Clinical trial NCT00893672: Comparison of Two Chest Radiograph Prescription Strategies in Intensive Care Unit
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patient Care
Quality of Health Care
Intensive Care Units
Ventilation, Mechanical
Keywords: Radiography, Thoracic
Intensive Care Units
Ventilation, mechanical
Matched-Pair Analysis
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2009-05-06
Enrollment: 849
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All newly admitted adult patients receiving mechanical ventilation at the time of the morning visit in ICU

Brief 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.

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 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

Primary outcomes:
measure: Average number of chest radiographs per patient-day during mechanical ventilation
timeFrame: Every patient-day during mechanical ventilation.
Secondary outcomes:
measure: Mortality rate in ICU
timeFrame: During the inpatient stay in ICU
measure: Average length of stay
timeFrame: During the inpatient stay in ICU
measure: Average duration of mechanical ventilation
timeFrame: During the inpatient stay in ICU
measure: Number of radiographs with new findings leading to therapeutic or diagnostic interventions
timeFrame: During the inpatient stay in ICU
Other outcomes:
Locations:
city: Paris
country: France
facility: Hopital Saint-Antoine
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Bertrand GUIDET, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hejblum G, Chalumeau-Lemoine L, Ioos V, Boelle PY, Salomon L, Simon T, Vibert JF, Guidet B. Comparison of routine and on-demand prescription of chest radiographs in mechanically ventilated adults: a multicentre, cluster-randomised, two-period crossover study. Lancet. 2009 Nov 14;374(9702):1687-93. doi: 10.1016/S0140-6736(09)61459-8. Epub 2009 Nov 4.