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

Chang Gung Medical Foundation

Status and phase: Completed; Phase 2

Conditions: Acute Lung Injury; Acute Respiratory Distress Syndrome

Treatments: Other: without recruit maneuver; Behavioral: Recruitment maneuver

Study type: Interventional

Funder types: Other

Identifiers

NCT01552070

99-0362A3

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No 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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

With recruitment maneuver group

Experimental group

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.

Treatment:

Behavioral: Recruitment maneuver

Without recuritment maneuver

Active Comparator group

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.

Treatment:

Other: without recruit maneuver