NCT01552070

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2010

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

March 8, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 13, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

September 17, 2013

Status Verified

September 1, 2013

Enrollment Period

2.7 years

First QC Date

March 8, 2012

Last Update Submit

September 13, 2013

Conditions

Acute Respiratory Distress SyndromeAcute Lung Injury

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • cytokines change with/without recruitment maneuver.

    28 days

  • ventilator use duration

    28days

  • weaning rate

    28days

  • ICU stay

    28days

  • ICU survival

    28days

Study Arms (2)

With recruitment maneuver group

EXPERIMENTAL

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

Without recuritment maneuver

ACTIVE COMPARATOR

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

Interventions

Recruitment maneuverBEHAVIORAL

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

With recruitment maneuver group
without recruit maneuverOTHER

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.

Without recuritment maneuver

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

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

Taipei, Taiwan

Location

Sant Paul Hospital

Taoyuan District, Taiwan

Location

MeSH Terms

Conditions

Respiratory Distress SyndromeAcute Lung Injury

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration DisordersLung Injury

Study Officials

  • Horng-Chyuan Lin, MD

    Change Gung Memorial Hospital

    PRINCIPAL INVESTIGATOR

  • Fu-Tsai Chung, MD

    Chang Gung Memorial Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of The Fifth Medical Intensive Care Unit , Assistant Professor

Study Record Dates

First Submitted

March 8, 2012

First Posted

March 13, 2012

Study Start

September 1, 2010

Primary Completion

May 1, 2013

Study Completion

July 1, 2013

Last Updated

September 17, 2013

Record last verified: 2013-09

Locations

TW(2)