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Comparison of Two Chest Radiograph Prescription Strategies in Intensive Care Unit (RARE)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00893672
First Posted: May 6, 2009
Last Update Posted: May 6, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Assistance Publique - Hôpitaux de Paris
  Purpose
Current guidelines recommend Routine daily chest radiographs (CXRs) for mechanically ventilated patients in intensive care units (ICUs). However, some ICUs have shifted to an On-demand strategy, in which this CXR is only prescribed if warranted by the patient's status at the morning physical examination. Here the investigators compared Routine and On-demand strategies in 21 French ICUs. The working hypothesis was that CXR prescriptions would fall by at least 20% with the On-demand strategy, with no reduction in quality of care.

Condition
Patient Care Quality of Health Care Intensive Care Units Ventilation, Mechanical

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: A Cluster-Randomized Two-Period Cross-Over Study Comparing Routine and on-Demand Prescription of Chest Radiographs in Mechanically Ventilated Adults : the RARE Study

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Average number of chest radiographs per patient-day during mechanical ventilation [ Time Frame: Every patient-day during mechanical ventilation. ]

Secondary Outcome Measures:
  • Mortality rate in ICU [ Time Frame: During the inpatient stay in ICU ]
  • Average length of stay [ Time Frame: During the inpatient stay in ICU ]
  • Average duration of mechanical ventilation [ Time Frame: During the inpatient stay in ICU ]
  • Number of radiographs with new findings leading to therapeutic or diagnostic interventions [ Time Frame: During the inpatient stay in ICU ]

Enrollment: 849
Study Start Date: December 2006
Study Completion Date: April 2009
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Routine strategy of chest radiograph prescription
2
On-demand strategy of chest radiograph prescription

Detailed Description:
Based on a cluster-randomized two-period two-strategies cross-over design, respectively 11 and 10 participating ICUs applied the Routine and On-demand strategies during the first period, each enrolling 20 consecutive patients requiring mechanical ventilation for at least two days. Each ICUs applied then applied the alternative strategy during the second period, again enrolling 20 consecutive patients.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All newly admitted adult patients receiving mechanical ventilation at the time of the morning visit in ICU
Criteria

Inclusion Criteria:

  • All newly admitted adult patients receiving mechanical ventilation at the time of the morning visit-any day during their ICU stay

Exclusion Criteria:

  • Patients with mechanical ventilation lasting less than 2 days
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00893672


Locations
France
Hopital Saint-Antoine
Paris, France, 75012
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Bertrand GUIDET, MD PhD Assistance Publique - Hôpitaux de Paris
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Zakia IDIR, Department Clinical Research of Developpement
ClinicalTrials.gov Identifier: NCT00893672     History of Changes
Other Study ID Numbers: SCR06006
First Submitted: May 5, 2009
First Posted: May 6, 2009
Last Update Posted: May 6, 2009
Last Verified: May 2009

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Radiography, Thoracic
Intensive Care Units
Ventilation, mechanical
Matched-Pair Analysis