Respiration, ArtificialSAFE-VTNCT06195475
Association Between Tidal Volume and Mortality in Pressure Support in Adults Under Invasive Mechanical Ventilation
An observational study of Respiration, Artificial, run by Sanatorio Anchorena San Martin at 1 site in Argentina.
Trial summary
The goal of this Multicenter retrospective cohort study is to assessing the association between the development of a tidal volume magnitude > 8 ml/kg of predicted body weight during the first transition to partial support phase in pressure support mode and mortality in the intensive care unit in a general population… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiration, Artificial
- What is being tested?
- high vs low tidal volume
- How many people
- 2,607 participants
- Where
- 1 siteArgentina
- Study dates
- 30 Nov 2023to 15 Oct 2024
- How long will I take part?
- 28 Days
- 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 aged 18 years or older in invasive mechanical ventilation who have remained in PC-CSV for at least 24 hours
Who may be able to join
- Patients aged 18 and older admitted to the participating ICUs from January 1, 2019, to April 30, 2023, with a requirement for mechanical ventilation (MV) for any reason for at least 72 hours within the same cycle, who have at least one monitoring session in PC-CSV (pressure support ventilation), and who remain on MV (regardless of the mode) for a period of ≥ 1 calendar day after that monitoring session will be included
Who cannot join
- Patients who have not initiated the partial support phase in PC-CSV mode or who are extubated within a period of less than 24 hours from the first ventilatory monitoring in PC-CSV will be excluded. Subjects with missing data in exposure and/or outcome variables will also be excluded.
Trial locations and contacts
1 site in 1 country.
Argentina1 site
Sanatorio Anchorena San Martín
Buenos Aires, Buenos Aires, 1672
About this study
Official title: Impact of Tidal Volume Magnitude in Pressure Support Mode on Mortality in Adults Under Invasive Mechanical Ventilation. Multi-center Retrospective Cohort Study.
The goal of this Multicenter retrospective cohort study is to assessing the association between the development of a tidal volume magnitude > 8 ml/kg of predicted body weight during the first transition to partial support phase in pressure support mode and mortality in the intensive care unit in a general population of patients older than 18 years who require invasive mechanical ventilation, in contrast to individuals who develop tidal volume ≤ 8 ml/kg of predicted body weight. Secondarily, assess the association between elevated VT (tidal volume) during the initiation of the partial support phase in pressure support mode and ventilator-free days, failure in transitioning to spontaneous ventilation, and success in weaning from mechanical ventilation.
The main question it aims to answer are:
Read more
- Does exposure to tidal volumes greater than 8 ml/kg of predicted body weight during the first 48 hours of pressure support mode mechanical ventilation increase the risk of death in the intensive care unit compared to those who develop a tidal volume equal to or less than 8 ml/kg of predicted body weight in subjects older than 18 years requiring invasive mechanical ventilation?
The clinical investigation aims to determine whether exposure to tidal volumes greater than 8 ml/kg of predicted body weight during the initial 48 hours of pressure support mode mechanical ventilation is associated with an increased risk of mortality in the intensive care unit when compared to individuals who maintain a tidal volume equal to or less than 8 ml/kg of predicted body weight. This analysis involves subjects aged 18 years and older who require invasive mechanical ventilation
Read the detailed description
The data of patients from each participating center in the study will be encoded to maintain their anonymity. These center-related data will only be known to the study's Principal Investigator (PI), who will be the sole individual with access to them. Under no circumstances will the centers be able to make comparisons among themselves.
The data collected by each participating unit will be gathered by the investigator or by one of the designated team members assigned to the study, and entered into a REDCap® form specifically designed for this study.
The data collected by each investigator will be randomly supervised by the coordinating group to ensure the quality of the collected data and to detect possible errors in data acquisition. The study's coordinating group will also monitor the daily incorporation of data into the database to supervise and detect, as a double filter, the possibility of errors in data editing and incorporation, thus ensuring the quality and reliability of the information obtained throughout the entire period of patient inclusion.
