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Foreign Body AspirationCapnographyNCT07870005

The Impact of Preoperative Nasal Capnography on Clinical Management in Patients Undergoing Diagnostic Bronchoscopy for Suspected Foreign Body Aspiration

An observational study of Foreign Body Aspiration, run by Mersin University at 1 site in Turkey (Türkiye).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Introduction Despite advances in medical care, foreign body aspiration remains a common and ongoing health concern in children. Diagnostic bronchoscopy is the gold standard for confirming the diagnosis and providing definitive treatment. Read more about this study

Who is it for?
Ages Up to 18 years
Conditions the study is for
Foreign Body Aspiration
What is being tested?
Nasal capnographic examination
How many people
45 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Nov 2026to 1 Dec 2027
How long will I take part?
5 Days
Phase
Observational
Are there results?
Not yet: the study is under way

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 Up to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Study population: The study is planned as a single-center investigation. The study population will consist of patients presenting with foreign body aspiration to the Department of Pediatric Surgery, Faculty of Medicine, Mersin University.

Who may be able to join

  • Patients scheduled to undergo rigid bronchoscopy for foreign body aspiration at the Department of Pediatric Surgery, Mersin University Hospital, between 1 November 2026 and 1 November 2027.
  • Children aged 0-18 years.
  • Patients whose parents or legal guardians have signed the informed consent forms prepared for the study.
  • Patients for whom complete data, including nasal capnography measurements, can be collected.

Who cannot join

  • Patients presenting with foreign body aspiration outside the period from 1 November 2026 to 1 November 2027.
  • Patients who decline rigid bronchoscopy.
  • Patients whose legal guardians have not signed the informed consent forms prepared for the study.
  • Patients whose nasal capnography measurements cannot be recorded due to technical difficulties or whose other data cannot be collected in full.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Caner İsbir, Associate Professor contact

+905316014260

caner.isbir@gmail.com

Hatice Büyüköztürk Çolak, Medical Doctor contact

+905331673136

haticebuyukozturk@hotmail.com

Turkey (Türkiye)1 site
  • Department of Pediatric Surgery, Faculty of Medicine, Mersin University, Mersin, Turkey

    Mersin, Yenişehir, 33160

    Caner İsbir, Associate Professor, +905316014260, caner.isbir@gmail.com

    Hatice Büyüköztürk Çolak, Medical Doctor, +905331673136, haticebuyukozturk@hotmail.com

Other trials in Turkey (Türkiye)

About this study

Introduction Despite advances in medical care, foreign body aspiration remains a common and ongoing health concern in children. Diagnostic bronchoscopy is the gold standard for confirming the diagnosis and providing definitive treatment. However, bronchoscopy performed for suspected foreign body aspiration in children yields negative findings in 16-57% of cases. Furthermore, oxygenation problems may occur during bronchoscopy performed under general anesthesia for foreign body aspiration. Respiratory complications requiring intensive care monitoring may develop in 6.3% of patients following bronchoscopy. These risks underscore the importance of preoperative assessment. In children with suspected foreign body aspiration, preoperative nasal capnography may complement clinical and radiological findings in determining the indications for bronchoscopy and predicting potential intraoperative complications.

Capnography assesses oxygenation status by measuring end-tidal carbon dioxide concentrations. Nasal capnography is used particularly during sedation and analgesia when spontaneous breathing is maintained. In patients scheduled for diagnostic bronchoscopy for suspected foreign body aspiration, preoperative capnographic assessment may help predict complications occurring during and after the procedure.

Read more

This study aims to evaluate the association of preoperative nasal capnographic measurements with positive and negative bronchoscopic findings and potential intraoperative complications in children with foreign body aspiration.

Methods Ethical approval was obtained from the Mersin University Health Sciences Ethics Committee (2026/556). The study, including data collection, is planned to be completed within 12 months of ethical approval. The ethics application stated that an application for project funding would be submitted to the Mersin University Scientific Research Projects (BAP) Unit. The study period was specified in the ethics application as one year following approval by the BAP Unit. Data collection will commence after the nasal capnography device has been procured through the project.

