Clinical trial NCT02064140: Supported Ventilation in ARDS Patients
Official title: Reducing High Respiratory Drive to Facilitate Supported Ventilation in ARDS Patients: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Respiratory Distress Syndrome
Mechanical Ventilation
Tidal Volume
Keywords: ARDS
Mechanical Ventilation
Tidal volume
NMBA
Lead sponsor: University Medical Center Nijmegen
Sponsor class: OTHER
First posted: 2014-02-17
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Feasibility of titrating tidal volume < 6 ml/kg
timeFrame: Within 5 minutes after titration of NMBA
Secondary outcomes:
measure: Respiratory rate
timeFrame: Artefact-free period in the first 15 minutes during different ventilatory modes after titration of NMBA
measure: Diaphragm electrical activity
timeFrame: Artefact-free period in the first 15 minutes during different ventilatory modes after titration of NMBA.
measure: Transpulmonary pressure
timeFrame: Artefact-free period in the first 15 minutes during different ventilatory modes after titration of NMBA.
measure: Transdiaphragmatic pressure
timeFrame: Artefact-free period in the first 15 minutes during different ventilatory modes after titration of NMBA.
measure: Neuroventilatory efficiency
timeFrame: Artefact-free period in the first 15 minutes during different ventilatory modes after titration of NMBA.
measure: Neuromechanical efficiency
timeFrame: Artefact-free period in the first 15 minutes during different ventilatory modes after titration of NMBA.
measure: Patient-ventilator contribution to breathing
timeFrame: During titration of NMBA (each three minutes) and during PS and NAVA after titration NMBA
measure: Oxygenation index
timeFrame: Before start of the study; before titration of NMBA during different ventilatory modes; after titration of NMBA; after an hour for each ventilatory mode.
measure: Carbon dioxide tension in arterial blood (PaCO2)
timeFrame: Before start of the study; before titration of NMBA during different ventilatory modes; after titration of NMBA; after an hour for each ventilatory mode.
measure: pH of arterial blood
timeFrame: Before start of the study; before titration of NMBA during different ventilatory modes; after titration of NMBA; after an hour for each ventilatory mode.
measure: Patient-ventilator interaction
timeFrame: Artefact-free period in the first 15 minutes during different ventilatory modes after titration of NMBA.
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud university medical center
Study officials:
affiliation: University Medical Center Nijmegen
name: L MA Heunks, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: