Clinical Impact of Different Duration Prone Postition Treatment for Patients With ARDS.
Keywords
Abstract
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.
Dates
| Last Verified: | 04/30/2020 |
| First Submitted: | 04/09/2020 |
| Estimated Enrollment Submitted: | 05/11/2020 |
| First Posted: | 05/17/2020 |
| Last Update Submitted: | 05/11/2020 |
| Last Update Posted: | 05/17/2020 |
| Actual Study Start Date: | 05/31/2020 |
| Estimated Primary Completion Date: | 12/30/2022 |
| Estimated Study Completion Date: | 12/30/2022 |
Condition or disease
Intervention/treatment
Procedure: prone position
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Active Comparator: 16-hour prone position measure vital signs, PaO2/FiO2, driving pressure one hour before prone position and 1-hour, 8-hour, 16-hour after prone position | |
| Experimental: 24-hour prone position measure vital signs, PaO2/FiO2, driving pressure one hour before prone position and 1-hour, 8-hour, 16-hour, 24- hour after prone position |
Eligibility Criteria
| Ages Eligible for Study | 20 Years To 20 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| 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). |
Outcome
Primary Outcome Measures
1. oxygenation [Change from baseline PaO2/FiO2 at 24-hour after prone position]
Secondary Outcome Measures
1. respiratory parameters [Change from baseline driving pressure at 24-hour after prone position]
2. vital sign [Change from baseline driving pressure at 24-hour after prone position]
3. duration of stay [up to 3 months]
4. complication [up to 3 months]
5. survival [one year]
