Congenital Heart DiseaseNCT04814888
3D Airway Model for Pediatric Patients
An observational study of Congenital Heart Disease, run by Pusan National University Yangsan Hospital at 1 site in South Korea.
Trial summary
To determine the correct size of endotracheal tubes (ETT) for endotracheal intubation of pediatric patients is no menial task. Although new methods have been investigated to determine ETT size, and the three-dimensional (3D) printing technology has been successful in the field of surgery, there are not many studies in… Read more about this study
- Who is it for?
- Ages Up to 5 years
- Conditions the study is for
- Congenital Heart Disease
- What is being tested?
- intubation with a cuffed ETT by a printed 3D airway model
- How many people
- 35 participants
- Where
- 1 siteSouth Korea
- Study dates
- 3 Sep 2019to 16 Mar 2020
- 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 Up to 5 years
- All sexes
- No healthy volunteers
- Child
Study population: We enrolled children under 6 years of age (range 4 days to 61 months) scheduled for surgery for congenital heart disease with chest computed tomography (CT) images including upper airways from September 3, 2019, to March, 16, 2020. Pediatric patients with congenital heart disease were chosen because they usually keep their ETT with mechanical ventilation in the intensive care unit and also have relatively high risk of complication associated with ETT comparing to healthy patients. Therefore, we think it is more important to select appropriate size of ETT in pediatric patients with congenital heart disease.
Who may be able to join
- children under 6 years of age (range 4 days to 61 months) scheduled for surgery for congenital heart disease with chest computed tomography (CT) images including upper airways
Who cannot join
- pediatric patients with intubation or tracheostomy before general anesthesia due to underlying disease
- small sized airway with inner diameter <3.0 mm because of pre-term or low birth weight
- unstable vital signs during induction
- history of difficult intubation
- emergency surgery where printing a 3D airway model in advance was not possible
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prediction of Endotracheal Tube Size Using a Printed Three-dimensional Airway Model in Pediatric Patients With Congenital Heart Disease: a Prospective, Single-center, Single- Group Study
To determine the correct size of endotracheal tubes (ETT) for endotracheal intubation of pediatric patients is no menial task. Although new methods have been investigated to determine ETT size, and the three-dimensional (3D) printing technology has been successful in the field of surgery, there are not many studies in the field of anesthesia. The purpose of this study is to evaluate the accuracy of a 3D airway model for prediction of the correct ETT size, and compare the results with a conventional age-based formula in pediatric patients.
Read the detailed description
To determine the correct size of endotracheal tubes (ETT) for endotracheal intubation of pediatric patients is no menial task. Although new methods have been investigated to determine ETT size, and the three-dimensional (3D) printing technology has been successful in the field of surgery, there are not many studies in the field of anesthesia. The purpose of this study is to evaluate the accuracy of a 3D airway model for prediction of the correct ETT size, and compare the results with a conventional age-based formula in pediatric patients. : Thirty five pediatric patients under 6 years of age who were scheduled for congenital heart surgery. In the pre-anaesthetic period, the patient's computed tomography (CT) images were converted to STL files using the 3D conversion program. An FDM type 3D printer was used to print 3D airway models from the sub-glottis to the upper carina. ETT size was selected by inserting various sized cuffed-ETTs to a printed 3D airway model.
- Conditions
- Congenital Heart Disease
- Being tested
- intubation with a cuffed ETT by a printed 3D airway model
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intubation with a cuffed ETT by a printed 3D airway modelOther
Two anaesthesiologists unaware of patient's demographic data such as patient's height, weight, and age predicted and recorded ETT size by inserting various sized cuffed-ETTs (MallinckrodtTM Hi-Lo tracheal tube, Covidien, Ireland) to a printed 3D airway model. If the diameter of trachea undersized, air leak around ETT can occur. In that case, we can use that ETT after inflating the pilot balloon with small amount of air. Standard monitoring (non-invasive blood pressure measurement, electrocardiogram, and pulse oximetry) was applied to pediatric patients in the operating room and general anesthesia was induced with ketamine 1 mg/kg and rocuronium 0.6 mg/kg and maintained with sevoflurane. After intubation with a cuffed ETT by a printed 3D airway model was finished, an air leak test was performed by one of three anaesthesiologists dedicated to pediatric cardiac anesthesia.
What is being measured
The primary outcome is the main question the study is designed to answer.
ETT size prediction by the printed 3D airway model
The reliability of ETT size prediction by the printed 3D airway model was compared with the results of the age-based formula.
