Acute Respiratory Distress Syndrome Clinical Trial
Official title:
Reducing High Respiratory Drive to Facilitate Supported Ventilation in ARDS Patients: a Pilot Study
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.
Status | Completed |
Enrollment | 12 |
Est. completion date | November 2014 |
Est. primary completion date | November 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Netherlands | Radboud university medical center | Nijmegen |
Lead Sponsor | Collaborator |
---|---|
University Medical Center Nijmegen |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Feasibility of titrating tidal volume < 6 ml/kg | 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). | Within 5 minutes after titration of NMBA | No |
Secondary | Respiratory rate | A secondary outcome measure is the respiratory rate after titration NMBA during different ventilatory modes. | Artefact-free period in the first 15 minutes during different ventilatory modes after titration of NMBA | No |
Secondary | Diaphragm electrical activity | A secondary outcome measure is the root-mean-square of the diaphragm electrical activity after titration NMBA during different ventilatory modes. | Artefact-free period in the first 15 minutes during different ventilatory modes after titration of NMBA. | No |
Secondary | Transpulmonary pressure | 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. | Artefact-free period in the first 15 minutes during different ventilatory modes after titration of NMBA. | No |
Secondary | Transdiaphragmatic pressure | 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. | Artefact-free period in the first 15 minutes during different ventilatory modes after titration of NMBA. | No |
Secondary | Neuroventilatory efficiency | 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. | Artefact-free period in the first 15 minutes during different ventilatory modes after titration of NMBA. | No |
Secondary | Neuromechanical efficiency | 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. | Artefact-free period in the first 15 minutes during different ventilatory modes after titration of NMBA. | No |
Secondary | Patient-ventilator contribution to breathing | 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. | During titration of NMBA (each three minutes) and during PS and NAVA after titration NMBA | No |
Secondary | Oxygenation index | A secondary parameter is the oxygenation index which is determined as the ratio between arterial oxygen tension and fraction of inspired oxygen. | Before start of the study; before titration of NMBA during different ventilatory modes; after titration of NMBA; after an hour for each ventilatory mode. | Yes |
Secondary | Carbon dioxide tension in arterial blood (PaCO2) | A secondary parameter is the carbon dioxide tension in 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. | Yes |
Secondary | pH of arterial blood | A secondary parameter is the 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. | Yes |
Secondary | Patient-ventilator interaction | Patient-ventilator interaction is evaluated using the NeuroSync index during different ventilatory modes. | Artefact-free period in the first 15 minutes during different ventilatory modes after titration of NMBA. | No |
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