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Supported Ventilation in ARDS Patients

U

University Medical Center Nijmegen

Status

Completed

Conditions

Tidal Volume
Acute Respiratory Distress Syndrome
Mechanical Ventilation

Treatments

Drug: Rocuronium

Study type

Interventional

Funder types

Other

Identifiers

NCT02064140
MV NMBA JNLH13

Details and patient eligibility

About

Acute respiratory distress syndrome (ARDS) is characterized by acute bilateral pulmonary infiltrates and impairment of oxygen uptake. For example, pneumonia can cause the development of ARDS. Despite modern intensive care treatment, mortality in ARDS patients remains high (40%). Invasive mechanical ventilation (MV) is the mainstay of ARDS treatment. Controlled MV is the conventional ventilation strategy to ensure lung protective ventilation (low tidal volumes) and recovery of the lungs. However, among disadvantages of controlled MV are the development of respiratory muscle atrophy (due to disuse) and the need for high dose sedatives to prevent patient-ventilator asynchrony. The use of high doses of sedatives and respiratory muscle weakness are associated with increased morbidity, worse clinical outcomes and prolonged MV.

Besides controlled MV, a patient can be ventilated with supported ventilation. Supported MV decreases the likelihood to develop muscle atrophy, improves oxygenation and hemodynamics, and lowers consumption of sedatives. However potential disadvantages of supported ventilation include generation of too high tidal volumes, especially in patients with high respiratory drive. A previous study in healthy subjects has shown that titration of neuromuscular blocking agent (NMBA) can decrease activity of inspiratory muscles, while maintaining adequate ventilation. It is hypothesized that low dose NMBA may enable supported MV with adequate tidal volumes, in patients with high respiratory drive.

Enrollment

12 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • age > 18 year
  • informed consent
  • ARDS according to the Berlin definition
  • RASS -4/-5
  • tidal volume > 8 ml/kg during supported ventilation
  • double balloon esophageal EMG NAVA catheter

Exclusion criteria

  • recent use of muscle relaxants / NMBAs (< 3 hours)
  • pre-existent neuromuscular disease (congenital or acquired) or diseases / disorders know to be associated with myopathy including auto-immune diseases
  • phrenic nerve lesions
  • elevated intracranial pressure or clinical suspicion of elevated intracranial pressure (i.e. neurotrauma)
  • open chest or abdomen
  • pregnancy
  • systolic blood pressure < 90 mm Hg / MAP < 65 mm Hg

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

12 participants in 1 patient group

Neuromuscular blocking agent
Experimental group
Treatment:
Drug: Rocuronium

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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