Measured: during anesthesia induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study start3 Sep 2019
- Primary completion16 Mar 2020
- Study completion16 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- 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
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pusan National University Yangsan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kim Hee Young, Pusan National University Yangsan Hospital
- Investigators
- Hee Young Kim, Principal investigator, Department of Anesthesia and Pain Medicine, School of Medicine, Pusan National University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04814888
- Sponsor's protocol ID
- 05-2019-116
- Status last verified
- Aug 2024
- First submitted
- 22 Mar 2021
- Last updated
- 12 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Endotracheal Tube Size Using a Printed Three-dimensional Airway Model in Pediatric Patients With Congenital Heart Disease: a Prospective, Single-center, Single- Group Study
- ClinicalTrials.gov ID
- NCT04814888
- Acronym / sponsor ID
- 05-2019-116
- Conditions
- Congenital Heart Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Pusan National University Yangsan HospitalUniversity, hospital or other
- Study start
- 3 Sep 2019 (actual)
- Primary completion
- 16 Mar 2020 (actual)
- Study completion
- 16 Mar 2020 (actual)
- First posted
- 24 Mar 2021 (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.
To determine the correct size of endotracheal tubes (ETT) for endotracheal intubation of pediatric patients is no menial task. Although new methods have been investigated to determine ETT size, and the three-dimensional (3D) printing technology has been successful in the field of surgery, there are not many studies in the field of anesthesia. The purpose of this study is to evaluate the accuracy of a 3D airway model for prediction of the correct ETT size, and compare the results with a conventional age-based formula in pediatric patients.
Detailed description
To determine the correct size of endotracheal tubes (ETT) for endotracheal intubation of pediatric patients is no menial task. Although new methods have been investigated to determine ETT size, and the three-dimensional (3D) printing technology has been successful in the field of surgery, there are not many studies in the field of anesthesia. The purpose of this study is to evaluate the accuracy of a 3D airway model for prediction of the correct ETT size, and compare the results with a conventional age-based formula in pediatric patients. : Thirty five pediatric patients under 6 years of age who were scheduled for congenital heart surgery. In the pre-anaesthetic period, the patient's computed tomography (CT) images were converted to STL files using the 3D conversion program. An FDM type 3D printer was used to print 3D airway models from the sub-glottis to the upper carina. ETT size was selected by inserting various sized cuffed-ETTs to a printed 3D airway model.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- We enrolled children under 6 years of age (range 4 days to 61 months) scheduled for surgery for congenital heart disease with chest computed tomography (CT) images including upper airways from September 3, 2019, to March, 16, 2020. Pediatric patients with congenital heart disease were chosen because they usually keep their ETT with mechanical ventilation in the intensive care unit and also have relatively high risk of complication associated with ETT comparing to healthy patients. Therefore, we think it is more important to select appropriate size of ETT in pediatric patients with congenital heart disease.
Key inclusion criteria (1 listed)
- children under 6 years of age (range 4 days to 61 months) scheduled for surgery for congenital heart disease with chest computed tomography (CT) images including upper airways
Key exclusion criteria (5 listed)
- pediatric patients with intubation or tracheostomy before general anesthesia due to underlying disease
- small sized airway with inner diameter <3.0 mm because of pre-term or low birth weight
- unstable vital signs during induction
- history of difficult intubation
- emergency surgery where printing a 3D airway model in advance was not possible
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 |
|---|---|---|
| intubation with a cuffed ETT by a printed 3D airway modelTwo anaesthesiologists unaware of patient's demographic data such as patient's height, weight, and age predicted and recorded ETT size by inserting various sized cuffed-ETTs (MallinckrodtTM Hi-Lo tracheal tube, Covidien, Ireland) to a printed 3D airway model. If the diameter of trachea undersized, air leak around ETT can occur. In that case, we can use that ETT after inflating the pilot balloon with small amount of air. Standard monitoring (non-invasive blood pressure measurement, electrocardiogram, and pulse oximetry) was applied to pediatric patients in the operating room and general anesthesia was induced with ketamine 1 mg/kg and rocuronium 0.6 mg/kg and maintained with sevoflurane. After intubation with a cuffed ETT by a printed 3D airway model was finished, an air leak test was performed by one of three anaesthesiologists dedicated to pediatric cardiac anesthesia. | Other | – |
Primary outcome
ETT size prediction by the printed 3D airway model
Time frame: during anesthesia induction
The reliability of ETT size prediction by the printed 3D airway model was compared with the results of the age-based formula.
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 Aug 2024.
- 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.
Hee Young Kim principal investigator
Department of Anesthesia and Pain Medicine, School of Medicine, Pusan National University
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 Congenital Heart Disease, run by Pusan National University Yangsan Hospital at 1 site in South Korea.
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 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 Aug 2024. 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 South Korea. 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?
ETT size prediction by the printed 3D airway model (time frame: during anesthesia induction). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Aug 2024.