Respiratory FailureNCT05820347
Muscle Pressure Estimation With Artificial Intelligence During Mechanical Ventilation
A study testing Artificial Intelligence Estimation of Muscle Pressure during Mechanical Ventilation in people with Respiratory Failure, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
The goal of this diagnostic study is to validate estimation of inspiratory muscle pressure by an artificial intelligence algorithm compared to the gold standard, the measure from an esophageal catheter balloon, in patients under assisted mechanical ventilation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Failure
- What is being tested?
- Artificial Intelligence Estimation of Muscle Pressure during Mechanical Ventilation
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- 26 Aug 2022to 18 Jul 2023
- 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
- Patients under assisted or assist-control mechanical ventilation
Who cannot join
- Contraindication to esophageal catheter insertion (esophageal cancer or bleeding, esophageal fistula, skull base fracture, uncontrolled coagulopathies)
- Contraindication to transient neuromuscular blockade
- Bronchopleural fistula (persistent air leak)
- Hemodynamic instability (norepinephrine > 1mcg/kg/min)
- Gestation
- Current sinus infection
- Refusal from patient's family of attending physician
- Palliative care
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Heart Institute, University of São Paulo
São Paulo, São Paulo, 05403900
About this study
Official title: Validation of Inspiratory Muscle Pressure Estimation and Automated Detection of Asynchronies in Patients Under Assisted Mechanical Ventilation
The goal of this diagnostic study is to validate estimation of inspiratory muscle pressure by an artificial intelligence algorithm compared to the gold standard, the measure from an esophageal catheter balloon, in patients under assisted mechanical ventilation. The main questions it aims to answer are:
- Are inspiratory muscle pressure estimates from an artificial intelligence algorithm accurate when compared to the direct measure from an esophageal balloon?
Participants will be monitored with an esophageal balloon and with an artificial intelligence algorithm simultaneously, with inspiratory muscle pressure estimation during assisted mechanical ventilation with decremental levels of pressure support.
Read the detailed description
This is a diagnostic study to validate estimation of inspiratory muscle pressure during assisted ventilation from an artificial intelligence algorithm integrated in a mechanical ventilator (FlexiMag, Magnamed, Brazil) compared to direct measure of muscle pressure from esophageal catheter balloon (gold standard). This is a novel non-invasive method to estimate inspiratory muscle pressure.
After obtaining informed consent, participants will be monitored simultaneously with the esophageal balloon and the artificial intelligence algorithm, with decremental levels of pressure support (20 to 2 cmH2O, in steps of 20 minutes). Esophageal balloon will be removed after completing the last pressure support step.
The investigators estimated a sample of 50 participants, considering 3 cmH2O as a clinically relevant discordance between methods and 10% of missing data. Concordance analysis and correlation analysis will be performed.
Procedures will follow a specific Standard Operating Procedures and participants inclusion data will be inserted in REDCap.
- Conditions
- Respiratory Failure
- Being tested
- Artificial Intelligence Estimation of Muscle Pressure during Mechanical Ventilation
- Keywords
- mechanical ventilation, artificial intelligence
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artificial Intelligence Estimation of Muscle Pressure during Mechanical VentilationDevice
Also called Esophageal balloon measurements of Muscle Pressure, Transient Neuromuscular Blockade with Succinylcholine or Rocuronium to measure Respiratory Mechanics, Electrical Impedance Tomography Monitorization
Estimation of inspiratory muscle pressure by an artificial intelligence algorithm integrated in the mechanical ventilator (FlexiMag, Magnamed, Brazil).
| Study group | Role | What they receive |
|---|---|---|
| Artificial Intelligence Estimation of Muscle Pressure during Mechanical Ventilation | Other | All included subjects will be monitored simultaneously with the esophageal balloon (gold standard) and with the artificial intelligence algorithm integrated in the mechanical ventilator. Electrical Impedance Tomography will be used to monitor ventilatory patterns during different degrees of spontaneous effort. First, a single intravenous bolus of neuromuscular blockade (succinylcholine 1mg/kg or rocuronium 1.2mg/kg) will be performed to measure respiratory system mechanics (compliance and resistance). In cases where rocuronium is used, a single dose of sugammadex 4mg/kg will be administered intravenously to reverse neuromuscular blockade after measuring compliance and resistance. After initiation of spontaneous breathing effort, pressure support will be titrated from 20 cmH2O to 2 cmH2O, in decremental steps during 20 minutes each. After completing titrating of pressure support, the esophageal balloon will be removed. Receives: Device: Artificial Intelligence Estimation of Muscle Pressure during Mechanical Ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance between muscle pressure amplitude (in cmH2O) estimation by artificial intelligence and esophageal balloon
Analysis of the bias and limits of agreement (Bland-Altman plot) between muscle pressure estimated amplitude in cmH2O from artificial intelligence and measured by esophageal balloon.
