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CompletedNCT01102322Updated Feb 21, 2011

Factors Associated With the Use of Lung Protective Ventilation Strategy (LPV) in Acute Lung Injury/Acute Respiratory Distress Syndrome (ALI/ARDS) Patients in Intensive Care Unit (ICU)

An observational study in Acute Respiratory Distress Syndrome, sponsored by National Taiwan University Hospital. Completed at 1 site in Taiwan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-02-21.

Sponsored by National Taiwan University Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
111
Ages
18 Years and older
Sex
All
01

Study summary

In 1967, Ashbaugh et al first described 12 patients with a syndrome characterized by the acute onset dyspnea, severe hypoxemia, diffuse lung infiltrates on the chest radiography and decreased lung compliance. Moreover, in 1988, Murray et al proposed a lung injury scoring system based on the level of positive end-expiratory pressure (PEEP), PaO2-to-FiO2 ratio, static lung compliance, degree of infiltrates on the chest radiograph, and clinical cause. A score of 2.5 or greater was considered to be consistent with a diagnosis of ARDS. The current definition of ARDS was proposed by Bernard et al and the American-European Consensus Conference in 1994. The criteria of ARDS included: 1) acute onset; 2) a PaO2/FIO2 ratio, or hypoxia score, of \< 200, regardless of positive endexpiratory pressure; 3) bilateral infiltrates on chest radiograph; and 4) a pulmonary artery occlusion pressure of \<18 mm Hg or the absence of clinical evidence of left atrial hypertension.

However, despite advances in ventilator management, the mortality rate of acute lung injury and the acute respiratory distress syndrome remains very high (approximately 40 to 50 percent). In 2000, ARDS Network trial compared the effects of 6 versus 12 mL/kg of tidal volume per predicted body weight (PBW) among 861 patients and noted an overall 22% reduction in mortality rate, more ventilator-free days, and more organ-failure-free days in the low-tidal-volume group. Therefore, the current approach to mechanical ventilation of a patient with ARDS emphasizes the use of lower tidal volumes with lower pressures to avoid causing lung overdistension and ventilator associated lung injury.

Nevertheless, one year after publication of the ARDSnet trial, Rubenfeld et al noted that lung-protective ventilation strategies were applied in less than 5% of patients with ARDS or ALI at a single ARDSnet center. Rubenfeld et al found that common barriers to the initiation of low tidal volume ventilation include unwillingness to relinquish control of the ventilator, failure to recognize patients as having ALI/ARDS, and perceived contraindications to low tidal volume ventilation. Significant barriers to the continuation of low tidal volume ventilation include concerns regarding patient discomfort and tachypnea or hypercapnia and acidosis.

In addition, Kalhan et al also evaluated factors associated with the choice of tidal volume and he reported that underuse of LPV may be related to clinicians' under-recognition of less severe cases of ALI, and their reserving of low-tidal volume ventilation for more severe cases, or both. However, the factors such as comorbidity and pathophysiological change associated with underuse of lung protective ventilation strategy are not clear. The investigators perform a prospective single-center study to investigate the factors associated with the use of lung protective ventilation strategy (LPV) in ALI/ARDS patients in ICU.

Read the detailed description

In 1967, Ashbaugh et al first described 12 patients with a syndrome characterized by the acute onset dyspnea, severe hypoxemia, diffuse lung infiltrates on the chest radiography and decreased lung compliance. The syndrome, initially called acute respiratory distress in adult and is now named as the acute respiratory distress syndrome (ARDS). Moreover, in 1988, Murray et al proposed a lung injury scoring system based on the level of positive end-expiratory pressure (PEEP),PaO2-to-FiO2 ratio, static lung compliance, degree of infiltrates on the chest radiograph, and clinical cause. A score of 2.5 or greater was considered to be consistent with a diagnosis of ARDS. The current definition of ARDS was proposed by Bernard et al and the American-European Consensus Conference in 1994. The criteria of ARDS included: 1) acute onset; 2) a PaO2/FIO2 ratio, or hypoxia score, of \<200, regardless of positive endexpiratory pressure; 3) bilateral infiltrates on chest radiograph; and 4) a pulmonary artery occlusion pressure of \<18 mm Hg or the absence of clinical evidence of left atrial hypertension.

