Hypoxic Respiratory Failure Clinical Trial
— LUPOOfficial title:
Lung Ultrasound for Diagnosis of Lung Overdistension in Acute Hypoxaemic Respiratory Failure
NCT number | NCT04648657 |
Other study ID # | 0021712 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | February 25, 2021 |
Est. completion date | May 15, 2021 |
Verified date | April 2022 |
Source | University of Padova |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The investigators suppose that lung sliding could be reduced in the same lung region moving from less ventilated to overinflated condition. This is supported by theoretical arguments by some authors but so far it has not been demonstrated. The investigators suppose that speckle tracking applied to LUS is able to demonstrate a reduction or abolition in pleural sliding when lung tissue is overinflated by higher PEEP after lung recruitment maneuver. The overinflation is diagnosed by Electric Impedance Tomography (EIT) and mechanical respiratory measurements (reduction in compliance as ratio between tidal volume over difference between plateau pressure and PEEP) and localized by EIT.
Status | Completed |
Enrollment | 30 |
Est. completion date | May 15, 2021 |
Est. primary completion date | April 30, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age > 18 years - BMI < 35 kg/m2 Exclusion Criteria: - Presence or history of pneumothorax, absence of lung pulse - Pregnancy - Patients with Pressure arterial O2/FiO2 (PaO2/FiO2) < 100 mmHg with at least 5 cmH2O of PEEP - Pacemaker and/or internal cardiac defibrillator - Hemodynamic parameters: systolic blood pressure <100 mmHg and >180 mmHg, or if systolic blood pressure is between 100-180 mmHg on high dose of IV continuous infusion of norepinephrine (>0,2 µg/kg/min), or dobutamine (>5 µg/kg/min ), or dopamine (>5 µg/kg/min), or epinephrine (>0,1 µg/kg/min) - Hemodynamic instability (systolic blood pressure < 70 mmHg, heart rate increase to >140 bpm or decrease to <60 bpm, appearance of cardiac arrhythmias, (peripheral saturation O2 (SpO2) decrease to < 88%) during RM |
Country | Name | City | State |
---|---|---|---|
Italy | Azienda Ospedaliera Università di Padova | Padova |
Lead Sponsor | Collaborator |
---|---|
University of Padova |
Italy,
Adler A, Amyot R, Guardo R, Bates JH, Berthiaume Y. Monitoring changes in lung air and liquid volumes with electrical impedance tomography. J Appl Physiol (1985). 1997 Nov;83(5):1762-7. — View Citation
Bikker IG, Leonhardt S, Reis Miranda D, Bakker J, Gommers D. Bedside measurement of changes in lung impedance to monitor alveolar ventilation in dependent and non-dependent parts by electrical impedance tomography during a positive end-expiratory pressure trial in mechanically ventilated intensive care unit patients. Crit Care. 2010;14(3):R100. doi: 10.1186/cc9036. Epub 2010 May 30. — View Citation
Duclos G, Bobbia X, Markarian T, Muller L, Cheyssac C, Castillon S, Resseguier N, Boussuges A, Volpicelli G, Leone M, Zieleskiewicz L. Speckle tracking quantification of lung sliding for the diagnosis of pneumothorax: a multicentric observational study. Intensive Care Med. 2019 Sep;45(9):1212-1218. doi: 10.1007/s00134-019-05710-1. Epub 2019 Jul 29. — View Citation
Hickling KG. Best compliance during a decremental, but not incremental, positive end-expiratory pressure trial is related to open-lung positive end-expiratory pressure: a mathematical model of acute respiratory distress syndrome lungs. Am J Respir Crit Care Med. 2001 Jan;163(1):69-78. — View Citation
Uematsu M. Speckle tracking echocardiography - Quo Vadis? Circ J. 2015;79(4):735-41. doi: 10.1253/circj.CJ-15-0049. Epub 2015 Mar 13. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | agreement between LUS+Speckle tracking and EIT in diagnosis of lung overdistension | LUS with speckle tracking applied and EIT are able to diagnose lung overdistension in the same lung zone | 5 months | |
Secondary | quantification of lung sliding by speckle tracking at different levels of PEEP | Speckle tracking applied to LUS is able to quantify lung sliding at different PEEP levels | 5 months | |
Secondary | correlation between number of A-lines and lung overdistention | the number of A-lines per clip at different level of PEEP is related to the lung overdistention diagnosed by EIT | 5 months |
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