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

NCT ID: NCT01552070

Last Updated: 2013-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2013-07-31

Brief Summary

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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

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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.

Conditions

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Acute Respiratory Distress Syndrome Acute Lung Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Recruitment maneuver

Intervention Type BEHAVIORAL

Recruitment maneuver will be performed immediately (within 2 minutes) after intubation, consisting of a continuous positive airway pressure of 40 cmH2O over 30 seconds.

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.

Group Type ACTIVE_COMPARATOR

without recruit maneuver

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Chung Fu-Tsai

Chief of The Fifth Medical Intensive Care Unit , Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Horng-Chyuan Lin, MD

Role: PRINCIPAL_INVESTIGATOR

Change Gung Memorial Hospital

Fu-Tsai Chung, MD

Role: PRINCIPAL_INVESTIGATOR

Chang Gung Memorial Hospital

Locations

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Department of Thoracic Medicine, Shuang Ho Hospital, Taipei Medical University

Taipei, , Taiwan

Site Status

Sant Paul Hospital

Taoyuan District, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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99-0362A3

Identifier Type: -

Identifier Source: org_study_id