Acute Respiratory Distress Syndrome (ARDS)COVIDPTcareNCT05024500
Clinical and Functional Outcomes of Critically Ill Patients With COVID-19
A study testing ARDSNet table, Driving Pressure and Electrical Impedance Tomography in people with Acute Respiratory Distress Syndrome (ARDS), run by University of Pernambuco at 4 sites in Brazil.
Trial summary
People affected by Severe Acute Respiratory Syndrome (SARS) by COVID-19 virus my require a long lasting invasive mechanical ventilation life support. To prevent damages to the lungs a number of protective lung ventilation measures are taken, one of them encounters the positive end expiratory pressure (PEEP) titration. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome (ARDS)
- What is being tested?
- ARDSNet table, Driving Pressure and Electrical Impedance Tomography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 4 sitesBrazil
- Study dates
- 21 Oct 2020to 30 Dec 2022
- 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
- mechanically ventilated patients due to acute respiratory failure associated to COVID-19 confirmed or suspected cases
Who cannot join
- consent refusal by patient, family or doctor
Trial locations and contacts
4 sites in 1 country.
Brazil4 sites
Hospital das Clinicas - UFPE
Recife, Pernambuco, 50670-901
Physical Therapy Department, Universidade Federal de Pernambuco
Recife, Pernambuco, 50670-901
Hospital da Mulher do Recife
Recife, Pernambuco, 50790-640
Hospital Geral Otavio de Freitas
Recife, Pernambuco, 50920-460
About this study
Official title: Clinical, Respiratory, Peripheral, Muscle and Functionality Outcomes of Adult ICU Inpatients and Rehabilitation-center Outpatients With COVID-19
People affected by Severe Acute Respiratory Syndrome (SARS) by COVID-19 virus my require a long lasting invasive mechanical ventilation life support. To prevent damages to the lungs a number of protective lung ventilation measures are taken, one of them encounters the positive end expiratory pressure (PEEP) titration. Up to date, it is unclear the best method to titrate PEEP considering this unconventional syndrome compared to other etiologies. In addition to the long lasting advanced life support and bedridden condition, other factors may affect respiratory and peripheral muscle function of these patients. Therefore, the investigators intend to follow up these patients randomized to one of the three-arm experimental PEEP titration and after ICU discharge their status on clinical, laboratory and physical functions assessments.
Read the detailed description
Introduction: Coronavirus Disease 2019 (COVID-19), caused by Severe Acute Respiratory Syndrome - Coronavirus-2 (SARS-CoV-2) requires mechanical ventilatory (MV) life support. In this scenario, lung protective strategies have been recommended for avoiding ventilator induced lung injuries mainly by inappropriate positive end expiratory pressure (PEEP) titration. However, the best method of PEEP titration for these patients remains unclear, since its clinical and morphofunctional phenotype may differ from the conventional acute respiratory distress syndrome (ARDS) phenotype resulted from other etiologies. In addition, these patients' condition of long lasting MV dependency and bed restriction may lead to deterioration of respiratory and peripheral muscles functions.
Objective: To compare the clinical and laboratory evolution and the respiratory and peripheral muscle functions in mechanically ventilated patients with COVID-19 submitted to PEEP titration by the following methods: ARDSNet protocol, driving pressure (DP) and electrical impedance tomography (EIT), as well as following them up after hospital discharge.
Methods: This is a controlled, randomized, double blind clinical trial with 90 mechanically ventilated patients to be randomized in one of the 3 PEEP titration- related groups: ARDSNet protocol, Driving Pressure-DP (electing PEEP level by the lowest DP) and by the EIT (PEEP selected will be the closest level above the intercept point of cumulated collapse and overdistension percentage curves). Clinical, laboratory, oxygenation, ventilation, respiratory and regional mechanics data, as well as peripheral muscle outcomes (strength and functionality) will be monitored from intubation to extubation in the supine and prone position. The outcomes of respiratory and peripheral muscles functionality will be monitored for six months after hospital discharge. All ethical principles will be respected with either written Free and Consent Term by the patient or relatives at the intensive care phase or at the post ICU discharge phase. Data will be registered for posterior analysis, which considers the difference between groups with p <0.05.