Measured: 4 hours
Correlation between muscle pressure amplitude estimation (in cmH2O) by artificial intelligence and esophageal balloon
Correlation, reported as R-squared and a correlation plot, between amplitude in cmH2O of muscle pressure estimation by artificial intelligence and esophageal balloon.
Measured: 4 hours
Detection of initiation time and ending time of a spontaneous breathing cycle by artificial intelligence compared with esophageal balloon
Time difference (in ms) between initiation of a spontaneous breathing cycle and ending of a spontaneous breathing cycle between artificial intelligence and esophageal balloon.
Measured: 4 hours
Secondary outcomes (1)
Sensitivity and specificity of patient-ventilator asynchrony automated detection using the Artificial Intelligence Muscle Pressure estimator
Number of patient-ventilator asynchronies detected using artificial intelligence compared with number of asynchronies detected by experts assessing airway pressure, flow and esophageal balloon waveforms.
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2023
- Study start26 Aug 2022
- Primary completion18 Jul 2023
- Study completion18 Jul 2023
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 Respiratory FailureStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Magnamed Tecnologia Medica S/A
- Responsible party
- Sponsor
- Investigators
- Eduardo LV Costa, MD, PhD, Principal investigator, University of Sao PauloMarcelo BP Amato, MD, PhD, Study chair, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05820347
- Sponsor's protocol ID
- CAAE: 59353422.9.0000.0068
- Status last verified
- Mar 2023
- First submitted
- 16 Mar 2023
- Last updated
- 6 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Amato MB, Barbas CS, Medeiros DM, Magaldi RB, Schettino GP, Lorenzi-Filho G, Kairalla RA, Deheinzelin D, Munoz C, Oliveira R, Takagaki TY, Carvalho CR. Effect of a protective-ventilation strategy on mortality in the acute respiratory distress syndrome. N Engl J Med. 1998 Feb 5;338(6):347-54. doi: 10.1056/NEJM199802053380602.
PubMed 9449727Acute Respiratory Distress Syndrome Network; Brower RG, Matthay MA, Morris A, Schoenfeld D, Thompson BT, Wheeler A. Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med. 2000 May 4;342(18):1301-8. doi: 10.1056/NEJM200005043421801.
PubMed 10793162Loring SH, Malhotra A. Driving pressure and respiratory mechanics in ARDS. N Engl J Med. 2015 Feb 19;372(8):776-7. doi: 10.1056/NEJMe1414218. No abstract available.
PubMed 25693019Yoshida T, Torsani V, Gomes S, De Santis RR, Beraldo MA, Costa EL, Tucci MR, Zin WA, Kavanagh BP, Amato MB. Spontaneous effort causes occult pendelluft during mechanical ventilation. Am J Respir Crit Care Med. 2013 Dec 15;188(12):1420-7. doi: 10.1164/rccm.201303-0539OC.
PubMed 24199628Yoshida T, Roldan R, Beraldo MA, Torsani V, Gomes S, De Santis RR, Costa EL, Tucci MR, Lima RG, Kavanagh BP, Amato MB. Spontaneous Effort During Mechanical Ventilation: Maximal Injury With Less Positive End-Expiratory Pressure. Crit Care Med. 2016 Aug;44(8):e678-88. doi: 10.1097/CCM.0000000000001649.
PubMed 27002273Yoshida 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 29323931Morais CCA, Koyama Y, Yoshida T, Plens GM, Gomes S, Lima CAS, Ramos OPS, Pereira SM, Kawaguchi N, Yamamoto H, Uchiyama A, Borges JB, Vidal Melo MF, Tucci MR, Amato MBP, Kavanagh BP, Costa ELV, Fujino Y. High Positive End-Expiratory Pressure Renders Spontaneous Effort Noninjurious. Am J Respir Crit Care Med. 2018 May 15;197(10):1285-1296. doi: 10.1164/rccm.201706-1244OC.
