Lung Ultrasound, PEEP and Overdistension (LUPO)

NCT04648657 | Completed

• 1 other identifier: 0021712
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypoxic Respiratory Failure

Keywords

lung ultrasound; lung overdistention; electric impedance tomography

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• quantification of lung sliding by speckle tracking at different levels of PEEP

  5 months

• correlation between number of A-lines and lung overdistention

  5 months

Study Arms (1)

acute hypoxemic respiratory failure patients

Mechanically ventilated patients with acute hypoxemic respiratory failure (AHRF) with P/F ratio \< 300 with at least PEEP 5 cmH2O)

Device: Lung Ultrasound; Device: Electric impedance tomography

Interventions

Lung Ultrasound DEVICE

Echography of Lungs based on artifacts study

Also known as: LUS

acute hypoxemic respiratory failure patients

Electric impedance tomography DEVICE

Low alternating electrical currents (usually \<5 milliampere at 50-80 kHz) applied through different pair of electrodes on thorax

Also known as: EIT

acute hypoxemic respiratory failure patients

Eligibility Criteria

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

Study Population

Mechanically ventilated patients with acute hypoxemic respiratory failure (AHRF) or acute respiratory distress syndrome (ARDS) according to the Berlin definition (P/F ratio 100-300 with at least PEEP 5 cmH2O)

You may qualify if:

• Age \> 18 years
• BMI \< 35 kg/m2

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Padova: lead

Study Sites (1)

Azienda Ospedaliera Università di Padova

Padua, 35100, Italy

Location

Related Publications (5)

• 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.

  PMID: 20509966 BACKGROUND

• 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.

  PMID: 31359081 BACKGROUND

• 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.

  PMID: 25766514 BACKGROUND

• 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. doi: 10.1164/ajrccm.163.1.9905084.

  PMID: 11208628 BACKGROUND

• 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. doi: 10.1152/jappl.1997.83.5.1762.

  PMID: 9375349 BACKGROUND

Study Officials

• Paolo Navalesi, MD

  University of Padova

  STUDY CHAIR

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: November 23, 2020
• First Posted: December 1, 2020
• Study Start: February 25, 2021
• Primary Completion: April 30, 2021
• Study Completion: May 15, 2021
• Last Updated: April 26, 2022

Record last verified: 2022-04

Locations

IT (1)