Assessing the Role of Inclined Positioning in Acute Respiratory Distress Syndrome Patients Recovery (ARISE)

Peter Morris

Status: Completed

Conditions: ARDS, Human

Treatments: Procedure: upright bed

Study type: Interventional

Funder types: Other

Identifiers

NCT04612608

60328

Details and patient eligibility

About

The purpose of this study is to determine the effect of intermittent, nearly vertical, patient positioning in a specialized upright bed, on outcomes of mechanically ventilated patients with acute respiratory distress syndrome (ARDS) who are in the ICU.

Full description

The purpose of this study is to determine the effect of intermittent, nearly vertical, patient positioning in a specialized upright bed, on outcomes of mechanically ventilated patients with acute respiratory distress syndrome (ARDS) who are in the ICU. This study is a prospective, non-blinded, feasibility, randomized study of ARDS patients, who will be randomized into two treatment groups. One treatment arm will deliver scheduled sessions of upright bed positioning (study intervention), while the other treatment arm receives routine bed position care (care provided exclusively with the bed in the supine position). ICU Practitioners know that positional changes improve clinical outcomes when turning patients from supine to prone (back to belly); however, other positional changes including upright positioning are far less studied. It is well known that in ARDS patients who become proned, an improvement in aeration occurs in the dorsal lung regions (prone positioning has been shown to reduce ARDS mortality). Thus the investigators predict that in this study, the upright positioning holds the potential to further recruit collapsed lung areas. Augmentation of aerated lung while in the upright position is expected to increase the highest value measured per ventilator day of the respiratory system compliance in the upright bed position arm, in a greater fashion than the highest value measured per ventilator day of daily total respiratory system compliance for the usual care arm.

Enrollment: 5 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Berlin criteria ARDS

Exclusion criteria

• ARDS greater than 72 hours
• Neurologic disease known to prolong weaning
• Pregnancy
• Known diagnosis of pulmonary fibrosis
• Implanted cardiac pacer/defibrillator
• prisoner

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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5 participants in 2 patient groups

Control

No Intervention group

Description:

Usual Care

Intervention

Active Comparator group

Description:

Intervention arm

Treatment:

Procedure: upright bed