space fraction (%)
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
Measured: 10 minutes
Shunt fraction (%)
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)
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2020
- Study start1 Jul 2020
- Primary completion10 Oct 2020 (estimated)
- Study completion20 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanatorio Anchorena San Martin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matias Accoce, Sanatorio Anchorena San Martin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04486729
- Sponsor's protocol ID
- 10.2020
- Status last verified
- Jul 2020
- First submitted
- 21 Jul 2020
- Last updated
- 27 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Guo T, Fan Y, Chen M, Wu X, Zhang L, He T, Wang H, Wan J, Wang X, Lu Z. Cardiovascular Implications of Fatal Outcomes of Patients With Coronavirus Disease 2019 (COVID-19). JAMA Cardiol. 2020 Jul 1;5(7):811-818. doi: 10.1001/jamacardio.2020.1017.
PubMed 32219356Ziehr DR, Alladina J, Petri CR, Maley JH, Moskowitz A, Medoff BD, Hibbert KA, Thompson BT, Hardin CC. Respiratory Pathophysiology of Mechanically Ventilated Patients with COVID-19: A Cohort Study. Am J Respir Crit Care Med. 2020 Jun 15;201(12):1560-1564. doi: 10.1164/rccm.202004-1163LE. No abstract available.
PubMed 32348678ARDS Definition Task Force; Ranieri VM, Rubenfeld GD, Thompson BT, Ferguson ND, Caldwell E, Fan E, Camporota L, Slutsky AS. Acute respiratory distress syndrome: the Berlin Definition. JAMA. 2012 Jun 20;307(23):2526-33. doi: 10.1001/jama.2012.5669.
PubMed 22797452Gattinoni 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 32291463Chen L, Del Sorbo L, Grieco DL, Junhasavasdikul D, Rittayamai N, Soliman I, Sklar MC, Rauseo M, Ferguson ND, Fan E, Richard JM, Brochard L. Potential for Lung Recruitment Estimated by the Recruitment-to-Inflation Ratio in Acute Respiratory Distress Syndrome. A Clinical Trial. Am J Respir Crit Care Med. 2020 Jan 15;201(2):178-187. doi: 10.1164/rccm.201902-0334OC.
PubMed 31577153Tusman G, Gogniat E, Madorno M, Otero P, Dianti J, Ceballos IF, Ceballos M, Verdier N, Bohm SH, Rodriguez PO, San Roman E. Effect of PEEP on Dead Space in an Experimental Model of ARDS. Respir Care. 2020 Jan;65(1):11-20. doi: 10.4187/respcare.06843. Epub 2019 Oct 15.
PubMed 31615922Aguirre-Bermeo H, Moran I, Bottiroli M, Italiano S, Parrilla FJ, Plazolles E, Roche-Campo F, Mancebo J. End-inspiratory pause prolongation in acute respiratory distress syndrome patients: effects on gas exchange and mechanics. Ann Intensive Care. 2016 Dec;6(1):81. doi: 10.1186/s13613-016-0183-z. Epub 2016 Aug 24.
PubMed 27558174Santos C, Ferrer M, Roca J, Torres A, Hernandez C, Rodriguez-Roisin R. Pulmonary gas exchange response to oxygen breathing in acute lung injury. Am J Respir Crit Care Med. 2000 Jan;161(1):26-31. doi: 10.1164/ajrccm.161.1.9902084.
PubMed 10619793Pan C, Chen L, Lu C, Zhang W, Xia JA, Sklar MC, Du B, Brochard L, Qiu H. Lung Recruitability in COVID-19-associated Acute Respiratory Distress Syndrome: A Single-Center Observational Study. Am J Respir Crit Care Med. 2020 May 15;201(10):1294-1297. doi: 10.1164/rccm.202003-0527LE. No abstract available.
