Recruitment on Extravascular Lung Water in Acute Respiratory Distress Syndrome (ARDS)

Acute Respiratory Distress Syndrome Clinical Trial

Official title:

Impact of Alveolar Recruitment Maneuver on Extravascular Lung Water of Patients With Acute Lung Injury/Acute Respiratory Distress Syndrome.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01552070
• Other study ID #: 99-0362A3
• Status: Completed
• Phase: Phase 2
• First received: March 8, 2012
• Last updated: September 13, 2013
• Start date: September 2010
• Est. completion date: July 2013

Study information

• Verified date: September 2013
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Lung Injury
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Syndrome

Intervention

Behavioral:
• Recruitment 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.

Other:
• without 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.

Locations

Country	Name	City	State
Taiwan	Department of Thoracic Medicine, Shuang Ho Hospital, Taipei Medical University	Taipei
Taiwan	Sant Paul Hospital	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Extravascular lung water change with/without recruitment maneuver.	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.	7 days	Yes
Secondary	cytokines change with/without recruitment maneuver.	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.	28 days	No
Secondary	ventilator use duration	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.	28days	No
Secondary	weaning rate	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.	28days	No
Secondary	ICU stay	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.	28days	Yes
Secondary	ICU survival	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.	28days	No