Intubation, IntratrachealECOVERANCT02822846
Evaluation of the Ability to Diagnose the Position of the Intubation Probe Thanks to Lung Ultrasonography
An observational study of Intubation, Intratracheal, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The purpose of this study is to evaluate the diagnostic qualities of lung ultrasonography to monitor the position of the intubation probe. The primary assessment criterion is of study the position of the intubation probe with two examinations carried out independently : sonography chest radiography A correct position… Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Intubation, Intratracheal
- What is being tested?
- lung ultrasound
- How many people
- 79 participants
- Where
- 1 siteFrance
- Study dates
- 19 Nov 2016to Nov 2018
- 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 1 day to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Intubated and ventilated minors
Who may be able to join
- Patient less than 18 years old
- Patient intubated and ventilated
- intubation probe considered in place on auscultation
- SpO2> 92%
- Affiliate or entitled to a social security scheme
- No opposition of any of the parents.
Who cannot join
- Children too unstable : decompensated shock
- Spontaneous pneumothorax
- Heart massage ongoing
- Chest trauma
- Faulty position of the probe intubation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Diagnostic Qualities of Lung Ultrasonography to Monitor the Position of the Intubation Probe
The purpose of this study is to evaluate the diagnostic qualities of lung ultrasonography to monitor the position of the intubation probe.
The primary assessment criterion is of study the position of the intubation probe with two examinations carried out independently :
- sonography
- chest radiography
A correct position of the intubation probe will be considered if there is :
- Highlighting of the extremity of the intubation probe in endo tracheal
- Highlighting bilateral lung sliding
Read the detailed description
Oesophageal intubation can cause death. Selective intubation can induce a poor ventilation, hypoxemia, atelectasis etc… It's not rare in paediatric intubation. The prevalence of malposition of endotracheal tube is 30 to 40% in babies and infants less than 1 year old. Currently doctors try to detect malposition of intra-tracheal tube by auscultation and capnograms and chest radiography is needed to confirm it. The Chest X ray is the gold standard.
The aim of the study is to confirm the good positioning of the tube with a lung ultrasonography.
After each intra-tracheal intubation, for patients with qualifying criteria, a lung ultrasonography will be performed, in bed, by two trained doctors (senior and junior) to determine if the position is right. Then, the chest radiography will be performed as usual.
- Conditions
- Intubation, Intratracheal
- Being tested
- lung ultrasound
- Keywords
- Lung ultrasound, Sliding lung, Probe position
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lung ultrasoundOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the position of intubation probe by comparison between chest radiography and lung ultrasonography
correct position is defined by :
- visualization of the probe intubation extremity in endotracheal
- visualization of bilateral lung sliding
Measured: day of enrollment
Secondary outcomes (6)
Number of patients with malposition of the oesophageal or selective intubation probe
Measured: day of enrollment
Number of mobilized intubation probes
Due to inefficient ventilation and despite undetected malposition
Measured: day of enrollment
Number of malpositions of the intubation probe evaluated with lung ultrasonography by junior evaluator
Measured: day of enrollment
Number of malpositions of the intubation probe evaluated with lung ultrasonography by senior evaluator
Measured: day of enrollment
Number of malpositions of the intubation probe evaluated with a chest radiography by junior evaluator
Measured: day of enrollment
Number of malpositions of the intubation probe evaluated with a chest radiography by senior evaluator
Measured: day of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2016 (estimated)
- Study start19 Nov 2016
- Primary completionNov 2018
- Study completionNov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Intubation, IntratrachealStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 79 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
- Julie Starck, MD, Principal investigator, AP-HP, Necker hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02822846
- Sponsor's protocol ID
- 2016-04-07
- Acronym
- ECOVERA
- Status last verified
- Sep 2025
- First submitted
- 30 Jun 2016
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Knapp S, Kofler J, Stoiser B, Thalhammer F, Burgmann H, Posch M, Hofbauer R, Stanzel M, Frass M. The assessment of four different methods to verify tracheal tube placement in the critical care setting. Anesth Analg. 1999 Apr;88(4):766-70. doi: 10.1097/00000539-199904000-00016.