Expected results: Based on this study, it is expected to identify the Peep titration method associated to the greater beneficial and less deleterious effects in critically ill patients on MV. Also to address appropriate lung protective ventilation strategy for these patients and to detect respiratory and peripheral muscle disorders as early as possible in critically ill survivors.
- Being tested
- ARDSNet table, Driving Pressure, Electrical Impedance Tomography
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARDSNet tableOther
The setting of the lowest PEEP level and FiO2 match stated by the table to achieve a goal oxygenation.
Driving PressureOther
The setting of the lowest PEEP level by the lowest correspondent driving pressure, which is defined by the difference of plateau pressure, after a modified alveolar recruitment maneuver.
Electrical Impedance TomographyOther
The setting of the PEEP level above the intersection of the curves representing relative alveolar overdistention and collapse, after a modified alveolar recruitment maneuver.
| Study group | Role | What they receive |
|---|---|---|
| ADRSNet protocol | Experimental | ARDSnet protocol is the current, standard of care for ARDS. Its used by setting PEEP and the fraction of inspired oxygen (FiO2) to achieve the oxygenation goal (SpO2 ≥ 93% - accepting the range of 90-96%) Receives: Other: ARDSNet table |
| Driving Pressure (DP) | Experimental | setting PEEP after performing a modified alveolar recruitment maneuver followed by a decremental PEEP titration electing the level correspondent to the lowest driving pressure. Receives: Other: Driving Pressure |
| Electrical Impedance Tomography (EIT) | Experimental | After performing a modified alveolar recruitment maneuver, the PEEP decremental titration guided by the EIT will be set at the level above the intersection of the curves representing relative alveolar overdistention and collapse. Receives: Other: Electrical Impedance Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Murray Score (LIS)
Scoring system for lung injury including hypoxemia, respiratory system compliance, chest radiographic findings and level of PEEP. The minimum value is zero and the maximum value is sixteen. The higher the score the worse outcome.
Measured: 4 hours
Potential lung recruitment measured during electrical impedance tomography
to quantify lung ventilation distribution
Measured: 4 hours
Secondary outcomes (16)
Length of days in intensive care unit (ICU days)
to quantify the number of days spent in a critical care unit
Measured: Through study completion, an average of 1 year
Work of breathing (WOB) measured during surface electromyography
measured in root-mean-squared electromyography signals
Measured: 4 hours
Duration of mechanical ventilation (MV days)
to quantity the number of days with use of invasive mechanical ventilation in inpatients.
Measured: Through study completion, an average of 1 year
ICU Mortality
to quantify number of living days between ICU admission and deceased status
Measured: Through study completion, an average of 1 year
respiratory muscle strength
maximal static respiratory mouth pressures
Measured: Through study completion, an average of 1 year
Forced vital capacity (FVC) measured during spirometry
measures obtained by spirometry in outpatients
Measured: Through study completion, an average of 1 year
diaphragmatic mobility measured during ultrasonography
diaphragmatic excursion expressed in millimeters
Measured: Through study completion, an average of 1 year
diaphragmatic thickening measured during ultrasonography
diaphragmatic thickening expressed in millimeters
Measured: Through study completion, an average of 1 year
breathing pattern measured during airway flowmeter
a device to quantify airway flow
Measured: Through study completion, an average of 1 year
peripheral muscle strength I
to be evaluated by Medical Research Council's scale. The minimum score is 0 and the maximum is 60. The higher the score, the better outcome.
