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Clinical Trials/NCT02064140
NCT02064140
Completed
Not Applicable

Reducing High Respiratory Drive to Facilitate Supported Ventilation in ARDS Patients: a Pilot Study

University Medical Center Nijmegen1 site in 1 country12 target enrollmentFebruary 2014

Overview

Phase
Not Applicable
Intervention
Rocuronium
Conditions
Acute Respiratory Distress Syndrome
Sponsor
University Medical Center Nijmegen
Enrollment
12
Locations
1
Primary Endpoint
Feasibility of titrating tidal volume < 6 ml/kg
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
February 2014
End Date
November 2014
Last Updated
11 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
University Medical Center Nijmegen
Responsible Party
Principal Investigator
Principal Investigator

Leo Heunks

L. Heunks, MD PhD

University Medical Center Nijmegen

Eligibility Criteria

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

Arms & Interventions

Neuromuscular blocking agent

Intervention: Rocuronium

Outcomes

Primary Outcomes

Feasibility of titrating tidal volume < 6 ml/kg

Time Frame: Within 5 minutes after titration of NMBA

The feasibility of titrating tidal volume in ARDS patients below 6 ml/kg using NMBA is evaluated in every patient. The outcome measure is dichotomic (yes/no).

Secondary Outcomes

  • Respiratory rate(Artefact-free period in the first 15 minutes during different ventilatory modes after titration of NMBA)
  • Diaphragm electrical activity(Artefact-free period in the first 15 minutes during different ventilatory modes after titration of NMBA.)
  • Transpulmonary pressure(Artefact-free period in the first 15 minutes during different ventilatory modes after titration of NMBA.)
  • Transdiaphragmatic pressure(Artefact-free period in the first 15 minutes during different ventilatory modes after titration of NMBA.)
  • Neuroventilatory efficiency(Artefact-free period in the first 15 minutes during different ventilatory modes after titration of NMBA.)
  • Neuromechanical efficiency(Artefact-free period in the first 15 minutes during different ventilatory modes after titration of NMBA.)
  • Patient-ventilator contribution to breathing(During titration of NMBA (each three minutes) and during PS and NAVA after titration NMBA)
  • Oxygenation index(Before start of the study; before titration of NMBA during different ventilatory modes; after titration of NMBA; after an hour for each ventilatory mode.)
  • Carbon dioxide tension in arterial blood (PaCO2)(Before start of the study; before titration of NMBA during different ventilatory modes; after titration of NMBA; after an hour for each ventilatory mode.)
  • pH of arterial blood(Before start of the study; before titration of NMBA during different ventilatory modes; after titration of NMBA; after an hour for each ventilatory mode.)
  • Patient-ventilator interaction(Artefact-free period in the first 15 minutes during different ventilatory modes after titration of NMBA.)

Study Sites (1)

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