NCT00893672

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
849

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2006

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 5, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 6, 2009

Completed
Last Updated

May 6, 2009

Status Verified

May 1, 2009

Enrollment Period

8 months

First QC Date

May 5, 2009

Last Update Submit

May 5, 2009

Conditions

Keywords

Radiography, ThoracicIntensive Care UnitsVentilation, mechanicalMatched-Pair Analysis

Outcome Measures

Primary Outcomes (1)

  • Average number of chest radiographs per patient-day during mechanical ventilation

    Every patient-day during mechanical ventilation.

Secondary Outcomes (4)

  • Mortality rate in ICU

    During the inpatient stay in ICU

  • Average length of stay

    During the inpatient stay in ICU

  • Average duration of mechanical ventilation

    During the inpatient stay in ICU

  • Number of radiographs with new findings leading to therapeutic or diagnostic interventions

    During the inpatient stay in ICU

Study Arms (2)

1

Routine strategy of chest radiograph prescription

2

On-demand strategy of chest radiograph prescription

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Patients with mechanical ventilation lasting less than 2 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Saint-Antoine

Paris, Paris, 75012, France

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Bertrand GUIDET, MD PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 5, 2009

First Posted

May 6, 2009

Study Start

December 1, 2006

Primary Completion

August 1, 2007

Study Completion

April 1, 2009

Last Updated

May 6, 2009

Record last verified: 2009-05

Locations