- Conditions
- Respiration, Artificial
- Being tested
- high vs low tidal volume
- Keywords
- pressure support ventilation, tidal volume
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high vs low tidal volumeOther
The clinical investigation aims to determine whether exposure to tidal volumes greater than 8 ml/kg of predicted body weight during the initial 72 hours of pressure support mode mechanical ventilation is associated with an increased risk of mortality in the intensive care unit when compared to individuals who maintain a tidal volume equal to or less than 8 ml/kg of predicted body weight.
| Study group | Role | What they receive |
|---|---|---|
| exposure to tidal volumes greater than 8 ml/kg of predicted body weight | exposure to tidal volumes greater than 8 ml/kg of predicted body weight during the initial 48 hours of pressure support mode mechanical ventilation Receives: Other: high vs low tidal volume | |
| tidal volume equal to or less than 8 ml/kg of predicted body weight | individuals who maintain a tidal volume equal to or less than 8 ml/kg of predicted body weight Receives: Other: high vs low tidal volume |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality in intensive care unit
Categorical dichotomous variable (yes/no). All patients who are discharged from the intensive care unit (ICU), regardless of their destination (another area within the institution or another healthcare facility of any kind), will be considered as alive at ICU discharge.
Measured: day 28
Secondary outcomes (3)
Failure in transitioning to spontaneous ventilation
Categorical dichotomous variable (yes/no). It will be considered a failure in transitioning to spontaneous ventilation for any subject who, after having at least one monitoring session in PC-CSV mode, has at least one monitoring session in mandatory modes (VC-CMV and/or PC-CMV) within the following 72 hours.
Measured: 72 hours
Ventilator-free days
Discrete quantitative variable. To count each day of mechanical ventilation (MV), daily programming and respiratory mechanics monitoring will be used; considering one monitoring session as one day of MV. To obtain the final variable, the following equation will be used: 28 - days of invasive MV, resulting in a possible data range from 0 to 26 ventilator-free days.
Measured: 28 days
ICU length of stay
Discrete quantitative variable. It will be obtained using the following equation: (Date of ICU discharge) - (Date of ICU admission). Only the number of days of hospitalization will be required for the analysis.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2024
- Study start30 Nov 2023
- Primary completion15 Apr 2024
- Study completion15 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Respiration, ArtificialStudies 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
- Cohort
- Time perspective
- Other
- Enrolment
- 2,607 participants (actual)
- Target duration
- 28 Days
Sponsor and investigators
- Lead sponsor
- Sanatorio Anchorena San Martin
- Sponsor type
- University, hospital or other
- Collaborators
- Javier Hernán Dorado, Joaquin Perez
- Responsible party
- Principal investigator, Matias Accoce, Sanatorio Anchorena San Martin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06195475
- Sponsor's protocol ID
- Sanatorio Anchorena San Martín
- Acronym
- SAFE-VT
- Status last verified
- May 2025
- First submitted
- 3 Oct 2023
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Litell JM, Gong MN, Talmor D, Gajic O. Acute lung injury: prevention may be the best medicine. Respir Care. 2011 Oct;56(10):1546-54. doi: 10.4187/respcare.01361.
PubMed 22008396Acute 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 10793162Gajic O, Dara SI, Mendez JL, Adesanya AO, Festic E, Caples SM, Rana R, St Sauver JL, Lymp JF, Afessa B, Hubmayr RD. Ventilator-associated lung injury in patients without acute lung injury at the onset of mechanical ventilation. Crit Care Med. 2004 Sep;32(9):1817-24. doi: 10.1097/01.ccm.0000133019.52531.30.
PubMed 15343007Serpa Neto A, Cardoso SO, Manetta JA, Pereira VG, Esposito DC, Pasqualucci Mde O, Damasceno MC, Schultz MJ. Association between use of lung-protective ventilation with lower tidal volumes and clinical outcomes among patients without acute respiratory distress syndrome: a meta-analysis. JAMA. 2012 Oct 24;308(16):1651-9. doi: 10.1001/jama.2012.13730.
PubMed 23093163Hubmayr RD, Kallet RH. Understanding Pulmonary Stress-Strain Relationships in Severe ARDS and Its Implications for Designing a Safer Approach to Setting the Ventilator. Respir Care. 2018 Feb;63(2):219-226. doi: 10.4187/respcare.05900.
PubMed 29367383Murias G, Lucangelo U, Blanch L. Patient-ventilator asynchrony. Curr Opin Crit Care. 2016 Feb;22(1):53-9. doi: 10.1097/MCC.0000000000000270.
PubMed 26627539Plotnikow GA, Gogniat E, Accoce M, Navarro E, Dorado JH; EpVAr study group. Epidemiology of mechanical ventilation in Argentina. The EpVAr multicenter observational study. Med Intensiva (Engl Ed). 2022 Jul;46(7):372-382. doi: 10.1016/j.medine.2022.05.002. Epub 2022 May 31.
PubMed 35660286Kress JP, Pohlman AS, O'Connor MF, Hall JB. Daily interruption of sedative infusions in critically ill patients undergoing mechanical ventilation. N Engl J Med. 2000 May 18;342(20):1471-7. doi: 10.1056/NEJM200005183422002.
