Acute Lung Injury, Acute Respiratory Distress Syndrome
Conditions
Brief summary
The purpose of this study is to investigate the change of extravascular lung water (EVLW), cytokine and oxygenation parameters in patients with acute lung injury (ALI) or acute respiratory distress syndrome (ARDS) after alveolar recruitment maneuver.
Detailed description
This investigation is a prospective randomized control study. Informed consents will be obtained from all patients or their surrogates prior to the procedure of alveolar recruitment maneuver and PiCCO monitoring system. Patients and methods: From September 2010 to September 2012, consecutive patients with ALI/ARDS undergo alveolar recruitment maneuver will be enrolled at Chang Gung Memorial Hospital, a university-affiliated hospital in Taiwan. EVLW will be measured by PiCCO monitoring system, alveolar recruitment maneuver will be setting by protocol under supervision of chest physicians and respiratory therapists. Serum cytokine such as endothelin-1, TNF-, IL-6, Tie-1, Tie-2, angiopoietin-1, angiopoietin-2,VEGF and thrombomodulin will be measured.
Interventions
BEHAVIORALRecruitment maneuver
Recruitment maneuver will be performed immediately (within 2 minutes) after intubation, consisting of a continuous positive airway pressure of 40 cmH2O over 30 seconds.
OTHERwithout recruit maneuver
After oral intubation, each patient will be mechanically ventilated, with a tidal volume of 6mL/kg, a respiratory rate of 20 to 25 breaths/minute, a positive end-expiratory pressure (PEEP) of 5 cmH2O, and an FiO2 of 100%. PEEP titration according to FiO2 and ARDSnet.
Sponsors
Chang Gung Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* acute hypoxemic respiratory failure requiring intubation; and hypoxemia, defined as a partial pressure of arterial oxygen (PaO2) less than 100 mmHg under a high fraction of inspired oxygen (FiO2) * PaO2/FiO2 ratio \< 200.
Exclusion criteria
* encephalopathy or coma, * a need for cardiac resuscitation, * hyperkalemia of more than 5.5 mEq/L (contraindication to the succinylcholine use), * acute brain injury, * pregnancy, * age less 20 years old or recent thoracic surgery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Extravascular lung water change with/without recruitment maneuver. | 7 days | The Extrvascular lung water (EVLW) measurement will be based on transpulmonary thermodilution method. This method was recently introduced as part of the PiCCO plus system (Pulsion Medical System, Munich, Germany). EVLW were recorded and compared between patients with and without recruitment manevuer. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| cytokines change with/without recruitment maneuver. | 28 days | From September 2010 to September 2012, consecutive patients with ALI/ARDS undergo recruitment maneuver or not randomly will be enrolled. Serum cytokine such as endothelin-1, TNF-, IL-6, Tie-1, Tie-2, angiopoietin-1, angiopoietin-2,VEGF and thrombomodulin will be measured. Further ventilator use duration, weaning rate, ICU stay, safety and ICU survival were recorded and compared between patients with and without recruitment manevuer. |
| ventilator use duration | 28days | From September 2010 to September 2012, consecutive patients with ALI/ARDS undergo recruitment maneuver or not randomly will be enrolled. Serum cytokine such as endothelin-1, TNF-, IL-6, Tie-1, Tie-2, angiopoietin-1, angiopoietin-2,VEGF and thrombomodulin will be measured. Further ventilator use duration, weaning rate, ICU stay, safety and ICU survival were recorded and compared between patients with and without recruitment manevuer. |
| weaning rate | 28days | From September 2010 to September 2012, consecutive patients with ALI/ARDS undergo recruitment maneuver or not randomly will be enrolled. Serum cytokine such as endothelin-1, TNF-, IL-6, Tie-1, Tie-2, angiopoietin-1, angiopoietin-2,VEGF and thrombomodulin will be measured. Further ventilator use duration, weaning rate, ICU stay, safety and ICU survival were recorded and compared between patients with and without recruitment manevuer. |
| ICU stay | 28days | From September 2010 to September 2012, consecutive patients with ALI/ARDS undergo recruitment maneuver or not randomly will be enrolled. Serum cytokine such as endothelin-1, TNF-, IL-6, Tie-1, Tie-2, angiopoietin-1, angiopoietin-2,VEGF and thrombomodulin will be measured. Further ventilator use duration, weaning rate, ICU stay, safety and ICU survival were recorded and compared between patients with and without recruitment manevuer. |
| ICU survival | 28days | From September 2010 to September 2012, consecutive patients with ALI/ARDS undergo recruitment maneuver or not randomly will be enrolled. Serum cytokine such as endothelin-1, TNF-, IL-6, Tie-1, Tie-2, angiopoietin-1, angiopoietin-2,VEGF and thrombomodulin will be measured. Further ventilator use duration, weaning rate, ICU stay, safety and ICU survival were recorded and compared between patients with and without recruitment manevuer. |
Countries
Taiwan
Outcome results
None listed