However, despite advances in ventilator management, the mortality rate of acute lung injury and the acute respiratory distress syndrome remains very high (approximately 40 to 50 percent). In 2000, ARDS Network trial compared the effects of 6 versus 12 mL/kg of tidal volume per predicted body weight(PBW) among 861 patients and noted an overall 22% reduction in mortality rate, more ventilator-free days, and more organ-failure-free days in the low-tidal-volume group. Therefore, the current approach to mechanical ventilation of a patient with ARDS emphasizes the use of lower tidal volumes with lower pressures to avoid causing lung overdistension and ventilator associated lung injury.

Nevertheless, one year after publication of the ARDSnet trial, Rubenfeld et al noted that lung-protective ventilation strategies were applied in less than 5% of patients with ARDS or ALI at a single ARDSnet center. Rubenfeld et al found that common barriers to the initiation of low tidal volume ventilation include unwillingness to relinquish control of the ventilator, failure to recognize patients as having ALI/ARDS, and perceived contraindications to low tidal volume ventilation. Significant barriers to the continuation of low tidal volume ventilation include concerns regarding patient discomfort and tachypnea or hypercapnia and acidosis.

In addition, Kalhan et al also evaluated factors associated with the choice of tidal volume and he reported that underuse of LPV may be related to clinicians' under-recognition of less severe cases of ALI, and their reserving of low-tidal volume ventilation for more severe cases, or both. However, the factors such as comorbidity and pathophysiological change associated with underuse of lung protective ventilation strategy are not clear. We perform a prospective single-center study to investigate the factors associated with the use of lung protective ventilation strategy (LPV) in ALI/ARDS patients in ICU

02

Conditions studied

  • Acute Respiratory Distress Syndrome

Keywords

  • Acute respiratory distress syndrome
03

In context

Respiratory Distress Syndrome

1,597 studies on the registry are indexed under Respiratory Distress Syndrome; 312 are open to participants now.

This study's enrollment of 111 is above the median of 100 across 540 observational studies indexed under Respiratory Distress Syndrome.

Browse Respiratory Distress Syndrome studies →

Lead sponsor

National Taiwan University Hospital is the lead sponsor of 2,563 studies on the registry; 569 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Acute respiratory distress syndrome patients

Inclusion criteria

  • All intubated and mechanically ventilated patients who meet the criteria of American-European Consensus Conference (AECC) criteria for ALI/ ARDS:
  • Acute onset of illness
  • Bilateral (patchy, diffuse, or homogeneous) infiltrates consistent with pulmonary edema
  • PaO2/FiO2 \<=300 (corrected for altitude): (P/F \<300 for ALI and P/F \<200 for ARDS)
  • No clinical evidence of left atrial hypertension

Exclusion criteria

Exclusion Criteria:

  • Age \<18 years
  • Enrolled in other clinical trials
  • Had confirmed alternative diagnoses that would have different clinical course than ARDS/ALI, e.g., diffuse alveolar hemorrhage, vasculitis, interstitial pneumonitis, etc.
  • Congestive heart failure related pulmonary edema
  • Acute myocardial infarction
  • Pregnancy
  • Patients with definite contraindication to the use of low-tidal volume ventilation, e.g., increased intracranial pressure, tricyclic antidepressant overdose, etc.
  • The patient who meets inclusion criteria initially but rapidly improved within 24 hours of diagnosis of ARDS/ALI
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
111 participants (actual)

Groups and cohorts

  • 1

    Behavioral: Quality

Interventions

  • BehavioralQuality

    Factors associated with the use of lung protective ventilation strategy (LPV) in ALI/ARDS patients in ICU

06

What researchers measure

Primary outcomes

  1. The rate of appropriately use of Lung Protective strategy in ALI/ARDS patients

    Time frame: 7 days

07

Study locations

1 site
  • Jih-Shuin Jerng
    Taipei, 100, Taiwan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 21, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01102322
Lead sponsor
National Taiwan University Hospital
First posted
Apr 13, 2010
Start date
Mar 2010
Primary completion
Jan 2011
Completion
Feb 2011
Last update
Feb 21, 2011

Study contacts

Jih-Shuin Jerng
principal investigator · National Taiwan University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2011. You cannot join it, but the record below documents what was studied.

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