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

Primary Purpose

Acute Respiratory Distress Syndrome, Acute Lung Injury

Status
Completed
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
Recruitment maneuver
without recruit maneuver
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Acute Respiratory Distress Syndrome

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

With recruitment maneuver group

Without recuritment maneuver

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.

Full Information

First Posted
March 8, 2012
Last Updated
September 13, 2013
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01552070
Brief Title
Recruitment on Extravascular Lung Water in Acute Respiratory Distress Syndrome (ARDS)
Official Title
Impact of Alveolar Recruitment Maneuver on Extravascular Lung Water of Patients With Acute Lung Injury/Acute Respiratory Distress Syndrome.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Distress Syndrome, Acute Lung Injury

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
With recruitment maneuver group
Arm Type
Experimental
Arm Description
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.
Arm Title
Without recuritment maneuver
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Recruitment maneuver
Intervention Description
Recruitment maneuver will be performed immediately (within 2 minutes) after intubation, consisting of a continuous positive airway pressure of 40 cmH2O over 30 seconds.
Intervention Type
Other
Intervention Name(s)
without recruit maneuver
Intervention Description
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.
Primary Outcome Measure Information:
Title
Extravascular lung water change with/without recruitment maneuver.
Description
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.
Time Frame
7 days
Secondary Outcome Measure Information:
Title
cytokines change with/without recruitment maneuver.
Description
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.
Time Frame
28 days
Title
ventilator use duration
Description
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.
Time Frame
28days
Title
weaning rate
Description
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.
Time Frame
28days
Title
ICU stay
Description
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.
Time Frame
28days
Title
ICU survival
Description
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.
Time Frame
28days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Horng-Chyuan Lin, MD
Organizational Affiliation
Change Gung Memorial Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fu-Tsai Chung, MD
Organizational Affiliation
Chang Gung Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Thoracic Medicine, Shuang Ho Hospital, Taipei Medical University
City
Taipei
Country
Taiwan
Facility Name
Sant Paul Hospital
City
Taoyuan
Country
Taiwan

12. IPD Sharing Statement

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

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