RecruitingNot ApplicableNCT03901924

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

Sponsor

University of Chicago

Enrollment

468 participants

Start Date

Mar 4, 2019

Study Type

INTERVENTIONAL

Conditions

Mechanical Ventilation Complication

Summary

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

Eligibility

Min Age: 18 Years

Inclusion Criteria1

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 Criteria9

pregnancy
cardiopulmonary arrest
history of diaphragmatic paralysis or neuromuscular disease
chronic obstructive pulmonary disease (COPD) or asthma exacerbation with evidence of auto-PEEPing requiring intubation
neuromuscular blockade
expectation to be liberated from ventilator in < 24 hours
history of mechanical ventilation in the last 6 months
presence of tracheostomy
high cervical spine injury

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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.