Recruitment on Extravascular Lung Water in Acute Respiratory Distress Syndrome (ARDS) - Full Text View

Purpose

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.

Condition	Intervention	Phase
Acute Respiratory Distress Syndrome Acute Lung Injury	Behavioral: Recruitment maneuver Other: without recruit maneuver	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic
Official Title:	Impact of Alveolar Recruitment Maneuver on Extravascular Lung Water of Patients With Acute Lung Injury/Acute Respiratory Distress Syndrome.

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Further study details as provided by Chang Gung Memorial Hospital:

Primary Outcome Measures:

Extravascular lung water change with/without recruitment maneuver. [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
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 Outcome Measures:

cytokines change with/without recruitment maneuver. [ Time Frame: 28 days ] [ Designated as safety issue: No ]
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 [ Time Frame: 28days ] [ Designated as safety issue: No ]
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 [ Time Frame: 28days ] [ Designated as safety issue: No ]
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 [ Time Frame: 28days ] [ Designated as safety issue: Yes ]
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 [ Time Frame: 28days ] [ Designated as safety issue: No ]
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.

Estimated Enrollment:	30
Study Start Date:	September 2010
Estimated Study Completion Date:	March 2013
Estimated Primary Completion Date:	January 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: With recruitment maneuver group Recruitment maneuver will be performed immediately (within 2 minutes) after intubation, consisting of a continuous positive airway pressure of 40 cmH2O over 30 seconds. Blood gases were sampled and blood samples taken for culture before, within 2 minutes, 5 minutes, and 30 minutes after intubation. Haemodynamic and respiratory parameters were continuously recorded throughout the study.	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.
Active Comparator: Without recuritment 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.	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.

Arms

Assigned Interventions

Experimental: With recruitment maneuver group

Recruitment maneuver will be performed immediately (within 2 minutes) after intubation, consisting of a continuous positive airway pressure of 40 cmH2O over 30 seconds. Blood gases were sampled and blood samples taken for culture before, within 2 minutes, 5 minutes, and 30 minutes after intubation. Haemodynamic and respiratory parameters were continuously recorded throughout the study.

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.

Active Comparator: Without recuritment 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.

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.

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.

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01552070

Contacts

Contact: Horng-Chyuan Lin, MD

+886-3+3281200 ext 8467

lin53424@ms13.hinet.net

Locations

Taiwan
Department of Thoracic Medicine, Shuang Ho Hospital, Taipei Medical University	Recruiting
Taipei, Taiwan
Contact: Hao-Cheng Chen, MD
Sant Paul Hospital	Recruiting
Taoyuan, Taiwan
Contact: Chih-Hsi Kuo, MD
Contact: Chun-Liang Chou, MD
Sub-Investigator: Fu-Tsai Chung, MD

Sponsors and Collaborators

Chang Gung Memorial Hospital

Investigators

Principal Investigator:	Horng-Chyuan Lin, MD	Change Gung Memorial Hospital
Principal Investigator:	Fu-Tsai Chung, MD	Chang Gung Memorial Hospital

More Information

No publications provided

Responsible Party:	Chung Fu-Tsai, Chief of The Fifth Medical Intensive Care Unit , Assistant Professor, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:	NCT01552070 History of Changes
Other Study ID Numbers:	99-0362A3
Study First Received:	March 8, 2012
Last Updated:	March 9, 2012
Health Authority:	Taiwan: Institutional Review Board

Additional relevant MeSH terms:

Respiratory Distress Syndrome, Adult
Acute Lung Injury
Respiratory Distress Syndrome, Newborn
Lung Injury
Lung Diseases
Respiratory Tract Diseases

Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Thoracic Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on June 17, 2013