PubMed 10816184Girard TD, Kress JP, Fuchs BD, Thomason JW, Schweickert WD, Pun BT, Taichman DB, Dunn JG, Pohlman AS, Kinniry PA, Jackson JC, Canonico AE, Light RW, Shintani AK, Thompson JL, Gordon SM, Hall JB, Dittus RS, Bernard GR, Ely EW. Efficacy and safety of a paired sedation and ventilator weaning protocol for mechanically ventilated patients in intensive care (Awakening and Breathing Controlled trial): a randomised controlled trial. Lancet. 2008 Jan 12;371(9607):126-34. doi: 10.1016/S0140-6736(08)60105-1.
PubMed 18191684van Haren F, Pham T, Brochard L, Bellani G, Laffey J, Dres M, Fan E, Goligher EC, Heunks L, Lynch J, Wrigge H, McAuley D; Large observational study to UNderstand the Global impact of Severe Acute respiratory FailurE (LUNG SAFE) Investigators. Spontaneous Breathing in Early Acute Respiratory Distress Syndrome: Insights From the Large Observational Study to UNderstand the Global Impact of Severe Acute Respiratory FailurE Study. Crit Care Med. 2019 Feb;47(2):229-238. doi: 10.1097/CCM.0000000000003519.
PubMed 30379668Pinto EF, Santos RS, Antunes MA, Maia LA, Padilha GA, de A Machado J, Carvalho ACF, Fernandes MVS, Capelozzi VL, de Abreu MG, Pelosi P, Rocco PRM, Silva PL. Static and Dynamic Transpulmonary Driving Pressures Affect Lung and Diaphragm Injury during Pressure-controlled versus Pressure-support Ventilation in Experimental Mild Lung Injury in Rats. Anesthesiology. 2020 Feb;132(2):307-320. doi: 10.1097/ALN.0000000000003060.
PubMed 31939846Henzler D, Schmidt A, Xu Z, Ismaiel N, Zhang H, Slutsky AS, Pelosi P. Increased effort during partial ventilatory support is not associated with lung damage in experimental acute lung injury. Intensive Care Med Exp. 2019 Nov 5;7(1):60. doi: 10.1186/s40635-019-0272-z.
PubMed 31691042Perez J, Dorado JH, Papazian AC, Berastegui M, Gilgado DI, Cardoso GP, Cesio C, Accoce M. Titration and characteristics of pressure-support ventilation use in Argentina: an online cross-sectional survey study. Rev Bras Ter Intensiva. 2020 Mar;32(1):81-91. doi: 10.5935/0103-507x.20200013. Epub 2020 May 8.
PubMed 32401994Bellani G, Grassi A, Sosio S, Gatti S, Kavanagh BP, Pesenti A, Foti G. Driving Pressure Is Associated with Outcome during Assisted Ventilation in Acute Respiratory Distress Syndrome. Anesthesiology. 2019 Sep;131(3):594-604. doi: 10.1097/ALN.0000000000002846.
PubMed 31335543Yoshida T, Fujino Y, Amato MB, Kavanagh BP. Fifty Years of Research in ARDS. Spontaneous Breathing during Mechanical Ventilation. Risks, Mechanisms, and Management. Am J Respir Crit Care Med. 2017 Apr 15;195(8):985-992. doi: 10.1164/rccm.201604-0748CP.
PubMed 27786562
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Tidal Volume Magnitude in Pressure Support Mode on Mortality in Adults Under Invasive Mechanical Ventilation. Multi-center Retrospective Cohort Study.
- ClinicalTrials.gov ID
- NCT06195475
- Acronym / sponsor ID
- SAFE-VT / Sanatorio Anchorena San Martín
- Conditions
- Respiration, Artificial
- Keywords
- pressure support ventilation, tidal volume
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,607 participants (actual)
- Lead sponsor
- Sanatorio Anchorena San MartinUniversity, hospital or other
- Collaborators
- Javier Hernán Dorado, Joaquin Perez
- Study start
- 30 Nov 2023 (actual)
- Primary completion
- 15 Apr 2024 (actual)
- Study completion
- 15 Oct 2024 (actual)
- First posted
- 8 Jan 2024 (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 Multicenter retrospective cohort study is to assessing the association between the development of a tidal volume magnitude > 8 ml/kg of predicted body weight during the first transition to partial support phase in pressure support mode and mortality in the intensive care unit in a general population of patients older than 18 years who require invasive mechanical ventilation, in contrast to individuals who develop tidal volume ≤ 8 ml/kg of predicted body weight. Secondarily, assess the association between elevated VT (tidal volume) during the initiation of the partial support phase in pressure support mode and ventilator-free days, failure in transitioning to spontaneous ventilation, and success in weaning from mechanical ventilation.
