Volume Support/Assist Control Mode Ventilation and Diaphragmatic Atrophy

Conditions

• Mechanical Ventilation Complication

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

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.
• 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.

Study Details

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

Key Dates

Start date

Mar 4, 2019

Status verified

Jun 2025

Primary completion

May 31, 2027

Completion

May 31, 2027

Study Design

Enrollment

468 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

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).

Primary Outcome Measure

Ventilator-Free Days [ Time Frame: 28 days ]

Central Contacts

• Bhakti Patel, MD
  773-702-0902
  [email protected]
• Anne S Pohlman, MSN
  773-702-3804
  [email protected]

Locations (2)

Find similar trials in Chicago, IL

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