Clinical trial NCT04391387: Clinical Impact of Different Duration Prone Postition Treatment for Patients With ARDS.
Official title: Clinical Impact of Different Duration Prone Postition Treatment for Patients With ARDS.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oxygenation
Driving Pressure
Keywords: acute respiratory distress syndrome
mechanical ventilation
oxygenation
prone position
protective lung ventilation
Lead sponsor: Kaohsiung Veterans General Hospital.
Sponsor class: OTHER
First posted: 2020-05-18
Enrollment: 45
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Acute respiratory distress syndrome (ARDS) is a life-threatening disease, patients with ARDS usually need mechanical ventilation. The treatment of ARDS include low tidal volume ventilation, steroid, extracorporeal membraneous oxygenator, inhaled nitric oxide or prone position . Some studies showed prone position had beneficial effect of oxygenation and mortality for severe ARDS patients, the duration of prone position should be at least 10 hours. It is unknown the optimal duration of prone position which is better for severe ARDS patients. This study will compare the clinical differences of 16-hour and 24-hour prone position for severe ARDS patients.

Detailed description: This is a prospective randomized controlled study. All severe ARDS patients were eligible for screening from January 2020 to December 2022. Inclusion criteria include: Patient above 20 year-old with diagnosis of severe ARDS under protective lung ventilation( tidal volume 4-8 ml/kg, plateau pressure \< 30cm H2O、PaO2/FiO2 \< 150 mmHg、PEEP ≥ 5 cmH2O、FiO2 \> 60%）. Patients were excluded if patients were not intubated and mechanically ventilated or contraindication for prone position ventilation (intracranial hemorrhage, massive hemoptysis, unstable hemodynamic status, recent pacemaker implantation, severe facial laceration, open abdominal wound, spine, femur or pelvis fracture or pregnancy). Patients will divide into 2 groups, one is patients supported by 16-hour prone position; another group is patients with 24-hour prone position, each group enrolled 30 patients. The medical records of these patients were analyzed for age, gender, body weight, diagnosis, pulmonary or extrapulmonary ARDS, acute physiology and chronic health evaluation (APACHE) Ⅱscore, days between ARDS to prone position, ICU day, hospital day, ventilator day, pre and post prone position vital signs, laboratory data including arterial blood gas, lactate, respiratory parameters included PaO2/FiO2, peak inspiratory pressure, positive end-expiratory pressure, ventilator mode, steroid treatment, complications (tube dislodge, pressure sore, infection), and mortality outcomes.

The primary endpoint is the difference of oxygenation (PaO2/FiO2), the secondary endpoint are other respiratory parameters, vital signs, ICU day, hospital day, ventilator day, complications and survival.

Eligibility criteria: Inclusion Criteria:

* Patient above 20 year-old with diagnosis of severe ARDS under protective lung ventilation (tidal volume 4-8 ml/kg, plateau pressure \< 30cm H2O、PaO2/FiO2 \< 150 mmHg、PEEP ≥ 5 cmH2O、FiO2 \> 60%).

Exclusion Criteria:

* Patients were not intubated and mechanically ventilated or contraindication for prone position ventilation (intracranial hemorrhage, massive hemoptysis, unstable hemodynamic status, recent pacemaker implantation, severe facial laceration, open abdominal wound, spine, femur or pelvis fracture or pregnancy).

Primary outcomes:
measure: oxygenation
timeFrame: Change from baseline PaO2/FiO2 at 24-hour after prone position
Secondary outcomes:
measure: respiratory parameters
timeFrame: Change from baseline driving pressure at 24-hour after prone position
measure: vital sign
timeFrame: Change from baseline driving pressure at 24-hour after prone position
measure: duration of stay
timeFrame: up to 3 months
measure: complication
timeFrame: up to 3 months
measure: survival
timeFrame: one year
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Veterans General Hospital
Study officials:
affiliation: Kaohsiung VGH
name: Chien Wei Hsu, MD
role: PRINCIPAL_INVESTIGATOR
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