Association Between Tidal Volume and Mortality in Pressure Support in Adults Under Invasive Mechanical Ventilation
NCT ID: NCT06195475
Last Updated: 2025-05-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
2607 participants
OBSERVATIONAL
2023-11-30
2024-10-15
Brief Summary
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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
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Detailed Description
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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
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Study Design
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COHORT
OTHER
Study Groups
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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
high vs low tidal volume
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.
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
high vs low tidal volume
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.
Interventions
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high vs low tidal volume
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Javier Hernán Dorado
UNKNOWN
Joaquin Perez
UNKNOWN
Sanatorio Anchorena San Martin
OTHER
Responsible Party
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Matias Accoce
Respiratory and physical therapist
Locations
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Sanatorio Anchorena San Martín
Buenos Aires, Buenos Aires, Argentina
Countries
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References
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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.
Acute 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.
Gajic 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.
Serpa 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.
Hubmayr 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.
Murias G, Lucangelo U, Blanch L. Patient-ventilator asynchrony. Curr Opin Crit Care. 2016 Feb;22(1):53-9. doi: 10.1097/MCC.0000000000000270.
Plotnikow 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.
Kress 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.
Girard 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.
van 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.
Pinto 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.
Henzler 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.
Perez 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.
Bellani 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.
Yoshida 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.
Esteban A, Frutos-Vivar F, Muriel A, Ferguson ND, Penuelas O, Abraira V, Raymondos K, Rios F, Nin N, Apezteguia C, Violi DA, Thille AW, Brochard L, Gonzalez M, Villagomez AJ, Hurtado J, Davies AR, Du B, Maggiore SM, Pelosi P, Soto L, Tomicic V, D'Empaire G, Matamis D, Abroug F, Moreno RP, Soares MA, Arabi Y, Sandi F, Jibaja M, Amin P, Koh Y, Kuiper MA, Bulow HH, Zeggwagh AA, Anzueto A. Evolution of mortality over time in patients receiving mechanical ventilation. Am J Respir Crit Care Med. 2013 Jul 15;188(2):220-30. doi: 10.1164/rccm.201212-2169OC.
Abrams D, Montesi SB, Moore SKL, Manson DK, Klipper KM, Case MA, Brodie D, Beitler JR. Powering Bias and Clinically Important Treatment Effects in Randomized Trials of Critical Illness. Crit Care Med. 2020 Dec;48(12):1710-1719. doi: 10.1097/CCM.0000000000004568.
Related Links
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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 Pirika
Other Identifiers
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Sanatorio Anchorena San Martín
Identifier Type: -
Identifier Source: org_study_id
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