Children aged 0-18 years undergoing rigid bronchoscopy for foreign body aspiration at the Department of Pediatric Surgery, Mersin University Hospital, during the specified study period will be eligible for inclusion. Patients operated on by Associate Professor Caner İsbir, Dr. Hatice Büyüköztürk Çolak, or Dr. Mert Jundi will be included. All investigators will participate in data collection, and the collected data will be analyzed by Associate Professor Caner İsbir and Dr. Hatice Büyüköztürk Çolak.

Patients presenting with foreign body aspiration during the study period will be excluded if they decline rigid bronchoscopy, if their legal guardians do not sign the study-specific informed consent forms, or if nasal capnographic measurements cannot be recorded because of technical difficulties.

In patients admitted to the pediatric surgery ward with suspected foreign body aspiration, end-tidal carbon dioxide (ETCO₂) will be measured using a capnography device connected to a nasal cannula during preoperative preparation on the ward, before rigid bronchoscopy. Measurements will be recorded numerically for each patient. ETCO₂ values will also be classified into two groups: values up to and including the 35-45 mmHg range and values above this range.

The following variables will be assessed: age, sex, body weight, weight percentiles, preoperative pulse oximetry readings, preoperative clinical symptoms, physical examination findings, radiological findings, and postoperative complications following bronchoscopy. Patients will be categorized into three age groups: 0-6, 6-12, and 12-18 years.

The associations between nasal capnographic measurements and positive or negative bronchoscopic findings, as well as intraoperative and postoperative complications, will be examined. Independent-samples t-tests and chi-square tests will be used to assess the associations of preoperative capnographic measurements with bronchoscopic findings and intraoperative and postoperative complications. Logistic regression analysis will additionally be used to examine the associations of nasal capnographic measurements within the specified age groups with positive or negative bronchoscopic findings and intraoperative and postoperative complications.

Read the detailed description

Introduction Despite advances in diagnosis and treatment, foreign body aspiration remains a common and clinically relevant health problem among children. The mortality rate associated with foreign body aspiration in children has been reported to range from 1% to 5%. Diagnostic bronchoscopy remains the gold standard for confirming the diagnosis of foreign body aspiration and providing definitive treatment. In clinical practice, indications for bronchoscopy are determined based on the history provided by the family, physical examination findings, and radiological investigations. However, 16%-57% of bronchoscopies performed in children with suspected foreign body aspiration may result in negative exploration. Furthermore, among children presenting to the emergency department with a history suggestive of foreign body aspiration, 27% have no respiratory symptoms and 20% have no abnormal physical examination findings. During bronchoscopy performed under general anesthesia for foreign body aspiration, respiratory distress and oxygenation problems may also occur because of inflammation, secretions, or granulation tissue caused by the foreign body. Consequently, post-bronchoscopy respiratory complications requiring intensive care monitoring may develop in 6.3% of patients. Given these risks, the use of scoring systems based on preprocedural physical examination and radiological findings to determine bronchoscopy indications remains an active area of research.

For these reasons, in addition to determining the indication for bronchoscopy based on the available clinical and radiological findings, predicting potential intraoperative complications appears to be important in children with suspected foreign body aspiration. Accordingly, assessing both the likelihood of a positive bronchoscopy and the adequacy of ventilation before the procedure may improve the safety of bronchoscopy in these patients.

Capnography enables the noninvasive assessment of ventilation by measuring end-tidal carbon dioxide levels in intubated patients receiving mechanical ventilation. Nasal capnography is used particularly during procedures performed under sedation and analgesia in which spontaneous breathing is maintained, allowing respiratory depression and associated hypercapnia to be detected and thereby improving procedural safety. A particular advantage of nasal capnography is its ability to identify mild hypercapnia that may not be reflected by pulse oximetry, as well as to facilitate the early detection of serious respiratory compromise. Therefore, preprocedural nasal capnographic assessment in patients scheduled to undergo diagnostic bronchoscopy for suspected foreign body aspiration may help predict potential intraoperative complications and facilitate appropriate preparation for interventions such as respiratory support. Taken together, these considerations suggest that the noninvasive assessment of ventilatory status using nasal capnography before bronchoscopy may be a clinically relevant parameter for both improving procedural safety and predicting positive bronchoscopic findings in children with suspected foreign body aspiration.

This study aimed to evaluate the associations of preprocedural nasal capnographic assessment with positive and negative bronchoscopic exploration findings and with intraoperative complications in children undergoing bronchoscopy for suspected foreign body aspiration.

