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The study was designed to comparison the effectiveness of recruitment maneuvers(RM) and lung protective ventilation strategy(LPVS) for patients with moderate to severe ARDS.
ARDS patients were randomly divided into two groups, the experimental group (LPVS+RM group) and the control group (LPVS group). The method of RM refers to that under FiO2=100% oxygen concentration and fixed inspiratory pressure (15cmH2O), the PEEP starts from 10 cmH2O and increases at a pressure of 5 cmH2O every minute until the Peak inspiratory Pressure(PIP) reaches 55cmH2O, and the arterial blood oxygen is monitored at the same time. The pressure point when the partial pressure of arterial oxygen PaO2+PaCO2≧400mmHg is the best PEEP. The primary endpoint indicators were oxygenation index(OI) and lung ultrasound score(LUS) from day 1 to day 7. The secondary outcome indicators were the ventilator days, length of stay in the ICU (days), and ICU mortality.
ARDS patients were randomly divided into two groups, the experimental group (LPVS+RM group) and the control group (LPVS group). The method of RM refers to that under FiO2=100% oxygen concentration and fixed inspiratory pressure (15cmH2O), the PEEP starts from 10 cmH2O and increases at a pressure of 5 cmH2O every minute until the Peak inspiratory Pressure(PIP) reaches 55cmH2O, and the arterial blood oxygen is monitored at the same time. The pressure point when the partial pressure of arterial oxygen PaO2+PaCO2≧400mmHg is the best PEEP. The primary endpoint indicators were oxygenation index(OI) and lung ultrasound score(LUS) from day 1 to day 7. The secondary outcome indicators were the ventilator days, length of stay in the ICU (days), and ICU mortality.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LPVS group | Placebo Comparator | The general ventilator setting. |
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| LPVS + RM group | Experimental | Recruitment maneuver. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RM | Procedure | RM refers to that under FiO2=100% oxygen concentration and fixed inspiratory pressure (15cmH2O), the PEEP starts from 10 cmH2O and increases at a pressure of 5 cmH2O every minute until the Peak inspiratory Pressure(PIP) reaches 55cmH2O, and the level was fixed to 40 seconds in each increment. Then, the ventilator was transferred to PEEP-titration phase, the PEEP was adjusted to 25 cm H2O, and it was reduced by increments of 5 cm H2O each time. The each increment was fixed to 5 minutes till the end-maneuver PEEP. |
| Measure | Description | Time Frame |
|---|---|---|
| Oxygenation index(OI) | Difference in OI between baseline and 72 hrs after enrollment 【The oxygenation index assesses the intensity of ventilatory support that is needed to maintain adequate oxygenation. The formula is: Oxygenation index = (FiO2 x PAW) / PaO2. The lower the OI(<25) the better the outcome】 | Baseline - 72 hrs after enrollment |
| Lung ultrasound score(LUS) | Difference in LUS between baseline and 72 hrs after enrollment 【LUS is a score that measures lung aeration, score ranging from 0 to 36 points, the higher the score is mean the worse the ventilation of the lungs】 | Baseline - 72 hrs after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Ventilator days | Removal of endotracheal tube without ventilator support days | Removal of endotracheal tube day - Insertion endotracheal tube day + 1 day |
| Length of stay in the ICU (days) | Total days of admission ICU |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zi-Tin Kuan, RN | Contact | 886-966083885 | kuan.zitin@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Zi-Tin Kuan, RN | Asia University Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asia University | Recruiting | Taichung | Wufeng | 41354 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28746224 | Result | Chung FT, Lee CS, Lin SM, Kuo CH, Wang TY, Fang YF, Hsieh MH, Chen HC, Lin HC. Alveolar recruitment maneuver attenuates extravascular lung water in acute respiratory distress syndrome. Medicine (Baltimore). 2017 Jul;96(30):e7627. doi: 10.1097/MD.0000000000007627. |
| Label | URL |
|---|---|
| doi: 10.1097/MD.0000000000007627 | View source |
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| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
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| LPVS | Procedure | LPVS was used by the pressure-controlled mode and the PEEP was titrated by the level of FiO2 to keep the saturation of oxygen (SaO2) more than 90%. The level of pressure control was adjusted to maintain low tidal volume (6-8 mL/kg predicted body weight [PBW]) strategy. The respiratory rate and tidal volume were setting to avoid unstable hemodynamic data and adjusted by blood gas data and lung mechanics. |
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| Transfer out of ICU day - Admission to ICU day + 1 day |
| ICU mortality | In ICU death after admission to the ICU | During ICU course |