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Volume Support/Assist Control Mode Ventilation and Diaphragmatic Atrophy

A Phase III Randomized Trial Comparing the Effects of Volume Support and Assist Control Mode Ventilation on Ventilator-Free Days and Diaphragmatic Atrophy

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03901924
Enrollment
468
Registered
2019-04-03
Start date
2019-03-04
Completion date
2027-05-01
Last updated
2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mechanical Ventilation Complication

Keywords

Diaphragm Atrophy, Ventilator Induced Diaphragm Dysfunction, Mechanical Ventilation, Volume Support Mode, Assist Control Mode, Diaphragm Thickening Fraction, Intubation, Delirium, Ventilator-Free Days

Brief summary

The objective of the study is to determine how controlled mode ventilation and support mode ventilation impact ventilator-free days and diaphragmatic atrophy.

Detailed description

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.

Interventions

OTHERVolume Support Mode Mechanical Ventilation

This is a spontaneous mode of mechanical ventilation that depends on the patient's efforts. A target volume (6 cc/kg of IBW), PEEP and FiO2 are set by the medical team, and the ventilator varies the inspiratory pressure support with each breath to achieve the target volume. The respiratory rate is fully dependent on the patient. Sedation while on mechanical ventilation will be set at a goal RASS of 0 to -2.

OTHERAssist Control Mode Mechanical Ventilation

This is a controlled mode of mechanical ventilation that is independent of patient's efforts. A tidal volume (6 cc/kg of IBW), respiratory rate, PEEP and FiO2 are set by the medical team. Sedation while on mechanical ventilation will be set at a goal RASS of 0 to -2.

Sponsors

University of Chicago
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Masking description

Investigator and outcomes assessor will be masked to randomization and ventilator settings

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Ventilator-Free Days28 daysA Phase III Primary Outcome; Defined as days alive and free from mechanical ventilation at day 28

Secondary

MeasureTime frameDescription
Rate of Diaphragm AtrophyThrough study completion, an average of 28 daysDefined as percentage decline in diaphragm thickness per day

Countries

United States

Contacts

CONTACTBhakti Patel, MD
bpatel@bsd.uchicago.edu773-702-0902
CONTACTAnne S Pohlman, MSN
apohlman@bsd.uchicago.edu773-702-3804
STUDY_DIRECTORJohn P Kress, MD

University of Chicago

PRINCIPAL_INVESTIGATORBhakti Patel, MD

University of Chicago

PRINCIPAL_INVESTIGATORRoger Struble, MD

University of Iowa

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 14, 2026