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

May 5, 2009 updated by: Assistance Publique - Hôpitaux de Paris

A Cluster-Randomized Two-Period Cross-Over Study Comparing Routine and on-Demand Prescription of Chest Radiographs in Mechanically Ventilated Adults : the RARE Study

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

849

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75012
        • Hôpital Saint-Antoine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All newly admitted adult patients receiving mechanical ventilation at the time of the morning visit in ICU

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
1
Routine strategy of chest radiograph prescription
2
On-demand strategy of chest radiograph prescription

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Average number of chest radiographs per patient-day during mechanical ventilation
Time Frame: Every patient-day during mechanical ventilation.
Every patient-day during mechanical ventilation.

Secondary Outcome Measures

Outcome Measure
Time Frame
Mortality rate in ICU
Time Frame: During the inpatient stay in ICU
During the inpatient stay in ICU
Average length of stay
Time Frame: During the inpatient stay in ICU
During the inpatient stay in ICU
Average duration of mechanical ventilation
Time Frame: During the inpatient stay in ICU
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
During the inpatient stay in ICU

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Bertrand GUIDET, MD PhD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (Actual)

August 1, 2007

Study Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

May 5, 2009

First Submitted That Met QC Criteria

May 5, 2009

First Posted (Estimate)

May 6, 2009

Study Record Updates

Last Update Posted (Estimate)

May 6, 2009

Last Update Submitted That Met QC Criteria

May 5, 2009

Last Verified

May 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SCR06006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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