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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-12-12

Study Completion Date

2020-07-01

Brief Summary

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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").

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Detailed Description

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Conditions

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ARDS Neuromuscular Blockade

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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NMBAs

No interventions assigned to this group

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No