Measured: Through study completion, an average of 1 year
peripheral muscle strength II
to be evaluated by a handgrip dynamometers in outpatients
Measured: Through study completion, an average of 1 year
peripheral muscle strength III
to be evaluated by a handheld dynamometer in outpatients
Measured: Through study completion, an average of 1 year
six-minute walk test (6WT)
sub-maximal exercise test used to assess aerobic capacity and endurance in outpatients
Measured: Through study completion, an average of 1 year
functional capacity (Perme scale)
The minimum score is 0 and the maximum is 32. The higher the score, the better outcome.
Measured: Through study completion, an average of 1 year
daily activities performance
to be evaluated by Barthel Index in outpatients
Measured: Through study completion, an average of 1 year
quality of life measured by Short Form Health survey 36
score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2021
- Study start21 Oct 2020
- Primary completion11 Jul 2021
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory Distress Syndrome (ARDS)Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- three groups of treatments (A, B and C) are given so that one group receives only A while another group receives only B and the third group receives only C. All volunteers will be randomized to one of the three groups of treatment.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pernambuco
- Sponsor type
- University, hospital or other
- Collaborators
- Universidade Federal de Pernambuco, Coordination for the Improvement of Higher Education Personnel, Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação de Amparo à Ciência e Tecnologia de Pernambuco
- Responsible party
- Principal investigator, Shirley Lima Campos, Universidade Federal de Pernambuco
- Investigators
- Shirley Lima Campos, PhD, Study director, Universidade Federal de Pernambuco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05024500
- Sponsor's protocol ID
- COVIDPTcare
- Acronym
- COVIDPTcare
- Status last verified
- Mar 2023
- First submitted
- 18 Dec 2020
- Last updated
- 7 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: * participant characteristics (age, gender) * clinical measurements (blood pressure, heart rate) * medical history * clinical laboratory results * images (X-rays) * adverse events (hemodynamic and respiratory instability, interruptions) * details of randomisation and treatment received
Publications
Adhikari SP, Meng S, Wu YJ, Mao YP, Ye RX, Wang QZ, Sun C, Sylvia S, Rozelle S, Raat H, Zhou H. Epidemiology, causes, clinical manifestation and diagnosis, prevention and control of coronavirus disease (COVID-19) during the early outbreak period: a scoping review. Infect Dis Poverty. 2020 Mar 17;9(1):29. doi: 10.1186/s40249-020-00646-x.
PubMed 32183901Adler A, Arnold JH, Bayford R, Borsic A, Brown B, Dixon P, Faes TJ, Frerichs I, Gagnon H, Garber Y, Grychtol B, Hahn G, Lionheart WR, Malik A, Patterson RP, Stocks J, Tizzard A, Weiler N, Wolf GK. GREIT: a unified approach to 2D linear EIT reconstruction of lung images. Physiol Meas. 2009 Jun;30(6):S35-55. doi: 10.1088/0967-3334/30/6/S03. Epub 2009 Jun 2.
PubMed 19491438Beitler JR, Sarge T, Banner-Goodspeed VM, Gong MN, Cook D, Novack V, Loring SH, Talmor D; EPVent-2 Study Group. Effect of Titrating Positive End-Expiratory Pressure (PEEP) With an Esophageal Pressure-Guided Strategy vs an Empirical High PEEP-Fio2 Strategy on Death and Days Free From Mechanical Ventilation Among Patients With Acute Respiratory Distress Syndrome: A Randomized Clinical Trial. JAMA. 2019 Mar 5;321(9):846-857. doi: 10.1001/jama.2019.0555.
PubMed 30776290Costa EL, Borges JB, Melo A, Suarez-Sipmann F, Toufen C Jr, Bohm SH, Amato MB. Bedside estimation of recruitable alveolar collapse and hyperdistension by electrical impedance tomography. Intensive Care Med. 2009 Jun;35(6):1132-7. doi: 10.1007/s00134-009-1447-y. Epub 2009 Mar 3.
PubMed 19255741Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11.
PubMed 32171076Frerichs I, Becher T, Weiler N. Electrical impedance tomography imaging of the cardiopulmonary system. Curr Opin Crit Care. 2014 Jun;20(3):323-32. doi: 10.1097/MCC.0000000000000088.