PubMed 10195521Harris EA, Arheart KL, Penning DH. Endotracheal tube malposition within the pediatric population: a common event despite clinical evidence of correct placement. Can J Anaesth. 2008 Oct;55(10):685-90. doi: 10.1007/BF03017744.
PubMed 18835966Schmolzer GM, O'Reilly M, Davis PG, Cheung PY, Roehr CC. Confirmation of correct tracheal tube placement in newborn infants. Resuscitation. 2013 Jun;84(6):731-7. doi: 10.1016/j.resuscitation.2012.11.028. Epub 2012 Dec 1.
PubMed 23211476Chou EH, Dickman E, Tsou PY, Tessaro M, Tsai YM, Ma MH, Lee CC, Marshall J. Ultrasonography for confirmation of endotracheal tube placement: a systematic review and meta-analysis. Resuscitation. 2015 May;90:97-103. doi: 10.1016/j.resuscitation.2015.02.013. Epub 2015 Feb 21.
PubMed 25711517Pfeiffer P, Rudolph SS, Borglum J, Isbye DL. Temporal comparison of ultrasound vs. auscultation and capnography in verification of endotracheal tube placement. Acta Anaesthesiol Scand. 2011 Nov;55(10):1190-5. doi: 10.1111/j.1399-6576.2011.02501.x. Epub 2011 Sep 8.
PubMed 22092123American College of Emergency Physicians. Clinical Policies Committee. Verification of endotracheal tube placement. Ann Emerg Med. 2002 Nov;40(5):551-2. No abstract available.
PubMed 12425285Guerder M, Maurin O, Merckx A, Foissac F, Oualha M, Renolleau S, Vedrenne-Cloquet M. Diagnostic value of pleural ultrasound to refine endotracheal tube placement in pediatric intensive care unit. Arch Pediatr. 2021 Nov;28(8):712-717. doi: 10.1016/j.arcped.2021.09.006. Epub 2021 Oct 6.
PubMed 34625381
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Diagnostic Qualities of Lung Ultrasonography to Monitor the Position of the Intubation Probe
- ClinicalTrials.gov ID
- NCT02822846
- Acronym / sponsor ID
- ECOVERA / 2016-04-07
- Conditions
- Intubation, Intratracheal
- Keywords
- Lung ultrasound, Sliding lung, Probe position
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 19 Nov 2016 (actual)
- Primary completion
- Nov 2018 (actual)
- Study completion
- Nov 2018 (actual)
- First posted
- 4 Jul 2016 (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.
The purpose of this study is to evaluate the diagnostic qualities of lung ultrasonography to monitor the position of the intubation probe.
The primary assessment criterion is of study the position of the intubation probe with two examinations carried out independently :
- sonography
- chest radiography
A correct position of the intubation probe will be considered if there is :
- Highlighting of the extremity of the intubation probe in endo tracheal
- Highlighting bilateral lung sliding
Detailed description
Oesophageal intubation can cause death. Selective intubation can induce a poor ventilation, hypoxemia, atelectasis etc… It's not rare in paediatric intubation. The prevalence of malposition of endotracheal tube is 30 to 40% in babies and infants less than 1 year old. Currently doctors try to detect malposition of intra-tracheal tube by auscultation and capnograms and chest radiography is needed to confirm it. The Chest X ray is the gold standard.
The aim of the study is to confirm the good positioning of the tube with a lung ultrasonography.
