Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06409897
Status:
RECRUITING
Last Update Posted:
2024-05-10
First Post:
2024-04-24
Brief Title:
Respiratory Mechanics Assessment at Different Head of the Bed Elevations in Mechanically Ventilated Patients
Sponsor:
University of Sao Paulo General Hospital
Organization:
University of Sao Paulo General Hospital
Study Overview
Official Title:
Respiratory Mechanics Assessment at Different Head of the Bed Elevations in Mechanically Ventilated Patients
Status:
RECRUITING
Status Verified Date:
2024-04
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 effects of different degrees of head-of-bed elevation on respiratory mechanics are poorly explored in the literature and no study has investigated such effects using electrical impedance tomography esophageal and gastric balloons to identify the ideal angle for optimizing respiratory mechanics The hypothesis is that there is a optimal degree for the respiratory mechanics
Detailed Description:
Respiratory mechanics and regional ventilation will be monitored using electrical impedance tomography Enlight 2100 Timpel Medical Brazil Esophageal and gastric pressures will be obtained through esophageal and gastric balloon catheters Nutrivent validation concerning to modified Baydur maneuver - slope delta esophageal pressuredelta airway pressure 08-12 We are using the hardware Pneumodrive Biônica Recife Brazil to record and store the esophageal gastric and airway pressures these data will be analyzed using LabVIEW 71 Pneumobench
Initially patients will be positioned at 0 degrees of head-of-bed elevation and after stabilization of the plethysmogram data from electrical impedance tomography hemodynamics and arterial blood gas will be collected arterial blood will be drawn by a nurse or physician Sequentially and in the same manner the bed will be adjusted to 10 20 30 and 40 degrees the same data will be collected except for the arterial blood sample which will only be collected at the 40-degree elevation Then an alveolar recruitment maneuver will be performed followed by a PEEP titration with 10-degree of head-of-bed elevation
Initially patients will be positioned at 0 degrees of head-of-bed elevation and after stabilization of the plethysmogram data from electrical impedance tomography hemodynamics and arterial blood gas will be collected arterial blood will be drawn by a nurse or physician Sequentially and in the same manner the bed will be adjusted to 10 20 30 and 40 degrees the same data will be collected except for the arterial blood sample which will only be collected at the 40-degree elevation Then an alveolar recruitment maneuver will be performed followed by a PEEP titration with 10-degree of head-of-bed elevation
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