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OpenTrials
Completed

NCT Number: NCT04996394

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

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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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

ASST Monza

Monza, Lombardy, 20900, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  1. End Expiratory Lung Volume

    Time frame: 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").

Sponsors and collaborators

Lead sponsor

University of Milano Bicocca

Other

Registry information

Official study title

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

Acronym: EIT_CURARO

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 9, 2021
Registry last updated
May 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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