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

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Respiratory Distress Syndrome; Acute Lung Injury
• Intervention / Treatment: Behavioral: Recruitment maneuver; Other: without recruit 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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Department of Thoracic Medicine, Shuang Ho Hospital, Taipei Medical University
  • Taoyuan, Taiwan
    • Sant Paul Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: March 8, 2012
• First Submitted That Met QC Criteria: March 9, 2012
• First Posted (Estimate): March 13, 2012

Study Record Updates

• Last Update Posted (Estimate): September 17, 2013
• Last Update Submitted That Met QC Criteria: September 13, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Wounds and Injuries; Disease; Infant, Newborn, Diseases; Infant, Premature, Diseases; Thoracic Injuries; Syndrome; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Lung Injury
• Other Study ID Numbers: 99-0362A3