The main question it aims to answer are:
- Does exposure to tidal volumes greater than 8 ml/kg of predicted body weight during the first 48 hours of pressure support mode mechanical ventilation increase the risk of death in the intensive care unit compared to those who develop a tidal volume equal to or less than 8 ml/kg of predicted body weight in subjects older than 18 years requiring invasive mechanical ventilation?
The clinical investigation aims to determine whether exposure to tidal volumes greater than 8 ml/kg of predicted body weight during the initial 48 hours of pressure support mode mechanical ventilation is associated with an increased risk of mortality in the intensive care unit when compared to individuals who maintain a tidal volume equal to or less than 8 ml/kg of predicted body weight. This analysis involves subjects aged 18 years and older who require invasive mechanical ventilation
Detailed description
The data of patients from each participating center in the study will be encoded to maintain their anonymity. These center-related data will only be known to the study's Principal Investigator (PI), who will be the sole individual with access to them. Under no circumstances will the centers be able to make comparisons among themselves.
The data collected by each participating unit will be gathered by the investigator or by one of the designated team members assigned to the study, and entered into a REDCap® form specifically designed for this study.
The data collected by each investigator will be randomly supervised by the coordinating group to ensure the quality of the collected data and to detect possible errors in data acquisition. The study's coordinating group will also monitor the daily incorporation of data into the database to supervise and detect, as a double filter, the possibility of errors in data editing and incorporation, thus ensuring the quality and reliability of the information obtained throughout the entire period of patient inclusion.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 28 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| exposure to tidal volumes greater than 8 ml/kg of predicted body weight | – | Other: high vs low tidal volumeexposure to tidal volumes greater than 8 ml/kg of predicted body weight during the initial 48 hours of pressure support mode mechanical ventilation |
| tidal volume equal to or less than 8 ml/kg of predicted body weight | – | Other: high vs low tidal volumeindividuals who maintain a tidal volume equal to or less than 8 ml/kg of predicted body weight |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18 years or older in invasive mechanical ventilation who have remained in PC-CSV for at least 24 hours
Key inclusion criteria (1 listed)
- Patients aged 18 and older admitted to the participating ICUs from January 1, 2019, to April 30, 2023, with a requirement for mechanical ventilation (MV) for any reason for at least 72 hours within the same cycle, who have at least one monitoring session in PC-CSV (pressure support ventilation), and who remain on MV (regardless of the mode) for a period of ≥ 1 calendar day after that monitoring session will be included
Key exclusion criteria (1 listed)
- Patients who have not initiated the partial support phase in PC-CSV mode or who are extubated within a period of less than 24 hours from the first ventilatory monitoring in PC-CSV will be excluded. Subjects with missing data in exposure and/or outcome variables will also be excluded.
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 vs low tidal volumeThe clinical investigation aims to determine whether exposure to tidal volumes greater than 8 ml/kg of predicted body weight during the initial 72 hours of pressure support mode mechanical ventilation is associated with an increased risk of mortality in the intensive care unit when compared to individuals who maintain a tidal volume equal to or less than 8 ml/kg of predicted body weight. | Other | exposure to tidal volumes greater than 8 ml/kg of predicted body weight, tidal volume equal to or less than 8 ml/kg of predicted body weight |
Primary outcome
mortality in intensive care unit
Time frame: day 28
Categorical dichotomous variable (yes/no). All patients who are discharged from the intensive care unit (ICU), regardless of their destination (another area within the institution or another healthcare facility of any kind), will be considered as alive at ICU discharge.
3 secondary outcomes
Failure in transitioning to spontaneous ventilation
Time frame: 72 hours
Ventilator-free days
Time frame: 28 days
ICU length of stay
Time frame: 28 days
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 15 May 2025.
- Results publication: PubMed 22008396Litell JM, Gong MN, Talmor D, Gajic O. Acute lung injury: prevention may be the best medicine. Respir Care. 2011 Oct;56(10):1546-54. doi: 10.4187/respcare.01361.
- Results publication: 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.
- Results publication: PubMed 15343007Gajic O, Dara SI, Mendez JL, Adesanya AO, Festic E, Caples SM, Rana R, St Sauver JL, Lymp JF, Afessa B, Hubmayr RD. Ventilator-associated lung injury in patients without acute lung injury at the onset of mechanical ventilation. Crit Care Med. 2004 Sep;32(9):1817-24. doi: 10.1097/01.ccm.0000133019.52531.30.