PubMed 32200645Chen L, Del Sorbo L, Grieco DL, Shklar O, Junhasavasdikul D, Telias I, Fan E, Brochard L. Airway Closure in Acute Respiratory Distress Syndrome: An Underestimated and Misinterpreted Phenomenon. Am J Respir Crit Care Med. 2018 Jan 1;197(1):132-136. doi: 10.1164/rccm.201702-0388LE. No abstract available.
PubMed 28557528Tobin MJ. Basing Respiratory Management of COVID-19 on Physiological Principles. Am J Respir Crit Care Med. 2020 Jun 1;201(11):1319-1320. doi: 10.1164/rccm.202004-1076ED. No abstract available.
PubMed 32281885Talmor D, Sarge T, Malhotra A, O'Donnell CR, Ritz R, Lisbon A, Novack V, Loring SH. Mechanical ventilation guided by esophageal pressure in acute lung injury. N Engl J Med. 2008 Nov 13;359(20):2095-104. doi: 10.1056/NEJMoa0708638. Epub 2008 Nov 11.
PubMed 19001507Yoshida T, Amato MBP, Grieco DL, Chen L, Lima CAS, Roldan R, Morais CCA, Gomes S, Costa ELV, Cardoso PFG, Charbonney E, Richard JM, Brochard L, Kavanagh BP. Esophageal Manometry and Regional Transpulmonary Pressure in Lung Injury. Am J Respir Crit Care Med. 2018 Apr 15;197(8):1018-1026. doi: 10.1164/rccm.201709-1806OC.
PubMed 29323931Tahvanainen J, Meretoja O, Nikki P. Can central venous blood replace mixed venous blood samples? Crit Care Med. 1982 Nov;10(11):758-61. doi: 10.1097/00003246-198211000-00012.
PubMed 7140317Monnet X, Teboul JL. Passive leg raising: five rules, not a drop of fluid! Crit Care. 2015 Jan 14;19(1):18. doi: 10.1186/s13054-014-0708-5. No abstract available.
PubMed 25658678
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory System Mechanics and Gas Exchange Characteristics Applying Different Ventilatory Strategies in Patients With SARS-CoV-2
- ClinicalTrials.gov ID
- NCT04486729
- Acronym / sponsor ID
- 10.2020
- Conditions
- Covid19, ARDS, Human
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Sanatorio Anchorena San MartinUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 10 Oct 2020 (estimated)
- Study completion
- 20 Oct 2020 (estimated)
- First posted
- 27 Jul 2020 (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 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.
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 design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with ARDS secondary to COVID-19 under invasive mechanical ventilation
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- RASS target higher than -5
- COPD diagnosis
- Pneumothorax
- Intracraneal Hypertension
- Pregnancy
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 |
|---|---|---|
| High PEEP with end inspiratory pauseApplying 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 highApplying 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 pauseApplying 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 lowApplying 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% | Other | – |
Primary outcome
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2020.
- Background: PubMed 32219356Guo T, Fan Y, Chen M, Wu X, Zhang L, He T, Wang H, Wan J, Wang X, Lu Z. Cardiovascular Implications of Fatal Outcomes of Patients With Coronavirus Disease 2019 (COVID-19). JAMA Cardiol. 2020 Jul 1;5(7):811-818. doi: 10.1001/jamacardio.2020.1017.
- Background: PubMed 32348678Ziehr DR, Alladina J, Petri CR, Maley JH, Moskowitz A, Medoff BD, Hibbert KA, Thompson BT, Hardin CC. Respiratory Pathophysiology of Mechanically Ventilated Patients with COVID-19: A Cohort Study. Am J Respir Crit Care Med. 2020 Jun 15;201(12):1560-1564. doi: 10.1164/rccm.202004-1163LE. No abstract available.
- Background: PubMed 22797452ARDS Definition Task Force; Ranieri VM, Rubenfeld GD, Thompson BT, Ferguson ND, Caldwell E, Fan E, Camporota L, Slutsky AS. Acute respiratory distress syndrome: the Berlin Definition. JAMA. 2012 Jun 20;307(23):2526-33. doi: 10.1001/jama.2012.5669.
