Acute Respiratory Failure Clinical Trial
— P1P2DecayOfficial title:
Effect of Different Measurements of End-inspiratory Airway Pressure on Driving Pressure and Mechanical Power in Mechanically Ventilated Patients: the P1-P2 Decay Study
NCT number | NCT05991258 |
Other study ID # | 5607/AO/22 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | March 9, 2023 |
Est. completion date | December 31, 2024 |
Mechanical ventilation may be associated with ventilator-induced lung injury (VILI). Several respiratory variables have been employed to estimate the risk of VILI, such as tidal volumes, plateau pressure, driving pressure, and mechanical power. This dissipation of energy during ventilation can contribute to VILI through two mechanisms, stress relaxation and pendelluft, which can be estimated at the bedside by applying an end-inspiratory pause and evaluating the slow decrease in airway pressure going from the pressure corresponding to zero flow (called pressure P1) and the final pressure at the end of the pause (called plateau pressure P2). The choice of measuring the end-inspiratory airway pressure (PawEND-INSP) at a fixed, although relatively early, timepoint, i.e., after 0.5 second from the beginning of the pause, as prescribed by the indications of the Acute Respiratory Distress Syndrome (ARDS) Network, while assessing the risk of VILI associated with the elastic pressure of the respiratory system, may not reflect the harmful potential associated with the viscoelastic properties of the respiratory system. It is still unclear whether an PawEND-INSP measured at the exact moment of zero flow (P1) is more reliable in the calculation of those variables, such as ΔP and MP, associated with the outcomes of patients with and without ARDS, as compared to the pressure measured at the end of the end-inspiratory pause (plateau pressure P2). This multicenter prospective observational study aims to evaluate whether the use of P1, as compared to P2, affects the calculation of ΔP and MP. The secondary objectives are: 1) verify whether in patients with a lung parenchyma characterized by greater parenchymal heterogeneity, as assessed by EIT, P1-P2 decay is greater than in patients with greater parenchymal homogeneity; 2) evaluate whether patients with both ΔP values calculated using P1 and P2 <15 cmH2O (or both MP values calculated using P1 and P2 <17 J/min) develop shorter duration of invasive mechanical ventilation, shorter ICU and hospital length of stay and lower ICU and hospital mortality, as compared to patients with only ΔP calculated with P1 ≥ 15 cmH2O (or only MP calculated with P1 ≥ 17 J/min) and patients with both ΔP values calculated using P1 and P2 ≥ 15 cmH2O (or both MP values calculated using P1 and P2 ≥ 17 J/min).
Status | Recruiting |
Enrollment | 1000 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion criteria: - Age greater than 18 years old - Endotracheal intubation or tracheostomy - Controlled mechanical ventilation - Patient able to tolerate a 5-second end-inspiratory and end-expiratory pause with no hemodynamic or respiratory complications and pressure-time waveforms of sufficient quality for interpretation - Inclusion within 48 hours since ICU admission Exclusion criteria: - None (provided the inclusion criteria are satisfied) |
Country | Name | City | State |
---|---|---|---|
Italy | University Hospital of Padua | Padua |
Lead Sponsor | Collaborator |
---|---|
University of Padova |
Italy,
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. — View Citation
Amato MB, Meade MO, Slutsky AS, Brochard L, Costa EL, Schoenfeld DA, Stewart TE, Briel M, Talmor D, Mercat A, Richard JC, Carvalho CR, Brower RG. Driving pressure and survival in the acute respiratory distress syndrome. N Engl J Med. 2015 Feb 19;372(8):747-55. doi: 10.1056/NEJMsa1410639. — View Citation
Barberis L, Manno E, Guerin C. Effect of end-inspiratory pause duration on plateau pressure in mechanically ventilated patients. Intensive Care Med. 2003 Jan;29(1):130-4. doi: 10.1007/s00134-002-1568-z. Epub 2002 Dec 6. — View Citation
Chi Y, Zhao Z, Frerichs I, Long Y, He H. Prevalence and prognosis of respiratory pendelluft phenomenon in mechanically ventilated ICU patients with acute respiratory failure: a retrospective cohort study. Ann Intensive Care. 2022 Mar 5;12(1):22. doi: 10.1186/s13613-022-00995-w. — View Citation
