Volume Support/Assist Control Mode Ventilation and Diaphragmatic Atrophy

Mechanical Ventilation Complication Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03901924
• Other study ID #: 18-1482
• Status: Recruiting
• Phase: N/A
• Start date: March 4, 2019
• Est. completion date: January 2025

Study information

• Verified date: May 2024
• Source: University of Chicago
• Contact: Bhakti Patel, MD
• Phone: 773-702-0902
• Email: bpatel[@]bsd.uchicago.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 468
• Est. completion date: January 2025
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrophy
• Mechanical Ventilation Complication

Intervention

Other:
• Volume 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.
• Assist 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.

Locations

Country	Name	City	State
United States	The University of Chicago Medical Center	Chicago	Illinois
United States	University of Iowa	Iowa City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

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