PubMed 24739268Fumagalli J, Berra L. What does the Acute Respiratory Distress Syndrome trial (ART) teach us?-it is time for precision medicine and precision trials in critical care! J Thorac Dis. 2018 Mar;10(3):1300-1303. doi: 10.21037/jtd.2018.03.31. No abstract available.
PubMed 29707281Goh KJ, Choong MC, Cheong EH, Kalimuddin S, Duu Wen S, Phua GC, Chan KS, Haja Mohideen S. Rapid Progression to Acute Respiratory Distress Syndrome: Review of Current Understanding of Critical Illness from Coronavirus Disease 2019 (COVID-19) Infection. Ann Acad Med Singap. 2020 Mar 16;49(3):108-118.
PubMed 32200400Huh JW, Jung H, Choi HS, Hong SB, Lim CM, Koh Y. Efficacy of positive end-expiratory pressure titration after the alveolar recruitment manoeuvre in patients with acute respiratory distress syndrome. Crit Care. 2009;13(1):R22. doi: 10.1186/cc7725. Epub 2009 Feb 24.
PubMed 19239703Liu S, Tan L, Moller K, Frerichs I, Yu T, Liu L, Huang Y, Guo F, Xu J, Yang Y, Qiu H, Zhao Z. Identification of regional overdistension, recruitment and cyclic alveolar collapse with electrical impedance tomography in an experimental ARDS model. Crit Care. 2016 May 3;20(1):119. doi: 10.1186/s13054-016-1300-y.
PubMed 27142073Murray JF, Matthay MA, Luce JM, Flick MR. An expanded definition of the adult respiratory distress syndrome. Am Rev Respir Dis. 1988 Sep;138(3):720-3. doi: 10.1164/ajrccm/138.3.720. No abstract available.
PubMed 3202424Sahetya SK, Hager DN, Stephens RS, Needham DM, Brower RG. PEEP Titration to Minimize Driving Pressure in Subjects With ARDS: A Prospective Physiological Study. Respir Care. 2020 May;65(5):583-589. doi: 10.4187/respcare.07102. Epub 2019 Nov 26.
PubMed 31772068Thomas P, Baldwin C, Bissett B, Boden I, Gosselink R, Granger CL, Hodgson C, Jones AY, Kho ME, Moses R, Ntoumenopoulos G, Parry SM, Patman S, van der Lee L. Physiotherapy management for COVID-19 in the acute hospital setting: clinical practice recommendations. J Physiother. 2020 Apr;66(2):73-82. doi: 10.1016/j.jphys.2020.03.011. Epub 2020 Mar 30.
PubMed 32312646Zheng YY, Ma YT, Zhang JY, Xie X. COVID-19 and the cardiovascular system. Nat Rev Cardiol. 2020 May;17(5):259-260. doi: 10.1038/s41569-020-0360-5.
PubMed 32139904Silveira LTYD, Silva JMD, Tanaka C, Fu C. Decline in functional status after intensive care unit discharge is associated with ICU readmission: a prospective cohort study. Physiotherapy. 2019 Sep;105(3):321-327. doi: 10.1016/j.physio.2018.07.010. Epub 2018 Aug 2.
PubMed 30342701
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical, Respiratory, Peripheral, Muscle and Functionality Outcomes of Adult ICU Inpatients and Rehabilitation-center Outpatients With COVID-19
- ClinicalTrials.gov ID
- NCT05024500
- Acronym / sponsor ID
- COVIDPTcare / COVIDPTcare
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University of PernambucoUniversity, hospital or other
- Collaborators
- Universidade Federal de Pernambuco, Coordination for the Improvement of Higher Education Personnel, Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação de Amparo à Ciência e Tecnologia de Pernambuco
- Study start
- 21 Oct 2020 (actual)
- Primary completion
- 11 Jul 2021 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 27 Aug 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.
