Volume Support/Assist Control Mode Ventilation and Diaphragmatic Atrophy

ConditionMechanical Ventilation Complication

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorUniversity of Chicago

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Volume Support Mode Mechanical Ventilation
Other intervention
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.
Assist Control Mode Mechanical Ventilation
Other intervention
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.

Treatment groups

468 Participants

are divided into 2 treatment groups

Group A: Volume Support Mode Mechanical VentilationActive comparator 1 intervention

Group B: Assist Control Mode Mechanical VentilationActive comparator 1 intervention

Trial outcomes

Primary outcomes

Ventilator-Free Days

A Phase III Primary Outcome; Defined as days alive and free from mechanical ventilation at day 28

Time frame

28 days

Secondary outcomes

Rate of Diaphragm Atrophy

Defined as percentage decline in diaphragm thickness per day

Time frame

Through study completion, an average of 28 days

Other outcomes

Noninvasive Measurements of Diaphragm Inspiratory Strength 3.+ 9+ Noninvasive Measurements of Diaphragm Function

negative inspiratory force (nif)--measured unit cm H2O

Time frame

Through study completion, an average of 28 days

Noninvasive Measurements of Diaphragm Expiratory Strength

positive expiratory force (pef)--measured unit cm H2O

Time frame

Through study completion, an average of 28 days

Diaphragm Thickening Fraction

(diaphragm thickness at end expiration - diaphragm thickness at end inspiration)/diaphragm thickness at end expiration; measured by ultrasound

Time frame

Through study completion, an average of 28 days

Duration of Mechanical Ventilation

Days on mechanical ventilation

Time frame

28 days

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Chicago

Lead sponsor

Source ClinicalTrials.gov

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