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

This study has been completed.
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00893672
First received: May 5, 2009
Last updated: NA
Last verified: May 2009
History: No changes posted
  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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mortality rate in ICU [ Time Frame: During the inpatient stay in ICU ] [ Designated as safety issue: Yes ]
  • Average length of stay [ Time Frame: During the inpatient stay in ICU ] [ Designated as safety issue: No ]
  • Average duration of mechanical ventilation [ Time Frame: During the inpatient stay in ICU ] [ Designated as safety issue: No ]
  • Number of radiographs with new findings leading to therapeutic or diagnostic interventions [ Time Frame: During the inpatient stay in ICU ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Assistance Publique - Hôpitaux de Paris

Additional 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
Study First Received: May 5, 2009
Last Updated: May 5, 2009
Health Authority: France: French Data Protection Authority

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

ClinicalTrials.gov processed this record on September 18, 2014