Viewing Study NCT06494215



Ignite Creation Date: 2024-07-17 @ 12:01 PM
Last Modification Date: 2024-10-26 @ 3:34 PM
Study NCT ID: NCT06494215
Status: RECRUITING
Last Update Posted: 2024-07-10
First Post: 2024-07-02

Brief Title: Comparison of Different Methods to Calculate Pendelluft by Electrical Impedance Tomography in Mechanically Ventilated Patients
Sponsor: University of Sao Paulo General Hospital
Organization: University of Sao Paulo General Hospital

Study Overview

Official Title: Comparison of Different Methods to Calculate Pendelluft by Electrical Impedance Tomography in Patients Undergoing Invasive Mechanical Ventilation Under Pressure Support Mode
Status: RECRUITING
Status Verified Date: 2024-06
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The Pendelluft phenomenon is an important cause of lung damage in spontaneously breathing mechanically ventilated patients since it considerably increases the stress on the lung parenchyma in the dependent areas It can result in a local driving pressure up to three times higher than the global driving pressure The measurement of Pendelluft is still uncertain in the literature and although various methods have been proposed not all have the same meaning in terms of pulmonary overstress and overstrain This study proposes a comparative analysis of different ways to calculate and estimate the stress imposed on the lung parenchyma by Pendelluft in terms of regional volume and local driving pressure through electrical impedance tomography
Detailed Description: Respiratory mechanics and regional ventilation will be monitored by electrical impedance tomography Enlight 1800 and 2100 Timpel Esophageal and gastric pressures will be obtained by placing an esophagealgastric balloon cathether Nutrivent validation concerning position will be done through modified Baydur maneuver delta esophagealdelta airway pressure 08-12 The hardware Pneumodrive will be used to inflate the balloon and store the airway gastric and esophageal pressures

Initially the patients will be monitored with EIT for aproximately 30 minutes after pletismography stabilization Then an arterial blood-gas sample shall be collected for analysis Next three expiratory and three inspiratory pauses of at least two seconds will be realized with intervals of eight respiratory cycles between them allowing plateau pressure to be recorded and global and regional driving pressure to be estimated All this data will be stored for later analysis The same procedures and measurements shall be made sequentially with a 50 higher pressure support and with a 50 lower pressure support

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None