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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04996394

Acronym

EIT_CURARO

Enrollment

Registered

2021-08-09

Start date

2019-12-12

Completion date

2020-07-01

Last updated

2023-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ARDS, Neuromuscular Blockade

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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

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).

Design outcomes

Primary

Measure	Time frame	Description
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).

Countries

Italy

Outcome results