AirwayNCT04533334
Measurement of the Distances of the Lower Airway in Pediatric Population
An observational study of Airway and Child, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
Pediatric patients are exposed to increased risk during general anesthesia. A myriad of problems can be encountered in the pediatric population by misplaced endotracheal tubes. Especially, during one-lung ventilation (OLV) a right-sided or left-sided tube is inserted to facilitate the surgery. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- What is being tested?
- FOB measurement
- Type of treatment
- Surgery or procedure
- How many people
- 299 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Jan 2019to 9 Jan 2021
- 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 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: All patients undergoing general anesthesia via an endotracheal tube will be eligible for recruitment.
Who may be able to join
- All patients undergoing general anesthesia via an endotracheal tube
- ASA I-III
Who cannot join
- Patients that do not meet age criteria
- Uncontrolled asthma or hyper reactive airway
- hypoxemia, previous thoracic surgery
- ASA > III
- Unstable hemodynamics
- Patients with tracheal or oral malignancies
Show all 9Show fewer
- Patients with face trauma
- Informed consent not given
- using a tube with a number too small for the fiberoptic bronchoscope to pass through
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University-Cerrahpasa
Istanbul, 34098
About this study
Official title: Measurement of the Distance Between the Orifice of the Right Upper Lobe and Carinae and Labium Oris With Fiberoptic Bronchoscopy in Pediatric Population in Turkey
Pediatric patients are exposed to increased risk during general anesthesia. A myriad of problems can be encountered in the pediatric population by misplaced endotracheal tubes. Especially, during one-lung ventilation (OLV) a right-sided or left-sided tube is inserted to facilitate the surgery. However, inadvertent tube use, caused by misinterpretation of the distances of the trachea and the main bronchi, may cause unintended hypoxemia, postoperative atelectasis and even mortality.
In this study, investigators will measure the distance between distal margin of right lung upper lobe orifice-carina and carina-lip with the help of fiberoptic bronchoscopy (FOB).
Read the detailed description
In ASA-PS I-II-III children between 1-18 years of age who are orotracheally intubated for any reason, the fiber optic bronchoscope will be advanced in the tube and first the carina distance and then the carina to right upper bronchus distance will be measured.
Age, weight, height, body mass index (BMI), weight percentile, height percentile, comorbidities, ASA score, tube size, lip margin distance, right upper bronchus to carina distance and right upper lobe to carina distance/ Carina to-lip margin ratio will be recorded.
- Being tested
- FOB measurement
- Keywords
- anesthesia, fiberoptic bronchoscopy, lower airway anatomy, child, right upper lobe bronchus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FOB measurementProcedure or surgery
A FOB will be inserted after anesthesia induction and the distances will be measured by direct observation via the bronchoscope.
| Study group | Role | What they receive |
|---|---|---|
| Pediatric | FOB measurement of the distance between carina and right upper lobe bronchus and carina and labium oris in pediatric population Receives: Procedure: FOB measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper/Lower Airway Ratio
Ratio of the distance between labium oris to carina and carina to right upper lobe orifice
Measured: 1 day
Secondary outcomes (1)
Correlation between patient characteristics and distances measured by FOB
Correlation between age, body mass index, gender, percentiles and the distance between labium oris to carina and carina to right upper lobe orifice
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2020
- Study start9 Jan 2019
- Primary completion9 Jan 2021
- Study completion9 Jan 2021
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 AirwayStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 299 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kadir Melih YILMAZ, Istanbul University - Cerrahpasa
- Investigators
- PINAR Kendigelen, MD, Study director, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04533334
- Sponsor's protocol ID
- 26082020
- Status last verified
- May 2023
- First submitted
- 26 Aug 2020
- Last updated
- 3 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data available on reasonable request
Publications
Rudraraju P, Eisen LA. Confirmation of endotracheal tube position: a narrative review. J Intensive Care Med. 2009 Sep-Oct;24(5):283-92. doi: 10.1177/0885066609340501. Epub 2009 Aug 3.
PubMed 19654121
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of the Distance Between the Orifice of the Right Upper Lobe and Carinae and Labium Oris With Fiberoptic Bronchoscopy in Pediatric Population in Turkey
- ClinicalTrials.gov ID
- NCT04533334
- Acronym / sponsor ID
- 26082020
- Keywords
- anesthesia, fiberoptic bronchoscopy, lower airway anatomy, child, right upper lobe bronchus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 299 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 9 Jan 2019 (actual)
- Primary completion
- 9 Jan 2021 (actual)
- Study completion
- 9 Jan 2021 (actual)
- First posted
- 31 Aug 2020 (actual)
- 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.
Pediatric patients are exposed to increased risk during general anesthesia. A myriad of problems can be encountered in the pediatric population by misplaced endotracheal tubes. Especially, during one-lung ventilation (OLV) a right-sided or left-sided tube is inserted to facilitate the surgery. However, inadvertent tube use, caused by misinterpretation of the distances of the trachea and the main bronchi, may cause unintended hypoxemia, postoperative atelectasis and even mortality.
In this study, investigators will measure the distance between distal margin of right lung upper lobe orifice-carina and carina-lip with the help of fiberoptic bronchoscopy (FOB).
Detailed description
In ASA-PS I-II-III children between 1-18 years of age who are orotracheally intubated for any reason, the fiber optic bronchoscope will be advanced in the tube and first the carina distance and then the carina to right upper bronchus distance will be measured.
Age, weight, height, body mass index (BMI), weight percentile, height percentile, comorbidities, ASA score, tube size, lip margin distance, right upper bronchus to carina distance and right upper lobe to carina distance/ Carina to-lip margin ratio will be recorded.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric | – | Procedure: FOB measurementFOB measurement of the distance between carina and right upper lobe bronchus and carina and labium oris in pediatric population |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- All patients undergoing general anesthesia via an endotracheal tube will be eligible for recruitment.
Key inclusion criteria (2 listed)
- All patients undergoing general anesthesia via an endotracheal tube
- ASA I-III
Key exclusion criteria (9 listed)
- Patients that do not meet age criteria
- Uncontrolled asthma or hyper reactive airway
- hypoxemia, previous thoracic surgery
- ASA > III
- Unstable hemodynamics
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 |
|---|---|---|
| FOB measurementA FOB will be inserted after anesthesia induction and the distances will be measured by direct observation via the bronchoscope. | Procedure or surgery | Pediatric |
Primary outcome
Upper/Lower Airway Ratio
Time frame: 1 day
Ratio of the distance between labium oris to carina and carina to right upper lobe orifice
1 secondary outcome
Correlation between patient characteristics and distances measured by FOB
Time frame: 1 day
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 3 May 2023.
- Background: PubMed 19654121Rudraraju P, Eisen LA. Confirmation of endotracheal tube position: a narrative review. J Intensive Care Med. 2009 Sep-Oct;24(5):283-92. doi: 10.1177/0885066609340501. Epub 2009 Aug 3.
- Individual participant dataSharing planned: Undecided. Data available on reasonable request
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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.
PINAR Kendigelen, MD study director
Istanbul University - Cerrahpasa
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 Airway and Child, run by Istanbul University - Cerrahpasa 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 2 inclusion and 9 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 3 May 2023. 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?
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?
Upper/Lower Airway Ratio (time frame: 1 day). 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 NCT04533334, 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 3 May 2023.