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Mechanical Ventilation

Mechanical Ventilation Modes for Preventing Muscle Wasting

N/A

Recruiting

Led By John P Kress, MD

Research Sponsored by University of Chicago

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

history of diaphragmatic paralysis or neuromuscular disease

neuromuscular blockade

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 month, 3 months, and 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare two different types of ventilator support to see which one better preserves patients' ability to breathe on their own and prevents muscle wasting.

Who is the study for?

This trial is for adults over 18 who've been on a mechanical ventilator for less than 36 hours. It's not suitable for those with recent cardiac arrest, high spinal injuries, past ventilation within six months, pregnancy, muscle paralysis drugs in use, diaphragm issues or neuromuscular diseases, tracheostomies, expected quick weaning from the ventilator or severe COPD/asthma.

What is being tested?

The study aims to compare two types of mechanical ventilation: Assist Control Mode and Volume Support Mode. The focus is on their effects on reducing time spent on a ventilator and preventing weakening of the diaphragm muscle due to prolonged use of these machines.

What are the potential side effects?

Potential side effects may include discomfort from the breathing tube or machine settings adjustments. There could also be risks associated with prolonged ventilation like lung infections (pneumonia), injury to vocal cords or lungs, and possible increased weakness in breathing muscles.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of muscle disease or diaphragm paralysis.

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I have not used muscle relaxants recently.

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I have severe COPD or asthma that needed a breathing tube due to worsening symptoms.

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I have never had a cardiopulmonary arrest.

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I have a severe injury in the upper part of my spine.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 month, 3 months, and 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 month, 3 months, and 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month, 3 months, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Ventilator-Free Days

Secondary study objectives

Rate of Diaphragm Atrophy

Other study objectives

Death in Hospital

Death in ICU

Diaphragm Thickening Fraction

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Volume Support Mode Mechanical VentilationActive Control1 Intervention

Volume support mode ventilation is a spontaneous mode where a target goal volume is set on the ventilator. This ventilatory strategy is dependent on patients spontaneously breathing and triggering (or activating) the ventilator to support the breath. The ventilator adjusts the amount of pressure support to deliver with each breath (i.e. if the patient's tidal volume is greater than the set target volume, then the ventilator will decrease the amount of pressure support in the subsequent breath to try to achieve the goal volume and vice versa). The respiratory rate is not set in this mode of ventilation and is dependent on the patient. For patients randomized to this mode, the goal tidal volume will be set at 6 cc/kg of ideal body weight (IBW).

Group II: Assist Control Mode Mechanical VentilationActive Control1 Intervention

In assist control mode ventilation, the machine is programmed to deliver a set tidal volume and set respiratory rate. Patients can breathe over the set respiratory rate, but the volume of breath that they receive is fixed and delivered by the ventilator. For patients randomized to this mode, the tidal volume will be set at 6 cc/kg of ideal body weight (IBW).

0 / 5Eligibility criteria met