CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 15 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04996394
NCT04996394N/ACompleted

Effects of Neuromuscular Blocking Agents on End Expiratory Lung Volume During Moderate-severe ARDS

University of Milano Bicocca·observational·Posted Aug 9, 2021·Updated May 26, 2023

In Brief

An observational study for ARDS and Neuromuscular Blockade. Completed, enrolled 15 participants across 1 site.

Detailed 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 Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesItaly
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedAug 9, 2021
Enrollment StartDec 12, 2019
Primary CompletionJul 1, 2020
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 4.9 years ago