CLINICAL TRIAL / NCT03901924
Volume Support/Assist Control Mode Ventilation and Diaphragmatic Atrophy
- Interventional
- Recruiting
- NCT03901924
Contact Information
A Phase III Randomized Trial Comparing the Effects of Volume Support and Assist Control Mode Ventilation on Ventilator-Free Days and Diaphragmatic Atrophy
The objective of the study is to determine how controlled mode ventilation and support mode ventilation impact ventilator-free days and diaphragmatic atrophy.
Ventilator-induced diaphragmatic dysfunction (VIDD) is characterized by diaphragmatic
atrophy and weakness leading to an inability to liberate from the ventilator. Patients
with VIDD have increased intensive care unit and hospital length of stay, higher
reintubation rates, and need for tracheostomy. There are two commonly used modes of
ventilation in the ICU - controlled and support mode ventilation. Conventional practice
is to initiate mechanical ventilation with controlled mode followed by a support mode to
facilitate weaning and eventual extubation. However, this approach may induce
irreversible diaphragmatic atrophy. Observational studies suggest that controlled
ventilation is associated with higher rates of diaphragmatic atrophy than support modes
of ventilation. Diaphragmatic atrophy occurs within the first 24 hours of mechanical
ventilation. To date, it remains unknown whether early initiation of support mode
ventilation prevents VIDD and its associated complications in comparison to controlled
mode ventilation.
The investigators hypothesize that by initiating subjects on support mode ventilation, an
associated increase in ventilator-free days will be seen in comparison to subjects on
controlled mode ventilation. Subjects on support mode ventilation will have less
diaphragmatic atrophy and weakness than subjects on controlled mode ventilation. To
investigate this hypothesis,investigators are conducting a phase III randomized trial
examining the effects of volume support mode versus assist control mode ventilation on
ventilator-free days and rate of diaphragm atrophy.
enrolled subjects requiring mechanical ventilation will be randomized to either volume
support mode or assist control mode within 24 hours of mechanical ventilation initiation.
Diaphragm thickness will be measured by ultrasound daily and subsequently diaphragm
atrophy rate will be calculated in each arm. The operator acquiring ultrasound images
will be blinded to the ventilator mode that the subject was randomized to. Subjects in
the study will follow standard ICU sedation awakening trials and spontaneous breathing
trials. The medical team in charge of the subject will determine when the subject will be
liberated from the ventilator.
There will be up to a 24 hour period from initiation of standard, non-study mechanical
ventilation during which the subject can be consented and enrolled. This will allow the
research team time to contact the subject and/or family in order to obtain informed
consent. Once randomized, all subjects will be initiated on study mode of ventilation.
The medical team will direct other aspects of care.
The phase III trial will be powered to determine if there is a statistically significant
difference in rate of diaphragm atrophy and ventilator-free days between volume support
mode and assist control mode.
Gender
All
Age Group
18 Years and up
Accepting Healthy Volunteers
No
Inclusion Criteria:
subjects > 18 years of age that have been intubated and mechanically ventilated for < 36
hours at the time of screening will be eligible for enrollment
Exclusion Criteria:
1. pregnancy
2. cardiopulmonary arrest
3. history of diaphragmatic paralysis or neuromuscular disease
4. chronic obstructive pulmonary disease (COPD) or asthma exacerbation with evidence of
auto-PEEPing requiring intubation
5. neuromuscular blockade
6. expectation to be liberated from ventilator in < 24 hours
7. history of mechanical ventilation in the last 6 months
8. presence of tracheostomy
9. high cervical spine injury