Recruiting
Phase 2

APRV vs. AC/VC

Sponsor:

Intermountain Health Care, Inc.

Code:

NCT01339533

Conditions

Respiratory Failure

Acute Lung Injury (ALI)

Acute Respiratory Distress Syndrome (ARDS)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Mechanical Ventilation

Study Details

Brief summary:

APRV mode of ventilation will result in an improved partial pressure of arterial oxygenation/ fraction of inspired oxygen (P/F ratio) on day 3 of mechanical ventilation. Sub hypotheses: APRV will be associated with a reduced amount of sedation used during the ICU stay in patients with respiratory failure. APRV will be associated with a reduction in the amount of vasoactive medication used for blood pressure support in patients with respiratory failure.

Conditions

Respiratory Failure

Acute Lung Injury (ALI)

Acute Respiratory Distress Syndrome (ARDS)

Study ID

NCT01339533

Start date

Oct, 2011

Status verified date

Aug, 2015

Completion date

Jun, 2016

Anticipated

Primary completion date

Dec, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Hypoxemic respiratory failure requiring mechanical ventilation for >24 hours.

Exclusion Criteria:

  • Age under 18
  • Severe chronic obstructive lung disease
  • Patients in whom the only indication for mechanical ventilation is airway protection from poor neurological status.

Study Design

Enrollment

246 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: APRV ls

APRV low stretch will titrate Plow to maintain release volumes between 4 and 8 cc/kg.

active comparator: AC/VC Conventional Ventilation

Standard volume control ventilation with the ARDS Net protocol.

experimental: APRV h

APRV Habashi protocol which sets Plow equal to 0.

Interventions

Mechanical Ventilation

Patients who experience problems breathing and require assistance in breathing are placed on a machine that delivers air to the lungs through a tube through the vocal cords. This study is testing 3 protocols for that machine.

Primary outcome measure

  • P/F Ratio on Day 3 of Mechanical Ventilation [ Time Frame: Day 3 ]

Central Contacts and Locations

Central contacts

Eliotte Hirshberg, MD

801-232-9120ellie.hirshberg@imail.org

Locations

Intermountain Medical Center

Recruiting

Murray, Utah, United States, 84157

Principal Investigator:

Eliotte Hirshberg, MD

LDS Hospital

Recruiting

Salt Lake City, Utah, United States, 84143

More Information

Sponsor

Intermountain Health Care, Inc.

Last update posted

Aug 26, 2015

Last verified

Aug, 2015

Keywords

  • ALI
  • ARDS

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-25. This information was provided to ClinicalTrials.gov by Intermountain Health Care, Inc. on 2015-08-26. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.