Primary Objective: to determine the feasibility of supported MV with low tidal volumes after partial neuromuscular blockade in patients with high respiratory drive. Secondary Objective: to determine the effect of partial neuromuscular blockade on…
ID
Source
Brief title
Condition
- Respiratory tract infections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the ability to titrate rocuronium in order to
decrease the tidal volume (Vt) to approximately 6 ml/kg (yes/no).
Secondary outcome
• Respiratory rate
• Diaphragm activity (Edi)
• Transpulmonary pressure
• Transdiaphragmatic pressure
• Work of breathing
• Dynamic and static respiratory compliance
• Neuroventilatory efficiency (tidal volume/Edi)
• Neuromechanical efficiency (transdiaphragmatic pressure/Edi)
• Patient-ventilator contribution to breathing: PVBC = (tidal volume/Edi,
no-assist) / (tidal volume/Edi, assist)
• Oxygenation index (arterial oxygen tension / fraction of inspired oxygen)
• Patient-ventilator asynchrony
Background 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 asychrony. 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 kan be ventilated with suppported 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 NMBA can decrease
activitiy 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.
Study objective
Primary Objective: to determine the feasibility of supported MV with low tidal
volumes after partial neuromuscular blockade in patients with high respiratory
drive.
Secondary Objective: to determine the effect of partial neuromuscular blockade
on pulmonary mechanics and respiratory muscle function in patients with high
respiratory drive.
Study design
A prospective interventional pilot study.
Intervention
Low dose rocuronium will be administered to decrease respiratory drive until
the patient ventilates with a tidal volume ~6 ml/kg. This will be done in steps
of 5 mg boluses. Ventilator modes will be systematically switched among volume
controlled, pressure support and NAVA ventilation.
Study burden and risks
The burden and risks for the subjects are minimal, because these do not deviate
from those during the routine ICU care.
First, during routine care neuromuscular blockers are given in a dose that
completely supress respiratory muscle activity to allow controlled ventilation
with low tidal volumes. In this study, neuromuscular blocking is titrated to a
level that allows spontaneous breathing, but reduces the risk of high tidal
volumes. Thus, the dose of neuromuscular blocking will never be higher than
during routine clinical care.
Second, different ventilation modes (volume control, pressure support and
neurally adjusted ventilation assist) will be compared during the study, These
modes are also used during routine clinical care in the treatment of ARDS
patients.
In conclusion, the burden and risks for the subjects are not different than
during routine clinical care. In relation to the expected benefits of the study
(preservation of respiratory muscle activity, improved hemodynamics and
oxygenation) this justifies the study protocol.
Geert Grooteplein-Zuid (huispost 710) 10
Nijmegen 6525 GA
NL
Geert Grooteplein-Zuid (huispost 710) 10
Nijmegen 6525 GA
NL
Listed location countries
Age
Inclusion criteria
• age > 18 year
• informed consent
• ARDS according to the Berlin definition
• RASS -4/-5
• tidal volume > 8 ml/kg during supported ventilation
• esophageal EMG catheter with balloons in situ
Exclusion criteria
• recent use of muscle relaxants / neuromuscular blocking agents (< 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 / mean arterial pressure (MAP) < 65 mm Hg
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL46810.091.13 |