Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2025-12-26 @ 12:01 AM
Study NCT ID:
NCT04996394
Status:
COMPLETED
Last Update Posted:
2023-05-26
First Post:
2021-04-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
"Effects of Neuromuscular Blocking Agents on End Expiratory Lung Volume During Moderate-severe ARDS"
Sponsor:
University of Milano Bicocca
Organization:
Study Overview
Official Title:
Effects of Neuromuscular Blocking Agents on End Expiratory Lung Volume During Moderate-severe ARDS
Status:
COMPLETED
Status Verified Date:
2023-05
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:
EIT_CURARO
Brief Summary:
This is a monocentric, prospective, observational study that will be conducted in the general ICU of San Gerardo Hospital (Monza, Italy). Study protocol will be started when NMBAs infusion will be stopped for clinical reason until regain of spontaneous breathing activity.
Patients will be enrolled at the moment of NMBAs infusion interruption ("baseline" phase). Clinical data will be collected: hemodynamics, ventilation parameters and respiratory mechanics, arterial blood gas analysis, drugs used for sedation and their dosages. An EIT belt will be positioned around the patient's chest when clinical signs of spontaneous breathing activity will be detectable (unstable flow curve on the ventilator, deflection in airway pressure during an expiratory pause). In this phase ("NMBA interruption") same clinical data will be collected as at baseline. Patients will be ventilated in the same ventilation mode as before (Volume Controlled mechanical ventilation), but the inspiratory trigger on the ventilator will be turned on to reduce patient-ventilator asynchronies. When an EIT trace lasting at least 10 minutes will be recorded, an NMBA bolus (as prescribed by the treating physician) will be administered and a continuous infusion will be restarted. Clinical data will be collected again in this phase ("NMBA restart").
Patients will be enrolled at the moment of NMBAs infusion interruption ("baseline" phase). Clinical data will be collected: hemodynamics, ventilation parameters and respiratory mechanics, arterial blood gas analysis, drugs used for sedation and their dosages. An EIT belt will be positioned around the patient's chest when clinical signs of spontaneous breathing activity will be detectable (unstable flow curve on the ventilator, deflection in airway pressure during an expiratory pause). In this phase ("NMBA interruption") same clinical data will be collected as at baseline. Patients will be ventilated in the same ventilation mode as before (Volume Controlled mechanical ventilation), but the inspiratory trigger on the ventilator will be turned on to reduce patient-ventilator asynchronies. When an EIT trace lasting at least 10 minutes will be recorded, an NMBA bolus (as prescribed by the treating physician) will be administered and a continuous infusion will be restarted. Clinical data will be collected again in this phase ("NMBA restart").
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: