Effect of End-inspiratory Airway Pressure Measurements on the Risk of VILI in Ventilated Patients

NCT05991258 | Unknown

• 1 other identifier: 5607/AO/22
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Acute Respiratory Failure; Mechanical Ventilation Complication; Ventilator-Induced Lung Injury

Keywords

acute respiratory failure; ventilator-induced lung injury

Outcome Measures

Primary Outcomes (2)

• Comparison among ΔP 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 ΔP 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

• 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 Outcomes (12)

• 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)

  Within 2 days from ICU admission

• 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)

  Within 2 days from ICU admission

• 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)

  Within 2 days from ICU admission

• Correlation between EIT variables indicating lung parenchymal heterogeneity and the difference between the values of P1 and P2 and the values of ΔP (or MP) calculated with P1 and P2

  Within 2 days from ICU admission

• Association between ΔP calculated with P1 and P2 and duration of invasive mechanical ventilation

  From date of randomization until the date of ICU discharge/death assessed up to 12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients undergoing invasive mechanical ventilation with volume-controlled ventilation

You may qualify if:

• 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

Sponsors & Collaborators

• University of Padova: lead

Study Sites (1)

University Hospital of Padua

Padua, 35128, Italy

RECRUITING

Related Publications (11)

• Slutsky AS, Ranieri VM. Ventilator-induced lung injury. N Engl J Med. 2013 Nov 28;369(22):2126-36. doi: 10.1056/NEJMra1208707. No abstract available.

  PMID: 24283226 BACKGROUND

• 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.

  PMID: 10793162 BACKGROUND

• 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.

  PMID: 28459336 BACKGROUND

• 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.

  PMID: 25693014 BACKGROUND

• Gattinoni L, Tonetti T, Cressoni M, Cadringher P, Herrmann P, Moerer O, Protti A, Gotti M, Chiurazzi C, Carlesso E, Chiumello D, Quintel M. Ventilator-related causes of lung injury: the mechanical power. Intensive Care Med. 2016 Oct;42(10):1567-1575. doi: 10.1007/s00134-016-4505-2. Epub 2016 Sep 12.

  PMID: 27620287 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 35246748 BACKGROUND

• 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.

  PMID: 12528034 BACKGROUND

• 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.

  PMID: 27999900 BACKGROUND

• Santini A, Votta E, Protti A, Mezidi M, Guerin C. Driving airway pressure: should we use a static measure to describe a dynamic phenomenon? Intensive Care Med. 2017 Oct;43(10):1544-1545. doi: 10.1007/s00134-017-4850-9. Epub 2017 Jun 1. No abstract available.

  PMID: 28573391 BACKGROUND

• Maltais F, Reissmann H, Navalesi P, Hernandez P, Gursahaney A, Ranieri VM, Sovilj M, Gottfried SB. Comparison of static and dynamic measurements of intrinsic PEEP in mechanically ventilated patients. Am J Respir Crit Care Med. 1994 Nov;150(5 Pt 1):1318-24. doi: 10.1164/ajrccm.150.5.7952559.

  PMID: 7952559 BACKGROUND

MeSH Terms

Conditions

Ventilator-Induced Lung Injury

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Tommaso Pettenuzzo, MD

  Institute of Anesthesiology and Intensive Care, Padua University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tommaso Pettenuzzo, MD

CONTACT

00390498213090; tommaso.pettenuzzo@aopd.veneto.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 1, 2023
• First Posted: August 14, 2023
• Study Start: March 9, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: August 14, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)