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Volume Support/Assist Control Mode Ventilation and Diaphragmatic Atrophy

Primary Purpose

Mechanical Ventilation Complication

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Volume Support Mode Mechanical Ventilation
Assist Control Mode Mechanical Ventilation
Sponsored by
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mechanical Ventilation Complication focused on measuring Diaphragm Atrophy, Ventilator Induced Diaphragm Dysfunction, Mechanical Ventilation, Volume Support Mode, Assist Control Mode, Diaphragm Thickening Fraction, Intubation, Delirium, Ventilator-Free Days

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The University of Chicago Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Volume Support Mode Mechanical Ventilation

Assist Control Mode Mechanical Ventilation

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Rate of Diaphragm Atrophy
Defined as percentage decline in diaphragm thickness per day

Full Information

First Posted
February 27, 2019
Last Updated
May 8, 2023
Sponsor
University of Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT03901924
Brief Title
Volume Support/Assist Control Mode Ventilation and Diaphragmatic Atrophy
Official Title
A Phase III Randomized Trial Comparing the Effects of Volume Support and Assist Control Mode Ventilation on Ventilator-Free Days and Diaphragmatic Atrophy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 4, 2019 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Masking Description
Investigator and outcomes assessor will be masked to randomization and ventilator settings
Allocation
Randomized
Enrollment
468 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Volume Support Mode Mechanical Ventilation
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Assist Control Mode Mechanical Ventilation
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Volume Support Mode Mechanical Ventilation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Assist Control Mode Mechanical Ventilation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Ventilator-Free Days
Description
A Phase III Primary Outcome; Defined as days alive and free from mechanical ventilation at day 28
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Rate of Diaphragm Atrophy
Description
Defined as percentage decline in diaphragm thickness per day
Time Frame
Through study completion, an average of 28 days
Other Pre-specified Outcome Measures:
Title
Noninvasive Measurements of Diaphragm Inspiratory Strength 3.+ 9+ Noninvasive Measurements of Diaphragm Function
Description
negative inspiratory force (nif)--measured unit cm H2O
Time Frame
Through study completion, an average of 28 days
Title
Noninvasive Measurements of Diaphragm Expiratory Strength
Description
positive expiratory force (pef)--measured unit cm H2O
Time Frame
Through study completion, an average of 28 days
Title
Diaphragm Thickening Fraction
Description
(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
Title
Duration of Mechanical Ventilation
Description
Days on mechanical ventilation
Time Frame
28 days
Title
Frequency of Ventilator-Related Complications
Description
Including the Following: -reintubation tracheostomy mechanical ventilation > 14 days patients with delirium
Time Frame
Through study completion, an average of 28 days
Title
Readmission to ICU During Same Hospital Admission
Description
Bivariate outcome regarding readmission to ICU--"Yes or No"
Time Frame
Through study completion, an average of 28 days
Title
Death in ICU
Description
Death that occurs while in the ICU
Time Frame
90 days
Title
Death in Hospital
Description
Death that occurs while in the Hospital
Time Frame
90 days
Title
Discharge Destination
Description
i.e. home, long term assisted care, skilled nursing facility, death
Time Frame
90 days
Title
Mortality
Description
measured at 28 days, 90 days, and 1 year
Time Frame
1 month, 3 months, and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
John P Kress, MD
Phone
773-702-6404
Email
jkress@medicine.bsd.uchicago.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Anne S Pohlman, MSN
Phone
773-702-3804
Email
apohlman@medicine.bsd.uchicago.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John P Kress, MD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John P Kress, MD
Phone
773-702-6404
Email
jkress@medicine.bsd.uchicago.edu

12. IPD Sharing Statement

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Volume Support/Assist Control Mode Ventilation and Diaphragmatic Atrophy

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