Recruiting

Volume Support

Sponsor:

University of Chicago

Code:

NCT03901924

Conditions

Mechanical Ventilation Complication

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Volume Support Mode Mechanical Ventilation

Assist Control Mode Mechanical Ventilation

Study Details

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

Study ID

NCT03901924

Start date

Mar 4, 2019

Status verified date

Jul, 2026

Completion date

May, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

468 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Volume Support Mode Mechanical Ventilation

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).

active comparator: Assist Control Mode Mechanical Ventilation

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).

Interventions

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.

Primary outcome measure

  • Ventilator-Free Days [ Time Frame: 28 days ]

Central Contacts and Locations

Central contacts

Bhakti Patel, MD

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

Anne S Pohlman, MSN

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

Locations

The University of Chicago Medical Center

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Bhakti Patel, MD

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

Anne S Pohlman, MSN

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

More Information

Sponsor

University of Chicago

Last update posted

Jul 13, 2026

Last verified

Jul, 2026

Keywords

  • Diaphragm Atrophy
  • Ventilator Induced Diaphragm Dysfunction
  • Mechanical Ventilation
  • Volume Support Mode
  • Assist Control Mode
  • Diaphragm Thickening Fraction
  • Intubation
  • Delirium
  • Ventilator-Free Days

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Chicago on 2026-07-13.