- Background: PubMed 32291463Gattinoni 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.
- Background: PubMed 31577153Chen L, Del Sorbo L, Grieco DL, Junhasavasdikul D, Rittayamai N, Soliman I, Sklar MC, Rauseo M, Ferguson ND, Fan E, Richard JM, Brochard L. Potential for Lung Recruitment Estimated by the Recruitment-to-Inflation Ratio in Acute Respiratory Distress Syndrome. A Clinical Trial. Am J Respir Crit Care Med. 2020 Jan 15;201(2):178-187. doi: 10.1164/rccm.201902-0334OC.
- Background: PubMed 31615922Tusman G, Gogniat E, Madorno M, Otero P, Dianti J, Ceballos IF, Ceballos M, Verdier N, Bohm SH, Rodriguez PO, San Roman E. Effect of PEEP on Dead Space in an Experimental Model of ARDS. Respir Care. 2020 Jan;65(1):11-20. doi: 10.4187/respcare.06843. Epub 2019 Oct 15.
- Background: PubMed 27558174Aguirre-Bermeo H, Moran I, Bottiroli M, Italiano S, Parrilla FJ, Plazolles E, Roche-Campo F, Mancebo J. End-inspiratory pause prolongation in acute respiratory distress syndrome patients: effects on gas exchange and mechanics. Ann Intensive Care. 2016 Dec;6(1):81. doi: 10.1186/s13613-016-0183-z. Epub 2016 Aug 24.
- Background: PubMed 10619793Santos C, Ferrer M, Roca J, Torres A, Hernandez C, Rodriguez-Roisin R. Pulmonary gas exchange response to oxygen breathing in acute lung injury. Am J Respir Crit Care Med. 2000 Jan;161(1):26-31. doi: 10.1164/ajrccm.161.1.9902084.
- Background: PubMed 32200645Pan C, Chen L, Lu C, Zhang W, Xia JA, Sklar MC, Du B, Brochard L, Qiu H. Lung Recruitability in COVID-19-associated Acute Respiratory Distress Syndrome: A Single-Center Observational Study. Am J Respir Crit Care Med. 2020 May 15;201(10):1294-1297. doi: 10.1164/rccm.202003-0527LE. No abstract available.
- Background: PubMed 28557528Chen L, Del Sorbo L, Grieco DL, Shklar O, Junhasavasdikul D, Telias I, Fan E, Brochard L. Airway Closure in Acute Respiratory Distress Syndrome: An Underestimated and Misinterpreted Phenomenon. Am J Respir Crit Care Med. 2018 Jan 1;197(1):132-136. doi: 10.1164/rccm.201702-0388LE. No abstract available.
- Background: PubMed 32281885Tobin MJ. Basing Respiratory Management of COVID-19 on Physiological Principles. Am J Respir Crit Care Med. 2020 Jun 1;201(11):1319-1320. doi: 10.1164/rccm.202004-1076ED. No abstract available.
- Background: PubMed 19001507Talmor D, Sarge T, Malhotra A, O'Donnell CR, Ritz R, Lisbon A, Novack V, Loring SH. Mechanical ventilation guided by esophageal pressure in acute lung injury. N Engl J Med. 2008 Nov 13;359(20):2095-104. doi: 10.1056/NEJMoa0708638. Epub 2008 Nov 11.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and ARDS, Human, run by Sanatorio Anchorena San Martin at 1 site in Argentina.
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 8 inclusion and 9 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 27 Jul 2020. 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 Argentina. 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 Javier H Dorado, PT ((054) 114164 4262, javierhdorado@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Driving transpulmonary pressure (cmH2O) (time frame: 10 minutes). The study lists 3 primary outcomes in all. 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 NCT04486729, which also lists 18 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 27 Jul 2020.