Volume Support/Assist Control Mode Ventilation and Diaphragmatic Atrophy

NCT03901924 | Recruiting

• 1 other identifier: 18-1482
• Study Type: interventional
• Target: 468
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Ventilator-Free Days

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

  28 days

Secondary Outcomes (1)

• Rate of Diaphragm Atrophy

  Through study completion, an average of 28 days

Other Outcomes (10)

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

  Through study completion, an average of 28 days

• Noninvasive Measurements of Diaphragm Expiratory Strength

  Through study completion, an average of 28 days

• Diaphragm Thickening Fraction

  Through study completion, an average of 28 days

Study Arms (2)

Volume Support Mode Mechanical Ventilation

ACTIVE COMPARATOR

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).

Other: Volume Support Mode Mechanical Ventilation

Assist Control Mode Mechanical Ventilation

ACTIVE COMPARATOR

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).

Other: Assist Control Mode Mechanical Ventilation

Interventions

Volume Support Mode Mechanical Ventilation OTHER

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.

Volume Support Mode Mechanical Ventilation

Assist Control Mode Mechanical Ventilation OTHER

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.

Assist Control Mode Mechanical Ventilation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (2)

The University of Chicago Medical Center

Chicago, Illinois, 60637, United States

RECRUITING

University of Iowa

Iowa City, Iowa, 52242, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• John P Kress, MD

  University of Chicago

  STUDY DIRECTOR

• Bhakti Patel, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

• Roger Struble, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bhakti Patel, MD

CONTACT

773-702-0902; bpatel@bsd.uchicago.edu

Anne S Pohlman, MSN

CONTACT

773-702-3804; apohlman@bsd.uchicago.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigator and outcomes assessor will be masked to randomization and ventilator settings
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2019
• First Posted: April 3, 2019
• Study Start: March 4, 2019
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: June 6, 2025

Record last verified: 2025-06

Locations

US (2)