Fan E, Del Sorbo L, Goligher EC, Hodgson CL, Munshi L, Walkey AJ, Adhikari NKJ, Amato MBP, Branson R, Brower RG, Ferguson ND, Gajic O, Gattinoni L, Hess D, Mancebo J, Meade MO, McAuley DF, Pesenti A, Ranieri VM, Rubenfeld GD, Rubin E, Seckel M, Slutsky AS, Talmor D, Thompson BT, Wunsch H, Uleryk E, Brozek J, Brochard LJ; American Thoracic Society, European Society of Intensive Care Medicine, and Society of Critical Care Medicine. An Official American Thoracic Society/European Society of Intensive Care Medicine/Society of Critical Care Medicine Clinical Practice Guideline: Mechanical Ventilation in Adult Patients with Acute Respiratory Distress Syndrome. Am J Respir Crit Care Med. 2017 May 1;195(9):1253-1263. doi: 10.1164/rccm.201703-0548ST. Erratum In: Am J Respir Crit Care Med. 2017 Jun 1;195(11):1540. — View Citation
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Mezidi M, Yonis H, Aublanc M, Lissonde F, Louf-Durier A, Perinel S, Tapponnier R, Richard JC, Guerin C. Effect of end-inspiratory plateau pressure duration on driving pressure. Intensive Care Med. 2017 Apr;43(4):587-589. doi: 10.1007/s00134-016-4651-6. Epub 2016 Dec 20. No abstract available. — View Citation
Protti A, Votta E. Role of tissue viscoelasticity in the pathogenesis of ventilator-induced lung injury. In: Vincent JL, ed. Annual Update in Intensive Care and Emergency Medicine 2018. Springer International Publishing; 2018:193-204.
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* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Comparison among ?P values calculated with end-inspiratory airway pressure measured at different timepoints during a 5-s-end-inspiratory pause: automatic pause of the ventilator, first point of zero flow (P1), 0.5 s, 2 s, 3 s, and 5 s (P2) | Calculation of ?P with end-inspiratory airway pressure measured at different timepoints (automatic pause of the ventilator, first point of zero flow [P1], 0.5 s, 2 s, 3 s, 5 s [P2]) and comparison of the different values | Once per patient within 48 h from ICU admission | |
Primary | Comparison among MP values calculated with end-inspiratory airway pressure measured at different timepoints during a 5-s-end-inspiratory pause: automatic pause of the ventilator, first point of zero flow (P1), 0.5 s, 2 s, 3 s, and 5 s (P2) | Calculation of MP with end-inspiratory airway pressure measured at different timepoints (automatic pause of the ventilator, first point of zero flow [P1], 0.5 s, 2 s, 3 s, 5 s [P2]) and comparison of the different values | Within 2 days from ICU admission | |
Secondary | Comparison among end-inspiratory airway pressures measured at different timepoints: automatic pause of the ventilator, first point of zero flow (P1), 0.5 s, 2 s, 3 s, and 5 s (P2) | Measurement of end-inspiratory airway pressure at different timepoints (automatic pause of the ventilator, first point of zero flow [P1], 0.5 s, 2 s, 3 s, 5 s [P2]) and comparison of the different values | Within 2 days from ICU admission | |
Secondary | Comparison among respiratory system compliance calculated with end-inspiratory airway pressure measured at different timepoints: automatic pause of the ventilator, first point of zero flow (P1), 0.5 s, 2 s, 3 s, and 5 s (P2) | Calculation of respiratory system compliance with end-inspiratory airway pressure measured at different timepoints (automatic pause of the ventilator, first point of zero flow [P1], 0.5 s, 2 s, 3 s, 5 s [P2]) and comparison of the different values | Within 2 days from ICU admission | |
Secondary | Comparison among airway resistance calculated with end-inspiratory airway pressure measured at different timepoints: automatic pause of the ventilator, first point of zero flow (P1), 0.5 s, 2 s, 3 s, and 5 s (P2) | Calculation of airway resistance with end-inspiratory airway pressure measured at different timepoints (automatic pause of the ventilator, first point of zero flow [P1], 0.5 s, 2 s, 3 s, 5 s [P2]) and comparison of the different values | Within 2 days from ICU admission | |
