Aspirated Foreign Body of Lower Respiratory TractSICENCT00747981
Thoracic Computed Tomography Scan for Diagnosis of Aspirated Foreign Bodies.
A study testing Thoracic CT Scan in people with Aspirated Foreign Body of Lower Respiratory Tract, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
To access CT Scan as a diagnostic tool for foreign bodies aspiration. Read more about this study
- Who is it for?
- Ages 6 months to 16 years
- Conditions the study is for
- Aspirated Foreign Body of Lower Respiratory Tract
- What is being tested?
- Thoracic CT Scan
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 311 participants
- Where
- 1 siteFrance
- Study dates
- May 2008to Oct 2011
- Phase
- Interventional
- 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 6 months to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- age between 6 months and 16 years
- suspicion of a foreign body aspiration
- health care assurance
- information of parents
Who cannot join
- emergency situation
- certainly of foreign body presence
- delay for CT Scan realization longer than 24 hours
- no speaking French parents
- parents refusal.
Trial locations and contacts
1 site in 1 country.
France1 site
Paris V University & Assistance Publique Hôpitaux de Paris
Paris, 75015
About this study
Official title: Management and Assessment of Thoracic CT Scan for Diagnosis of Aspirated Foreign Bodies in Children
To access CT Scan as a diagnostic tool for foreign bodies aspiration.
Read the detailed description
Comparison with gold standard diagnostic tool, the endoscopy
- Being tested
- Thoracic CT Scan
- Keywords
- CT Scan, Endoscopy, Aspiration, Foreign Bodies
- Medical subject headings
- Foreign Bodies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracic CT ScanProcedure or surgery
Perform a CT Scan and an endoscopy
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Thoracic CT Scan Receives: Procedure: Thoracic CT Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison between CT Scan and endoscopy results
Measured: 12 HOURS
Secondary outcomes (1)
X Ray radiation induced by CT Scan
Measured: TWO YEARS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2008 (estimated)
- Study startMay 2008
- Primary completionApr 2010
- Study completionOct 2011
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 Aspirated Foreign Body of Lower Respiratory TractStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 311 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Yves MANACH, MD, HDR, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00747981
- Sponsor's protocol ID
- K 070601
- Acronym
- SICE
- Status last verified
- Jan 2026
- First submitted
- 5 Sep 2008
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Manach Y, Pierrot S, Couloigner V, Ayari-Khalfallah S, Nicollas R, Venail F, Pondaven S, Baculard F, Tantcheu V. Diagnostic performance of multidetector computed tomography for foreign body aspiration in children. Int J Pediatr Otorhinolaryngol. 2013 May;77(5):808-12. doi: 10.1016/j.ijporl.2013.02.016. Epub 2013 Mar 13.
PubMed 23489882
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management and Assessment of Thoracic CT Scan for Diagnosis of Aspirated Foreign Bodies in Children
- ClinicalTrials.gov ID
- NCT00747981
- Acronym / sponsor ID
- SICE / K 070601
- Keywords
- CT Scan, Endoscopy, Aspiration, Foreign Bodies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 311 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- May 2008
- Primary completion
- Apr 2010 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 8 Sep 2008 (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.
To access CT Scan as a diagnostic tool for foreign bodies aspiration.
Detailed description
Comparison with gold standard diagnostic tool, the endoscopy
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Procedure: Thoracic CT ScanThoracic CT Scan |
Who may qualify
- Ages
- 6 months to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- age between 6 months and 16 years
- suspicion of a foreign body aspiration
- health care assurance
- information of parents
Key exclusion criteria (5 listed)
- emergency situation
- certainly of foreign body presence
- delay for CT Scan realization longer than 24 hours
- no speaking French parents
- parents refusal.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thoracic CT ScanPerform a CT Scan and an endoscopy | Procedure or surgery | A |
Primary outcome
Comparison between CT Scan and endoscopy results
Time frame: 12 HOURS
1 secondary outcome
X Ray radiation induced by CT Scan
Time frame: TWO YEARS
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 15 Jan 2026.
- Results publication: PubMed 23489882Manach Y, Pierrot S, Couloigner V, Ayari-Khalfallah S, Nicollas R, Venail F, Pondaven S, Baculard F, Tantcheu V. Diagnostic performance of multidetector computed tomography for foreign body aspiration in children. Int J Pediatr Otorhinolaryngol. 2013 May;77(5):808-12. doi: 10.1016/j.ijporl.2013.02.016. Epub 2013 Mar 13.
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.
Yves MANACH, MD, HDR 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?
A study testing Thoracic CT Scan in people with Aspirated Foreign Body of Lower Respiratory Tract, 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 4 inclusion and 5 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 15 Jan 2026. 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?
Comparison between CT Scan and endoscopy results (time frame: 12 HOURS). 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 NCT00747981, 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 15 Jan 2026.