People affected by Severe Acute Respiratory Syndrome (SARS) by COVID-19 virus my require a long lasting invasive mechanical ventilation life support. To prevent damages to the lungs a number of protective lung ventilation measures are taken, one of them encounters the positive end expiratory pressure (PEEP) titration. Up to date, it is unclear the best method to titrate PEEP considering this unconventional syndrome compared to other etiologies. In addition to the long lasting advanced life support and bedridden condition, other factors may affect respiratory and peripheral muscle function of these patients. Therefore, the investigators intend to follow up these patients randomized to one of the three-arm experimental PEEP titration and after ICU discharge their status on clinical, laboratory and physical functions assessments.
Detailed description
Introduction: Coronavirus Disease 2019 (COVID-19), caused by Severe Acute Respiratory Syndrome - Coronavirus-2 (SARS-CoV-2) requires mechanical ventilatory (MV) life support. In this scenario, lung protective strategies have been recommended for avoiding ventilator induced lung injuries mainly by inappropriate positive end expiratory pressure (PEEP) titration. However, the best method of PEEP titration for these patients remains unclear, since its clinical and morphofunctional phenotype may differ from the conventional acute respiratory distress syndrome (ARDS) phenotype resulted from other etiologies. In addition, these patients' condition of long lasting MV dependency and bed restriction may lead to deterioration of respiratory and peripheral muscles functions.
Objective: To compare the clinical and laboratory evolution and the respiratory and peripheral muscle functions in mechanically ventilated patients with COVID-19 submitted to PEEP titration by the following methods: ARDSNet protocol, driving pressure (DP) and electrical impedance tomography (EIT), as well as following them up after hospital discharge.
Methods: This is a controlled, randomized, double blind clinical trial with 90 mechanically ventilated patients to be randomized in one of the 3 PEEP titration- related groups: ARDSNet protocol, Driving Pressure-DP (electing PEEP level by the lowest DP) and by the EIT (PEEP selected will be the closest level above the intercept point of cumulated collapse and overdistension percentage curves). Clinical, laboratory, oxygenation, ventilation, respiratory and regional mechanics data, as well as peripheral muscle outcomes (strength and functionality) will be monitored from intubation to extubation in the supine and prone position. The outcomes of respiratory and peripheral muscles functionality will be monitored for six months after hospital discharge. All ethical principles will be respected with either written Free and Consent Term by the patient or relatives at the intensive care phase or at the post ICU discharge phase. Data will be registered for posterior analysis, which considers the difference between groups with p <0.05.
Expected results: Based on this study, it is expected to identify the Peep titration method associated to the greater beneficial and less deleterious effects in critically ill patients on MV. Also to address appropriate lung protective ventilation strategy for these patients and to detect respiratory and peripheral muscle disorders as early as possible in critically ill survivors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- three groups of treatments (A, B and C) are given so that one group receives only A while another group receives only B and the third group receives only C. All volunteers will be randomized to one of the three groups of treatment.