PubMed 29323536Sousa MLEA, Magrans R, Hayashi FK, Blanch L, Kacmarek RM, Ferreira JC. Clusters of Double Triggering Impact Clinical Outcomes: Insights From the EPIdemiology of Patient-Ventilator aSYNChrony (EPISYNC) Cohort Study. Crit Care Med. 2021 Sep 1;49(9):1460-1469. doi: 10.1097/CCM.0000000000005029.
PubMed 33883458Sousa MLA, Magrans R, Hayashi FK, Blanch L, Kacmarek RM, Ferreira JC. Predictors of asynchronies during assisted ventilation and its impact on clinical outcomes: The EPISYNC cohort study. J Crit Care. 2020 Jun;57:30-35. doi: 10.1016/j.jcrc.2020.01.023. Epub 2020 Jan 21.
PubMed 32032901Blanch L, Villagra A, Sales B, Montanya J, Lucangelo U, Lujan M, Garcia-Esquirol O, Chacon E, Estruga A, Oliva JC, Hernandez-Abadia A, Albaiceta GM, Fernandez-Mondejar E, Fernandez R, Lopez-Aguilar J, Villar J, Murias G, Kacmarek RM. Asynchronies during mechanical ventilation are associated with mortality. Intensive Care Med. 2015 Apr;41(4):633-41. doi: 10.1007/s00134-015-3692-6. Epub 2015 Feb 19.
PubMed 25693449LeCun Y, Bengio Y, Hinton G. Deep learning. Nature. 2015 May 28;521(7553):436-44. doi: 10.1038/nature14539.
PubMed 26017442Pletsch-Assuncao R, Caleffi Pereira M, Ferreira JG, Cardenas LZ, de Albuquerque ALP, de Carvalho CRR, Caruso P. Accuracy of Invasive and Noninvasive Parameters for Diagnosing Ventilatory Overassistance During Pressure Support Ventilation. Crit Care Med. 2018 Mar;46(3):411-417. doi: 10.1097/CCM.0000000000002871.
PubMed 29189344Baydur A, Behrakis PK, Zin WA, Jaeger M, Milic-Emili J. A simple method for assessing the validity of the esophageal balloon technique. Am Rev Respir Dis. 1982 Nov;126(5):788-91. doi: 10.1164/arrd.1982.126.5.788.
PubMed 7149443Liao JJ. Sample size calculation for an agreement study. Pharm Stat. 2010 Apr-Jun;9(2):125-32. doi: 10.1002/pst.382.
PubMed 19507134Motta APG, Rigobello MCG, Silveira RCCP, Gimenes FRE. Nasogastric/nasoenteric tube-related adverse events: an integrative review. Rev Lat Am Enfermagem. 2021 Jan 8;29:e3400. doi: 10.1590/1518-8345.3355.3400. eCollection 2021.
PubMed 33439952
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Inspiratory Muscle Pressure Estimation and Automated Detection of Asynchronies in Patients Under Assisted Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT05820347
- Acronym / sponsor ID
- CAAE: 59353422.9.0000.0068
- Conditions
- Respiratory Failure
- Keywords
- mechanical ventilation, artificial intelligence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- Magnamed Tecnologia Medica S/A
- Study start
- 26 Aug 2022 (actual)
- Primary completion
- 18 Jul 2023 (actual)
- Study completion
- 18 Jul 2023 (actual)
- First posted
- 19 Apr 2023 (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 goal of this diagnostic study is to validate estimation of inspiratory muscle pressure by an artificial intelligence algorithm compared to the gold standard, the measure from an esophageal catheter balloon, in patients under assisted mechanical ventilation. The main questions it aims to answer are:
- Are inspiratory muscle pressure estimates from an artificial intelligence algorithm accurate when compared to the direct measure from an esophageal balloon?
Participants will be monitored with an esophageal balloon and with an artificial intelligence algorithm simultaneously, with inspiratory muscle pressure estimation during assisted mechanical ventilation with decremental levels of pressure support.
Detailed description
This is a diagnostic study to validate estimation of inspiratory muscle pressure during assisted ventilation from an artificial intelligence algorithm integrated in a mechanical ventilator (FlexiMag, Magnamed, Brazil) compared to direct measure of muscle pressure from esophageal catheter balloon (gold standard). This is a novel non-invasive method to estimate inspiratory muscle pressure.