Methods Approval was obtained from the Mersin University Health Sciences Ethics Committee (2026/556). The study, including the data collection phase, is planned to be completed within 12 months following the date of ethics committee approval. The ethics committee application indicated that an application would be submitted to the Mersin University Scientific Research Projects (BAP) Unit for funding. In the ethics committee application, the study period was defined as one year following approval by the BAP Unit. Data collection will commence after the nasal capnography device has been procured within the scope of the project.

Children aged 0-18 years who are scheduled to undergo rigid bronchoscopy for suspected foreign body aspiration at the Department of Pediatric Surgery of Mersin University Hospital during the specified study period are planned to be included. Patients undergoing procedures performed by Assoc. Prof. Caner İsbir, Dr. Hatice Büyüköztürk Çolak, or Dr. Mert Jundi during the data collection period will be considered for inclusion. Data collection will be conducted with the participation of all investigators. The collected data will be analyzed by Assoc. Prof. Caner İsbir and Dr. Hatice Büyüköztürk Çolak.

Patients presenting with suspected foreign body aspiration whose legal guardians decline rigid bronchoscopy, those whose legal guardians do not sign the informed consent forms prepared for the study, and those whose nasal capnographic measurements cannot be recorded because of technical problems will be excluded from the study.

In patients admitted to the pediatric surgery ward with suspected foreign body aspiration, end-tidal carbon dioxide (ETCO₂) levels will be measured using a capnography device connected to a nasal cannula during preoperative preparation in the ward before rigid bronchoscopy. The measurements will be recorded numerically for each patient. ETCO₂ values will also be categorized into two groups: values within the range of 35-45 mmHg and values above this range.

The variables to be evaluated will include age, sex, body weight, weight-for-age percentile, preoperative pulse oximetry values, preoperative clinical symptoms, physical examination findings, radiological findings, and postoperative complications following bronchoscopy. Patients will be divided into three age groups: 0-6, 6-12, and 12-18 years. In addition, the associations between nasal capnographic measurements and positive or negative bronchoscopic exploration findings, intraoperative complications, and postoperative complications will be investigated.

The associations of positive or negative bronchoscopic exploration findings and intraoperative/postoperative complications with preoperative capnographic assessment results will be analyzed using the independent-samples t test and chi-square test, as appropriate. Furthermore, logistic regression analysis will be performed to evaluate the associations between nasal capnographic measurements in the specified age groups and positive or negative bronchoscopic exploration findings, as well as intraoperative and postoperative complications.

Being tested
Nasal capnographic examination
Keywords
Foreign body aspiration, bronchoscopy, capnography, predictive value, children, complications
Medical subject headings
Respiratory Aspiration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nasal capnographic examinationDiagnostic test

    Measurement of end-tidal carbon dioxide levels using a nasal capnography device.

Study groups in NCT07870005
Study groupRoleWhat they receive
Children with foreign body aspirationChildren with foreign body aspiration
Receives: Diagnostic Test: Nasal capnographic examination

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Measurement of end-tidal carbon dioxide levels using a nasal capnography device

    Measurement of end-tidal carbon dioxide levels using a nasal capnography device

    Measured: From enrollment to the end of treatment at one weeks

  2. Enhancing safety in diagnostic bronchoscopy for foreign body aspiration in children

    Enhancing the safety of bronchoscopy performed for suspected foreign body aspiration in children.

    Measured: From enrollment to the end of treatment at one weeks

Secondary outcomes (1)
  1. Changes during a postoperative follow-up period averaging one week in patients undergoing diagnostic bronchoscopy for suspected foreign body aspiration.

    The effects of whether end-tidal carbon dioxide values measured using nasal capnography in the study participants exceed the reference range of 35-45 mmHg on treatment management will be evaluated.