| Arm | Type | Receives |
|---|---|---|
| ADRSNet protocol | Experimental | Other: ARDSNet tableARDSnet protocol is the current, standard of care for ARDS. Its used by setting PEEP and the fraction of inspired oxygen (FiO2) to achieve the oxygenation goal (SpO2 ≥ 93% - accepting the range of 90-96%) |
| Driving Pressure (DP) | Experimental | Other: Driving Pressuresetting PEEP after performing a modified alveolar recruitment maneuver followed by a decremental PEEP titration electing the level correspondent to the lowest driving pressure. |
| Electrical Impedance Tomography (EIT) | Experimental | Other: Electrical Impedance TomographyAfter performing a modified alveolar recruitment maneuver, the PEEP decremental titration guided by the EIT will be set at the level above the intersection of the curves representing relative alveolar overdistention and collapse. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- mechanically ventilated patients due to acute respiratory failure associated to COVID-19 confirmed or suspected cases
Key exclusion criteria (1 listed)
- consent refusal by patient, family or doctor
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 |
|---|---|---|
| ARDSNet tableThe setting of the lowest PEEP level and FiO2 match stated by the table to achieve a goal oxygenation. | Other | ADRSNet protocol |
| Driving PressureThe setting of the lowest PEEP level by the lowest correspondent driving pressure, which is defined by the difference of plateau pressure, after a modified alveolar recruitment maneuver. | Other | Driving Pressure (DP) |
| Electrical Impedance TomographyThe setting of the PEEP level above the intersection of the curves representing relative alveolar overdistention and collapse, after a modified alveolar recruitment maneuver. | Other | Electrical Impedance Tomography (EIT) |
Primary outcome
Murray Score (LIS)
Time frame: 4 hours
Scoring system for lung injury including hypoxemia, respiratory system compliance, chest radiographic findings and level of PEEP. The minimum value is zero and the maximum value is sixteen. The higher the score the worse outcome.
Potential lung recruitment measured during electrical impedance tomography
Time frame: 4 hours
to quantify lung ventilation distribution
16 secondary outcomes
Length of days in intensive care unit (ICU days)
Time frame: Through study completion, an average of 1 year
Work of breathing (WOB) measured during surface electromyography
Time frame: 4 hours
Duration of mechanical ventilation (MV days)
Time frame: Through study completion, an average of 1 year
ICU Mortality
Time frame: Through study completion, an average of 1 year
respiratory muscle strength
Time frame: Through study completion, an average of 1 year
Forced vital capacity (FVC) measured during spirometry
Time frame: Through study completion, an average of 1 year
diaphragmatic mobility measured during ultrasonography
Time frame: Through study completion, an average of 1 year
diaphragmatic thickening measured during ultrasonography
Time frame: Through study completion, an average of 1 year
breathing pattern measured during airway flowmeter
Time frame: Through study completion, an average of 1 year
peripheral muscle strength I
Time frame: Through study completion, an average of 1 year
peripheral muscle strength II
Time frame: Through study completion, an average of 1 year
peripheral muscle strength III
Time frame: Through study completion, an average of 1 year
six-minute walk test (6WT)
Time frame: Through study completion, an average of 1 year
functional capacity (Perme scale)
Time frame: Through study completion, an average of 1 year
daily activities performance
Time frame: Through study completion, an average of 1 year
quality of life measured by Short Form Health survey 36
Time frame: Through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2023.
- Background: PubMed 32183901Adhikari SP, Meng S, Wu YJ, Mao YP, Ye RX, Wang QZ, Sun C, Sylvia S, Rozelle S, Raat H, Zhou H. Epidemiology, causes, clinical manifestation and diagnosis, prevention and control of coronavirus disease (COVID-19) during the early outbreak period: a scoping review. Infect Dis Poverty. 2020 Mar 17;9(1):29. doi: 10.1186/s40249-020-00646-x.
- Background: PubMed 19491438Adler A, Arnold JH, Bayford R, Borsic A, Brown B, Dixon P, Faes TJ, Frerichs I, Gagnon H, Garber Y, Grychtol B, Hahn G, Lionheart WR, Malik A, Patterson RP, Stocks J, Tizzard A, Weiler N, Wolf GK. GREIT: a unified approach to 2D linear EIT reconstruction of lung images. Physiol Meas. 2009 Jun;30(6):S35-55. doi: 10.1088/0967-3334/30/6/S03. Epub 2009 Jun 2.
- Background: PubMed 30776290Beitler JR, Sarge T, Banner-Goodspeed VM, Gong MN, Cook D, Novack V, Loring SH, Talmor D; EPVent-2 Study Group. Effect of Titrating Positive End-Expiratory Pressure (PEEP) With an Esophageal Pressure-Guided Strategy vs an Empirical High PEEP-Fio2 Strategy on Death and Days Free From Mechanical Ventilation Among Patients With Acute Respiratory Distress Syndrome: A Randomized Clinical Trial. JAMA. 2019 Mar 5;321(9):846-857. doi: 10.1001/jama.2019.0555.