After each intra-tracheal intubation, for patients with qualifying criteria, a lung ultrasonography will be performed, in bed, by two trained doctors (senior and junior) to determine if the position is right. Then, the chest radiography will be performed as usual.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Intubated and ventilated minors
Key inclusion criteria (6 listed)
- Patient less than 18 years old
- Patient intubated and ventilated
- intubation probe considered in place on auscultation
- SpO2> 92%
- Affiliate or entitled to a social security scheme
Key exclusion criteria (5 listed)
- Children too unstable : decompensated shock
- Spontaneous pneumothorax
- Heart massage ongoing
- Chest trauma
- Faulty position of the probe intubation
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 |
|---|---|---|
| lung ultrasound | Other | – |
Primary outcome
Evaluation of the position of intubation probe by comparison between chest radiography and lung ultrasonography
Time frame: day of enrollment
correct position is defined by : * visualization of the probe intubation extremity in endotracheal * visualization of bilateral lung sliding
6 secondary outcomes
Number of patients with malposition of the oesophageal or selective intubation probe
Time frame: day of enrollment
Number of mobilized intubation probes
Time frame: day of enrollment
Number of malpositions of the intubation probe evaluated with lung ultrasonography by junior evaluator
Time frame: day of enrollment
Number of malpositions of the intubation probe evaluated with lung ultrasonography by senior evaluator
Time frame: day of enrollment
Number of malpositions of the intubation probe evaluated with a chest radiography by junior evaluator
Time frame: day of enrollment
Number of malpositions of the intubation probe evaluated with a chest radiography by senior evaluator
Time frame: day of enrollment
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 12 Sep 2025.
- Background: PubMed 10195521Knapp S, Kofler J, Stoiser B, Thalhammer F, Burgmann H, Posch M, Hofbauer R, Stanzel M, Frass M. The assessment of four different methods to verify tracheal tube placement in the critical care setting. Anesth Analg. 1999 Apr;88(4):766-70. doi: 10.1097/00000539-199904000-00016.
- Background: PubMed 18835966Harris EA, Arheart KL, Penning DH. Endotracheal tube malposition within the pediatric population: a common event despite clinical evidence of correct placement. Can J Anaesth. 2008 Oct;55(10):685-90. doi: 10.1007/BF03017744.
- Background: PubMed 23211476Schmolzer GM, O'Reilly M, Davis PG, Cheung PY, Roehr CC. Confirmation of correct tracheal tube placement in newborn infants. Resuscitation. 2013 Jun;84(6):731-7. doi: 10.1016/j.resuscitation.2012.11.028. Epub 2012 Dec 1.
- Background: PubMed 25711517Chou EH, Dickman E, Tsou PY, Tessaro M, Tsai YM, Ma MH, Lee CC, Marshall J. Ultrasonography for confirmation of endotracheal tube placement: a systematic review and meta-analysis. Resuscitation. 2015 May;90:97-103. doi: 10.1016/j.resuscitation.2015.02.013. Epub 2015 Feb 21.
- Background: PubMed 22092123Pfeiffer P, Rudolph SS, Borglum J, Isbye DL. Temporal comparison of ultrasound vs. auscultation and capnography in verification of endotracheal tube placement. Acta Anaesthesiol Scand. 2011 Nov;55(10):1190-5. doi: 10.1111/j.1399-6576.2011.02501.x. Epub 2011 Sep 8.
- Background: PubMed 12425285American College of Emergency Physicians. Clinical Policies Committee. Verification of endotracheal tube placement. Ann Emerg Med. 2002 Nov;40(5):551-2. No abstract available.
- Results publication: PubMed 34625381Guerder M, Maurin O, Merckx A, Foissac F, Oualha M, Renolleau S, Vedrenne-Cloquet M. Diagnostic value of pleural ultrasound to refine endotracheal tube placement in pediatric intensive care unit. Arch Pediatr. 2021 Nov;28(8):712-717. doi: 10.1016/j.arcped.2021.09.006. Epub 2021 Oct 6.
- Individual participant dataSharing planned: No
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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.
Julie Starck, MD principal investigator
AP-HP, Necker hospital
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 Intubation, Intratracheal, 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 6 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 12 Sep 2025. 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?
Evaluation of the position of intubation probe by comparison between chest radiography and lung ultrasonography (time frame: day of enrollment). 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 NCT02822846, which also lists 7 linked publications.
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 12 Sep 2025.