Patient CareRARENCT00893672
Comparison of Two Chest Radiograph Prescription Strategies in Intensive Care Unit
An observational study of Patient Care and Quality of Health Care, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patient Care, Quality of Health Care, Intensive Care Units
- How many people
- 849 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2006to Apr 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All newly admitted adult patients receiving mechanical ventilation at the time of the morning visit in ICU
Who may be able to join
- All newly admitted adult patients receiving mechanical ventilation at the time of the morning visit-any day during their ICU stay
Who cannot join
- Patients with mechanical ventilation lasting less than 2 days
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Keywords
- Radiography, Thoracic, Intensive Care Units, Ventilation, mechanical, Matched-Pair Analysis
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Routine strategy of chest radiograph prescription | |
| 2 | On-demand strategy of chest radiograph prescription |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average number of chest radiographs per patient-day during mechanical ventilation
Measured: Every patient-day during mechanical ventilation.
Secondary outcomes (4)
Mortality rate in ICU
Measured: During the inpatient stay in ICU
Average length of stay
Measured: During the inpatient stay in ICU
Average duration of mechanical ventilation
Measured: During the inpatient stay in ICU
Number of radiographs with new findings leading to therapeutic or diagnostic interventions
Measured: During the inpatient stay in ICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2009 (estimated)
- Study startDec 2006
- Primary completionAug 2007
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patient CareStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 849 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Investigators
- Bertrand GUIDET, MD PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00893672
- Sponsor's protocol ID
- SCR06006
- Acronym
- RARE
- Status last verified
- May 2009
- First submitted
- 5 May 2009
- Last updated
- 6 May 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 19896184
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00893672
- Acronym / sponsor ID
- RARE / SCR06006
- Keywords
- Radiography, Thoracic, Intensive Care Units, Ventilation, mechanical, Matched-Pair Analysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 849 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Dec 2006
- Primary completion
- Aug 2007 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 6 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Routine strategy of chest radiograph prescription |
| 2 | – | –On-demand strategy of chest radiograph prescription |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All newly admitted adult patients receiving mechanical ventilation at the time of the morning visit in ICU
Key inclusion criteria (1 listed)
- All newly admitted adult patients receiving mechanical ventilation at the time of the morning visit-any day during their ICU stay
Key exclusion criteria (1 listed)
- Patients with mechanical ventilation lasting less than 2 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Average number of chest radiographs per patient-day during mechanical ventilation
Time frame: Every patient-day during mechanical ventilation.
4 secondary outcomes
Mortality rate in ICU
Time frame: During the inpatient stay in ICU
Average length of stay
Time frame: During the inpatient stay in ICU
Average duration of mechanical ventilation
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2009.
- Derived from this study: PubMed 19896184Hejblum 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bertrand GUIDET, MD PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patient Care and Quality of Health Care, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average number of chest radiographs per patient-day during mechanical ventilation (time frame: Every patient-day during mechanical ventilation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00893672, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2009.