- Background: PubMed 19255741Costa EL, Borges JB, Melo A, Suarez-Sipmann F, Toufen C Jr, Bohm SH, Amato MB. Bedside estimation of recruitable alveolar collapse and hyperdistension by electrical impedance tomography. Intensive Care Med. 2009 Jun;35(6):1132-7. doi: 10.1007/s00134-009-1447-y. Epub 2009 Mar 3.
- Background: PubMed 32171076Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11.
- Background: PubMed 24739268Frerichs I, Becher T, Weiler N. Electrical impedance tomography imaging of the cardiopulmonary system. Curr Opin Crit Care. 2014 Jun;20(3):323-32. doi: 10.1097/MCC.0000000000000088.
- Background: PubMed 29707281Fumagalli J, Berra L. What does the Acute Respiratory Distress Syndrome trial (ART) teach us?-it is time for precision medicine and precision trials in critical care! J Thorac Dis. 2018 Mar;10(3):1300-1303. doi: 10.21037/jtd.2018.03.31. No abstract available.
- Background: PubMed 32200400Goh KJ, Choong MC, Cheong EH, Kalimuddin S, Duu Wen S, Phua GC, Chan KS, Haja Mohideen S. Rapid Progression to Acute Respiratory Distress Syndrome: Review of Current Understanding of Critical Illness from Coronavirus Disease 2019 (COVID-19) Infection. Ann Acad Med Singap. 2020 Mar 16;49(3):108-118.
- Background: PubMed 19239703Huh JW, Jung H, Choi HS, Hong SB, Lim CM, Koh Y. Efficacy of positive end-expiratory pressure titration after the alveolar recruitment manoeuvre in patients with acute respiratory distress syndrome. Crit Care. 2009;13(1):R22. doi: 10.1186/cc7725. Epub 2009 Feb 24.
- Background: PubMed 27142073Liu S, Tan L, Moller K, Frerichs I, Yu T, Liu L, Huang Y, Guo F, Xu J, Yang Y, Qiu H, Zhao Z. Identification of regional overdistension, recruitment and cyclic alveolar collapse with electrical impedance tomography in an experimental ARDS model. Crit Care. 2016 May 3;20(1):119. doi: 10.1186/s13054-016-1300-y.
- Background: PubMed 3202424Murray JF, Matthay MA, Luce JM, Flick MR. An expanded definition of the adult respiratory distress syndrome. Am Rev Respir Dis. 1988 Sep;138(3):720-3. doi: 10.1164/ajrccm/138.3.720. No abstract available.
- Background: PubMed 31772068Sahetya SK, Hager DN, Stephens RS, Needham DM, Brower RG. PEEP Titration to Minimize Driving Pressure in Subjects With ARDS: A Prospective Physiological Study. Respir Care. 2020 May;65(5):583-589. doi: 10.4187/respcare.07102. Epub 2019 Nov 26.
- Individual participant dataSharing planned: Yes. * participant characteristics (age, gender) * clinical measurements (blood pressure, heart rate) * medical history * clinical laboratory results * images (X-rays) * adverse events (hemodynamic and respiratory instability, interruptions) * details of randomisation and treatment received
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REspiratory MEchanics for Delivering Individualised Exogenous Surfactant
Respiratory Distress Syndrome in Premature Infant
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.
Shirley Lima Campos, PhD study director
Universidade Federal de Pernambuco
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ARDSNet table, Driving Pressure and Electrical Impedance Tomography in people with Acute Respiratory Distress Syndrome (ARDS), run by University of Pernambuco at 4 sites in Brazil.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 7 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Brazil. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Murray Score (LIS) (time frame: 4 hours). The study lists 2 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 NCT05024500, which also lists 16 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 7 Mar 2023.