After obtaining informed consent, participants will be monitored simultaneously with the esophageal balloon and the artificial intelligence algorithm, with decremental levels of pressure support (20 to 2 cmH2O, in steps of 20 minutes). Esophageal balloon will be removed after completing the last pressure support step.
The investigators estimated a sample of 50 participants, considering 3 cmH2O as a clinically relevant discordance between methods and 10% of missing data. Concordance analysis and correlation analysis will be performed.
Procedures will follow a specific Standard Operating Procedures and participants inclusion data will be inserted in REDCap.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Artificial Intelligence Estimation of Muscle Pressure during Mechanical Ventilation | Other | Device: Artificial Intelligence Estimation of Muscle Pressure during Mechanical VentilationAll included subjects will be monitored simultaneously with the esophageal balloon (gold standard) and with the artificial intelligence algorithm integrated in the mechanical ventilator. Electrical Impedance Tomography will be used to monitor ventilatory patterns during different degrees of spontaneous effort. First, a single intravenous bolus of neuromuscular blockade (succinylcholine 1mg/kg or rocuronium 1.2mg/kg) will be performed to measure respiratory system mechanics (compliance and resistance). In cases where rocuronium is used, a single dose of sugammadex 4mg/kg will be administered intravenously to reverse neuromuscular blockade after measuring compliance and resistance. After initiation of spontaneous breathing effort, pressure support will be titrated from 20 cmH2O to 2 cmH2O, in decremental steps during 20 minutes each. After completing titrating of pressure support, the esophageal balloon will be removed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients under assisted or assist-control mechanical ventilation
Key exclusion criteria (8 listed)
- Contraindication to esophageal catheter insertion (esophageal cancer or bleeding, esophageal fistula, skull base fracture, uncontrolled coagulopathies)
- Contraindication to transient neuromuscular blockade
- Bronchopleural fistula (persistent air leak)
- Hemodynamic instability (norepinephrine > 1mcg/kg/min)
- Gestation
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 |
|---|---|---|
| Artificial Intelligence Estimation of Muscle Pressure during Mechanical VentilationAlso: Esophageal balloon measurements of Muscle Pressure, Transient Neuromuscular Blockade with Succinylcholine or Rocuronium to measure Respiratory Mechanics, Electrical Impedance Tomography MonitorizationEstimation of inspiratory muscle pressure by an artificial intelligence algorithm integrated in the mechanical ventilator (FlexiMag, Magnamed, Brazil). | Device | Artificial Intelligence Estimation of Muscle Pressure during Mechanical Ventilation |
Primary outcome
Concordance between muscle pressure amplitude (in cmH2O) estimation by artificial intelligence and esophageal balloon
Time frame: 4 hours
Analysis of the bias and limits of agreement (Bland-Altman plot) between muscle pressure estimated amplitude in cmH2O from artificial intelligence and measured by esophageal balloon.
Correlation between muscle pressure amplitude estimation (in cmH2O) by artificial intelligence and esophageal balloon
Time frame: 4 hours
Correlation, reported as R-squared and a correlation plot, between amplitude in cmH2O of muscle pressure estimation by artificial intelligence and esophageal balloon.
Detection of initiation time and ending time of a spontaneous breathing cycle by artificial intelligence compared with esophageal balloon
Time frame: 4 hours
Time difference (in ms) between initiation of a spontaneous breathing cycle and ending of a spontaneous breathing cycle between artificial intelligence and esophageal balloon.
1 secondary outcome
Sensitivity and specificity of patient-ventilator asynchrony automated detection using the Artificial Intelligence Muscle Pressure estimator
Time frame: 4 hours
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 6 Sep 2023.
- Background: PubMed 9449727Amato MB, Barbas CS, Medeiros DM, Magaldi RB, Schettino GP, Lorenzi-Filho G, Kairalla RA, Deheinzelin D, Munoz C, Oliveira R, Takagaki TY, Carvalho CR. Effect of a protective-ventilation strategy on mortality in the acute respiratory distress syndrome. N Engl J Med. 1998 Feb 5;338(6):347-54. doi: 10.1056/NEJM199802053380602.
- Background: PubMed 10793162Acute Respiratory Distress Syndrome Network; Brower RG, Matthay MA, Morris A, Schoenfeld D, Thompson BT, Wheeler A. Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med. 2000 May 4;342(18):1301-8. doi: 10.1056/NEJM200005043421801.
