Description Module

Description Module

The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.

Description Module path is as follows:

Study -> Protocol Section -> Description Module

Description Module


Ignite Creation Date: 2025-12-25 @ 1:43 AM
Ignite Modification Date: 2025-12-25 @ 1:43 AM
NCT ID: NCT04996394
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").
Study: NCT04996394
Study Brief:
Protocol Section: NCT04996394