    Measured: From November 2026 to November 2027

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Oct 2026
  2. Study start1 Nov 2026 (estimated)
  3. Primary completion1 Nov 2027 (estimated)
  4. Study completion1 Dec 2027 (estimated)

Resources

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
Cross-sectional
Enrolment
45 participants (estimated)
Target duration
5 Days
IDs, dates and publications
ClinicalTrials.gov ID
NCT07870005
Sponsor's protocol ID
2026/556
Acronym
Capnography
Status last verified
Oct 2026
First submitted
6 Oct 2026
Last updated
15 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Vargo JJ, Zuccaro G Jr, Dumot JA, Conwell DL, Morrow JB, Shay SS. Automated graphic assessment of respiratory activity is superior to pulse oximetry and visual assessment for the detection of early respiratory depression during therapeutic upper endoscopy. Gastrointest Endosc. 2002 Jun;55(7):826-31. doi: 10.1067/mge.2002.124208.

    PubMed 12024135
  • Turk D, Moslehi MA, Hosseinpour H. Role of Flexible Fiberoptic Bronchoscopy in the Diagnosis and Treatment of Pediatric Airway Foreign Bodies: A 5-Year Experience at a Tertiary Care Hospital in Iran. Tanaffos. 2022 Mar;21(3):354-361.

    PubMed 37025307
  • Acharya K. Rigid Bronchoscopy in Airway Foreign Bodies: Value of the Clinical and Radiological Signs. Int Arch Otorhinolaryngol. 2016 Jul;20(3):196-201. doi: 10.1055/s-0036-1584293. Epub 2016 May 30.

    PubMed 27413398
  • Friedrich-Rust M, Welte M, Welte C, Albert J, Meckbach Y, Herrmann E, Kannengiesser M, Trojan J, Filmann N, Schroeter H, Zeuzem S, Bojunga J. Capnographic monitoring of propofol-based sedation during colonoscopy. Endoscopy. 2014 Mar;46(3):236-44. doi: 10.1055/s-0033-1359149. Epub 2013 Dec 11.

    PubMed 24338242
  • Nagler J, Krauss B. Capnography: a valuable tool for airway management. Emerg Med Clin North Am. 2008 Nov;26(4):881-97, vii. doi: 10.1016/j.emc.2008.08.005.

    PubMed 19059088
  • Ozyuksel G, Arslan UE, Boybeyi-Turer O, Tanyel FC, Soyer T. New scoring system to predict foreign body aspiration in children. J Pediatr Surg. 2020 Aug;55(8):1663-1666. doi: 10.1016/j.jpedsurg.2019.12.015. Epub 2019 Dec 30.

    PubMed 31952682
  • Golan-Tripto I, Mezan DW, Tsaregorodtsev S, Stiler-Timor L, Dizitzer Y, Goldbart A, Aviram M. From rigid to flexible bronchoscopy: a tertiary center experience in removal of inhaled foreign bodies in children. Eur J Pediatr. 2021 May;180(5):1443-1450. doi: 10.1007/s00431-020-03914-y. Epub 2021 Jan 3.

    PubMed 33389071
  • Kiyan G, Gocmen B, Tugtepe H, Karakoc F, Dagli E, Dagli TE. Foreign body aspiration in children: the value of diagnostic criteria. Int J Pediatr Otorhinolaryngol. 2009 Jul;73(7):963-7. doi: 10.1016/j.ijporl.2009.03.021. Epub 2009 Apr 24.

    PubMed 19394092
  • Foltran F, Ballali S, Rodriguez H, Sebastian van As AB, Passali D, Gulati A, Gregori D. Inhaled foreign bodies in children: a global perspective on their epidemiological, clinical, and preventive aspects. Pediatr Pulmonol. 2013 Apr;48(4):344-51. doi: 10.1002/ppul.22701. Epub 2012 Nov 20.

    PubMed 23169545
  • Markov S, Markova P, Karavelikova I, Halacheva H. Foreign Bodies in Lower Airway in Children: Brief Review and Clinical Experience. Children (Basel). 2025 Jan 7;12(1):67. doi: 10.3390/children12010067.

    PubMed 39857898

Questions about this trial

What is this clinical trial studying?

An observational study of Foreign Body Aspiration, run by Mersin University at 1 site in Turkey (Türkiye).

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 4 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: opening soon, as of the sponsor's last update on 15 Oct 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 Turkey (Türkiye). 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Caner İsbir, Associate Professor (+905316014260, caner.isbir@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Measurement of end-tidal carbon dioxide levels using a nasal capnography device (time frame: From enrollment to the end of treatment at one weeks). The study lists 2 primary outcomes in all. 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 NCT07870005, which also lists 10 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 15 Oct 2026.

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