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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month, 3 months, and 12 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Ventilator-Free Days
Secondary outcome measures
Rate of Diaphragm Atrophy
Other outcome measures
Death in Hospital
Death in ICU
Diaphragm Thickening Fraction
+7 moreTrial 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).
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Who is running the clinical trial?
University of ChicagoLead Sponsor
1,004 Previous Clinical Trials
819,309 Total Patients Enrolled
John P Kress, MDPrincipal InvestigatorUniversity of Chicago
8 Previous Clinical Trials
1,682 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are pregnant.I have a history of muscle disease or diaphragm paralysis.I have not used muscle relaxants recently.You have a surgical opening in your throat called a tracheostomy.You are expected to be taken off the ventilator within 24 hours.I have severe COPD or asthma that needed a breathing tube due to worsening symptoms.I am over 18 and have been on a ventilator for less than 36 hours.I have never had a cardiopulmonary arrest.I have a severe injury in the upper part of my spine.
Research Study Groups:
This trial has the following groups:- Group 1: Volume Support Mode Mechanical Ventilation
- Group 2: Assist Control Mode Mechanical Ventilation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals are participating in this medical trial?
"Affirmative. According to clinicaltrials.gov, this research is currently in search of participants and was initially posted on March 4th 2019. The most recent edition of the study's information occurred on July 22nd 2022 and it requires 468 patients at a single site."
Answered by AI
Is this research effort recruiting participants?
"This clinical trial is currently recruiting participants, with the original posting occurring on March 4th 2019. The last recorded update was July 22nd 2022."
Answered by AI
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