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Completed

NCT Number: NCT02064140

Supported Ventilation in ARDS Patients

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.

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Key information

Conditions

Acute Respiratory Distress Syndrome Lung Diseases Mechanical Ventilation Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases Tidal Volume

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Radboud university medical center

Nijmegen, 6500HB, Netherlands

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Rocuronium

Drug

Primary outcomes

  1. 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

  1. Respiratory rate

    Time frame: Artefact-free period in the first 15 minutes during different ventilatory modes after titration of NMBA

    A secondary outcome measure is the respiratory rate after titration NMBA during different ventilatory modes.

  2. Diaphragm electrical activity

    Time frame: Artefact-free period in the first 15 minutes during different ventilatory modes after titration of NMBA.

    A secondary outcome measure is the root-mean-square of the diaphragm electrical activity after titration NMBA during different ventilatory modes.

  3. Transpulmonary pressure

    Time frame: Artefact-free period in the first 15 minutes during different ventilatory modes after titration of NMBA.

    Transpulmonary pressure is determined as the difference between mouth pressure and esophageal pressure during inspiration. Breath-by-breath data are ensemble-averaged over the first 2 minutes after titration NMBA during different ventilatory modes.

  4. Transdiaphragmatic pressure

    Time frame: Artefact-free period in the first 15 minutes during different ventilatory modes after titration of NMBA.

    Transdiaphragmatic pressure is determined as the difference between gastric pressure and esophageal pressure during inspiration. Breath-by-breath data are ensemble-averaged over the first two minutes after titration NMBA during different ventilatory modes.

  5. Neuroventilatory efficiency

    Time frame: Artefact-free period in the first 15 minutes during different ventilatory modes after titration of NMBA.

    A secondary outcome measure is the neuroventilatory efficiency (i.e. the ratio of diaphragm electrical activity and tidal volume) after titration NMBA during different ventilatory modes.

  6. Neuromechanical efficiency

    Time frame: Artefact-free period in the first 15 minutes during different ventilatory modes after titration of NMBA.

    A secondary outcome measure is the neuromechanical efficiency (i.e. the ratio of diaphragm electrical activity and transdiaphragmatic pressure) of the diaphragm after titration NMBA during different ventilatory modes.

  7. Patient-ventilator contribution to breathing

    Time frame: During titration of NMBA (each three minutes) and during PS and NAVA after titration NMBA

    A secondary outcome measure is the patient-ventilator contribution to breathing (i.e. ratio of: the ratio of tidal volume and diaphragm electrical activity without assist, and the ratio of tidal volume and diaphragm electrical acticity with assist) during and after titration of NMBA.

  8. Oxygenation index

    Time frame: Before start of the study; before titration of NMBA during different ventilatory modes; after titration of NMBA; after an hour for each ventilatory mode.

    A secondary parameter is the oxygenation index which is determined as the ratio between arterial oxygen tension and fraction of inspired oxygen.

  9. Carbon dioxide tension in arterial blood (PaCO2)

    Time frame: Before start of the study; before titration of NMBA during different ventilatory modes; after titration of NMBA; after an hour for each ventilatory mode.

    A secondary parameter is the carbon dioxide tension in arterial blood.

  10. pH of arterial blood

    Time frame: Before start of the study; before titration of NMBA during different ventilatory modes; after titration of NMBA; after an hour for each ventilatory mode.

    A secondary parameter is the pH of arterial blood.

  11. Patient-ventilator interaction

    Time frame: Artefact-free period in the first 15 minutes during different ventilatory modes after titration of NMBA.

    Patient-ventilator interaction is evaluated using the NeuroSync index during different ventilatory modes.

Sponsors and collaborators

Lead sponsor

University Medical Center Nijmegen

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Feb 17, 2014
Registry last updated
Dec 2, 2014

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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