- Background: PubMed 25693019Loring SH, Malhotra A. Driving pressure and respiratory mechanics in ARDS. N Engl J Med. 2015 Feb 19;372(8):776-7. doi: 10.1056/NEJMe1414218. No abstract available.
- Background: PubMed 24199628Yoshida T, Torsani V, Gomes S, De Santis RR, Beraldo MA, Costa EL, Tucci MR, Zin WA, Kavanagh BP, Amato MB. Spontaneous effort causes occult pendelluft during mechanical ventilation. Am J Respir Crit Care Med. 2013 Dec 15;188(12):1420-7. doi: 10.1164/rccm.201303-0539OC.
- Background: PubMed 27002273Yoshida T, Roldan R, Beraldo MA, Torsani V, Gomes S, De Santis RR, Costa EL, Tucci MR, Lima RG, Kavanagh BP, Amato MB. Spontaneous Effort During Mechanical Ventilation: Maximal Injury With Less Positive End-Expiratory Pressure. Crit Care Med. 2016 Aug;44(8):e678-88. doi: 10.1097/CCM.0000000000001649.
- Background: PubMed 29323931Yoshida 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.
- Background: PubMed 29323536Morais CCA, Koyama Y, Yoshida T, Plens GM, Gomes S, Lima CAS, Ramos OPS, Pereira SM, Kawaguchi N, Yamamoto H, Uchiyama A, Borges JB, Vidal Melo MF, Tucci MR, Amato MBP, Kavanagh BP, Costa ELV, Fujino Y. High Positive End-Expiratory Pressure Renders Spontaneous Effort Noninjurious. Am J Respir Crit Care Med. 2018 May 15;197(10):1285-1296. doi: 10.1164/rccm.201706-1244OC.
- Background: PubMed 33883458Sousa MLEA, Magrans R, Hayashi FK, Blanch L, Kacmarek RM, Ferreira JC. Clusters of Double Triggering Impact Clinical Outcomes: Insights From the EPIdemiology of Patient-Ventilator aSYNChrony (EPISYNC) Cohort Study. Crit Care Med. 2021 Sep 1;49(9):1460-1469. doi: 10.1097/CCM.0000000000005029.
- Background: PubMed 32032901Sousa MLA, Magrans R, Hayashi FK, Blanch L, Kacmarek RM, Ferreira JC. Predictors of asynchronies during assisted ventilation and its impact on clinical outcomes: The EPISYNC cohort study. J Crit Care. 2020 Jun;57:30-35. doi: 10.1016/j.jcrc.2020.01.023. Epub 2020 Jan 21.
- Background: PubMed 25693449Blanch L, Villagra A, Sales B, Montanya J, Lucangelo U, Lujan M, Garcia-Esquirol O, Chacon E, Estruga A, Oliva JC, Hernandez-Abadia A, Albaiceta GM, Fernandez-Mondejar E, Fernandez R, Lopez-Aguilar J, Villar J, Murias G, Kacmarek RM. Asynchronies during mechanical ventilation are associated with mortality. Intensive Care Med. 2015 Apr;41(4):633-41. doi: 10.1007/s00134-015-3692-6. Epub 2015 Feb 19.
- Background: PubMed 26017442LeCun Y, Bengio Y, Hinton G. Deep learning. Nature. 2015 May 28;521(7553):436-44. doi: 10.1038/nature14539.
- Background: PubMed 29189344Pletsch-Assuncao R, Caleffi Pereira M, Ferreira JG, Cardenas LZ, de Albuquerque ALP, de Carvalho CRR, Caruso P. Accuracy of Invasive and Noninvasive Parameters for Diagnosing Ventilatory Overassistance During Pressure Support Ventilation. Crit Care Med. 2018 Mar;46(3):411-417. doi: 10.1097/CCM.0000000000002871.
- 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.
Eduardo LV Costa, MD, PhD principal investigator
University of Sao Paulo
Marcelo BP Amato, MD, PhD study chair
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Artificial Intelligence Estimation of Muscle Pressure during Mechanical Ventilation in people with Respiratory Failure, run by University of Sao Paulo General Hospital at 1 site 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 8 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 6 Sep 2023. 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 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?
Concordance between muscle pressure amplitude (in cmH2O) estimation by artificial intelligence and esophageal balloon (time frame: 4 hours). 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 NCT05820347, 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 6 Sep 2023; AzTrials last refreshed its copy on 2 Nov 2026.