- Results publication: PubMed 23093163Serpa Neto A, Cardoso SO, Manetta JA, Pereira VG, Esposito DC, Pasqualucci Mde O, Damasceno MC, Schultz MJ. Association between use of lung-protective ventilation with lower tidal volumes and clinical outcomes among patients without acute respiratory distress syndrome: a meta-analysis. JAMA. 2012 Oct 24;308(16):1651-9. doi: 10.1001/jama.2012.13730.
- Results publication: PubMed 29367383Hubmayr RD, Kallet RH. Understanding Pulmonary Stress-Strain Relationships in Severe ARDS and Its Implications for Designing a Safer Approach to Setting the Ventilator. Respir Care. 2018 Feb;63(2):219-226. doi: 10.4187/respcare.05900.
- Results publication: PubMed 26627539Murias G, Lucangelo U, Blanch L. Patient-ventilator asynchrony. Curr Opin Crit Care. 2016 Feb;22(1):53-9. doi: 10.1097/MCC.0000000000000270.
- Results publication: PubMed 35660286Plotnikow GA, Gogniat E, Accoce M, Navarro E, Dorado JH; EpVAr study group. Epidemiology of mechanical ventilation in Argentina. The EpVAr multicenter observational study. Med Intensiva (Engl Ed). 2022 Jul;46(7):372-382. doi: 10.1016/j.medine.2022.05.002. Epub 2022 May 31.
- Results publication: PubMed 10816184Kress JP, Pohlman AS, O'Connor MF, Hall JB. Daily interruption of sedative infusions in critically ill patients undergoing mechanical ventilation. N Engl J Med. 2000 May 18;342(20):1471-7. doi: 10.1056/NEJM200005183422002.
- Results publication: PubMed 18191684Girard TD, Kress JP, Fuchs BD, Thomason JW, Schweickert WD, Pun BT, Taichman DB, Dunn JG, Pohlman AS, Kinniry PA, Jackson JC, Canonico AE, Light RW, Shintani AK, Thompson JL, Gordon SM, Hall JB, Dittus RS, Bernard GR, Ely EW. Efficacy and safety of a paired sedation and ventilator weaning protocol for mechanically ventilated patients in intensive care (Awakening and Breathing Controlled trial): a randomised controlled trial. Lancet. 2008 Jan 12;371(9607):126-34. doi: 10.1016/S0140-6736(08)60105-1.
- Results publication: PubMed 30379668van Haren F, Pham T, Brochard L, Bellani G, Laffey J, Dres M, Fan E, Goligher EC, Heunks L, Lynch J, Wrigge H, McAuley D; Large observational study to UNderstand the Global impact of Severe Acute respiratory FailurE (LUNG SAFE) Investigators. Spontaneous Breathing in Early Acute Respiratory Distress Syndrome: Insights From the Large Observational Study to UNderstand the Global Impact of Severe Acute Respiratory FailurE Study. Crit Care Med. 2019 Feb;47(2):229-238. doi: 10.1097/CCM.0000000000003519.
- Results publication: PubMed 31939846Pinto EF, Santos RS, Antunes MA, Maia LA, Padilha GA, de A Machado J, Carvalho ACF, Fernandes MVS, Capelozzi VL, de Abreu MG, Pelosi P, Rocco PRM, Silva PL. Static and Dynamic Transpulmonary Driving Pressures Affect Lung and Diaphragm Injury during Pressure-controlled versus Pressure-support Ventilation in Experimental Mild Lung Injury in Rats. Anesthesiology. 2020 Feb;132(2):307-320. doi: 10.1097/ALN.0000000000003060.
- Results publication: PubMed 31691042Henzler D, Schmidt A, Xu Z, Ismaiel N, Zhang H, Slutsky AS, Pelosi P. Increased effort during partial ventilatory support is not associated with lung damage in experimental acute lung injury. Intensive Care Med Exp. 2019 Nov 5;7(1):60. doi: 10.1186/s40635-019-0272-z.
- Mark Stevenson, Evan Sergeant with contributions from Telmo Nunes, Cord Heuer, Jonathon Marshall, Javier Sanchez, Ron Thornton, Jeno Reiczigel, Jim Robison-Cox, Paola Sebastiani, Peter Solymos, Kazuki Yoshida, Geoff Jones, Sarah PirikaLink provided by the sponsor.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Respiration, Artificial, 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 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 15 May 2025. 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?
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?
mortality in intensive care unit (time frame: day 28). 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 NCT06195475, which also lists 17 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 15 May 2025.