Comparison of Two Chest Radiograph Prescription Strategies in Intensive Care Unit

Intensive Care Units Clinical Trial

— RARE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00893672
• Other study ID #: SCR06006
• Status: Completed
• Phase: N/A
• First received: May 5, 2009
• Last updated: May 5, 2009
• Start date: December 2006
• Est. completion date: April 2009

Study information

• Verified date: May 2009
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: French Data Protection Authority
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 849
• Est. completion date: April 2009
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Crossover, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
France	Hopital Saint-Antoine	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average number of chest radiographs per patient-day during mechanical ventilation		Every patient-day during mechanical ventilation.	No
Secondary	Mortality rate in ICU		During the inpatient stay in ICU	Yes
Secondary	Average length of stay		During the inpatient stay in ICU	No
Secondary	Average duration of mechanical ventilation		During the inpatient stay in ICU	No
Secondary	Number of radiographs with new findings leading to therapeutic or diagnostic interventions		During the inpatient stay in ICU	No