Secondary | Correlation between EIT variables indicating lung parenchymal heterogeneity and the difference between the values of P1 and P2 and the values of ?P (or MP) calculated with P1 and P2 | In the subgroup of patients undergoing EIT, calculation of center of ventilation, global inhomogeneity index, regional ventilation delay, and pendelluft and correlation with P1-P2 decay and the difference between ?P (or MP) measured with P1 and P2 | Within 2 days from ICU admission | |
Secondary | Association between ?P calculated with P1 and P2 and duration of invasive mechanical ventilation | Assess whether those patients ventilated with ?P values calculated using both P1 and P2 < 15 cmH2O develop shorter duration of invasive mechanical ventilation, as compared to patients ventilated with only ?P calculated with P1 = 15 cmH2O and patients ventilated with ?P values calculated using both P1 and P2 = 15 cmH2O | From date of randomization until the date of ICU discharge/death assessed up to 12 months | |
Secondary | Association between ?P calculated with P1 and P2 and 28-day ventilation-free days | Assess whether those patients ventilated with ?P values calculated using both P1 and P2 < 15 cmH2O develop more 28-day ventilation-free days, as compared to patients ventilated with only ?P calculated with P1 = 15 cmH2O and patients ventilated with ?P values calculated using both P1 and P2 = 15 cmH2O | Within 28 days from ICU admission | |
Secondary | Association between ?P calculated with P1 and P2 and lengths of stay | Assess whether those patients ventilated with ?P values calculated using both P1 and P2 < 15 cmH2O develop shorter ICU and hospital length of stay, as compared to patients ventilated with only ?P calculated with P1 = 15 cmH2O and patients ventilated with ?P values calculated using both P1 and P2 = 15 cmH2O | From date of randomization until the date of ICU or hospital discharge/death assessed up to 12 months | |
Secondary | Association between ?P calculated with P1 and P2 and mortality | Assess whether those patients ventilated with ?P values calculated using both P1 and P2 < 15 cmH2O develop lower ICU and hospital mortality, as compared to patients ventilated with only ?P calculated with P1 = 15 cmH2O and patients ventilated with ?P values calculated using both P1 and P2 = 15 cmH2O | From date of randomization until the date of ICU or hospital discharge/death assessed up to 12 months | |
Secondary | Association between MP calculated with P1 and P2 and duration of invasive mechanical ventilation | Assess whether those patients ventilated with MP values calculated using both P1 and P2 < 17 J/min develop shorter duration of invasive mechanical ventilation, as compared to patients ventilated with only MP calculated with P1 = 17 J/min and patients ventilated with MP values calculated using both P1 and P2 = 17 J/min | From date of randomization until the date of ICU discharge/death assessed up to 12 months | |
Secondary | Association between MP calculated with P1 and P2 and 28-day ventilation-free days | Assess whether those patients ventilated with MP values calculated using both P1 and P2 < 17 J/min develop more 28-day ventilation-free days, as compared to patients ventilated with only MP calculated with P1 = 17 J/min and patients ventilated with MP values calculated using both P1 and P2 = 17 J/min | Within 28 days from ICU admission | |
Secondary | Association between MP calculated with P1 and P2 and lengths of stay | Assess whether those patients ventilated with MP values calculated using both P1 and P2 < 17 J/min develop shorter ICU and hospital length of stay, as compared to patients ventilated with only MP calculated with P1 = 17 J/min and patients ventilated with MP values calculated using both P1 and P2 = 17 J/min | From date of randomization until the date of ICU or hospital discharge/death assessed up to 12 months | |
Secondary | Association between MP calculated with P1 and P2 and mortality | Assess whether those patients ventilated with MP values calculated using both P1 and P2 < 17 J/min develop lower ICU and hospital mortality, as compared to patients ventilated with only MP calculated with P1 = 17 J/min and patients ventilated with MP values calculated using both P1 and P2 = 17 J/min | From date of randomization until the date of ICU or hospital discharge/death assessed up to 12 months |
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