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

Completed

• Conditions: ARDS; Neuromuscular Blockade

• Registration Number: NCT04996394
• Lead Sponsor: University of Milano Bicocca

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").

Detailed Description

Not available

Study Timeline

• Study Start: 2019-12-12
• Primary Completion: 2020-07-01
• Study Completion: 2020-07-01
• Study First Submitted: 2021-04-03
• Study First Submitted QC: 2021-08-06
• Study First Posted: 2021-08-09
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-25
• Last Update Posted: 2023-05-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Patients with moderate-severe ARDS (according to Berlin definition)
• Patients treated with NMBAs
• age>18 years old

Exclusion Criteria

• pregnancy,
• presence of air leaks (ex. presence of broncho-pleural fistula or pneumothorax)
• presence of contraindications to EIT belt positioning ( ex. presence of pace-makers, presence of unstable spinal fractures).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
End Expiratory Lung Volume	Entire study duration (approx. 1 year)	Patients will be enrolled at the moment of NMBAs infusion interruption ("baseline" phase). 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. 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").

Trial Locations

Locations (1)

ASST Monza; 🇮🇹 Monza, Lombardia, Italy