Clinical trial NCT04612608: Assessing the Role of Inclined Positioning in Acute Respiratory Distress Syndrome Patients Recovery
Official title: Assessing the Role of Inclined Positioning in Acute Respiratory Distress Syndrome Patients Recovery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ARDS, Human
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2020-11-03
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The intervention arm will undergo a protocol of 4x per day bed elevation to 60 degrees for 30 minutes.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: highest value per day of mechanical ventilation of total respiratory system compliance
timeFrame: from the day of randomization, every day of mechanical ventilation until death or liberation from mechanical ventilation up to day 28
Secondary outcomes:
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
References: