- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07349953
Correlation Between Anthropometric Characteristics and Age-based Formulas for Uncuffed Pediatric Endotracheal Tube
Estimation of Correlation Betweeen Antropometric Characteristics of Children up to 8 Years and Age-based Formulas for Uncuffed Endotracheal Tube in Elective Intubated Children During General Anesthesia
Study Overview
Status
Conditions
Detailed Description
Patients who met inclusion criteria entered the study. All included patients were premedicated with midazolam 0.1mg/kg IV 30 minutes before general anesthesia. Induction: propofol 2,5mg/kg IV, rocuronium 0,6mg/kg IV, fentanyl 3mcg/kg IV; maintenance: sevoflurane 1vol% - 2vol%, fentanyl 3mcg/kg IV as needed. reversion of neuromuscular block was achieved using sugammadex. Trachea was intubated using direct laryngoscopy. Intubation performed one anesthesiologist with more than 10 years of clinical experience in pediatric anesthesia. Initial choice of endotracheal tube (ET) was based on the size of little finger. Proper position of ET was confirmed with chest auscultation, capnography and capnometry. If placing ET was difficult or air leak was not detected using inspiratory pressure > 25cmH2O,ET was replaced with 0,5mm smaller one. If there was air leak using inspiratory pressure < 10 mmHg ET was replaced with 0.5mm bigger one. All children were ventilated using protective strategy. After intubation, measures were made:
- Finger's circumference was measured with flexible ruler tape (in millimeters). The tape was wrapped around the base of the finger. Circumferences of index finger, middle finger, ring finger and small finger were documented for each hand.
- Data of body weight, body height and body mass index were taken from patients history.
- Sizes of used endotracheal tubes were documented.
- Calculations of ET tube size using age based formulas were made:
for children over 2 years ID (mm) = god/4+4 for children under 2 years of age ODcal (mm) = 0,00223x age(days)+4.88
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Belgrade, Serbia, 11000
- Institute for mother and child health care
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age up to 8 years of age;
- Children without congenital and acquired anomalies of the trachea;
- Children in whom tracheal intubation is planned as part of the anesthesia plan
Exclusion Criteria:
- Age over 8 years of age;
- The presence of congenital and acquired anomalies of the trachea;
- Children who are already intubated; and failure to obtain informed consent
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Peditric patients up to 8 years of age requiuring general anesthesia with endotracheal intubation
All patients were scheduled for surgery and elective intubation.
Patient's body weight, height, body mass index, and finger circumference were documented.
The tube size was selected based on an appropriate formula.
After intubation, the circumference of the index, middle, ring, and little fingers of the right and left hands, as well as the child's body mass and height, were measured.
The measurement was performed using a flexible meter at the joint of the palm and the root of the finger.
Only one anesthesiologist performed the intubation.
If the placement of the tube was difficult or there was no audible air leakage around the tube at an inspiratory pressure > 20cmH2O, the selected tube was replaced with a smaller tube by 0.5 mm.
If an audible air leak was documented after intubation at an inspiratory pressure of < 10 mmHg, the tube was replaced with a larger tube by 0.5 mm.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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The primary outcome of the study was determining the correlation between the size of the selected tube and the circumference of the little finger of the right and left hand
Time Frame: Day 1
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Day 1
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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determining the correlation between the size of the selected tube and the circumference of the index finger of the right and left hand
Time Frame: Day 1
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Day 1
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determining the correlation between the size of the selected tube and the circumference of the middle finger of the right and left hand
Time Frame: Day 1
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Day 1
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Determining the correlation between the size of the selected tube and the circumference of the ring finger of the right and left hand
Time Frame: Day 1
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Day 1
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determining the correlation between the size of the selected tube and body weight
Time Frame: Day 1
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Day 1
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determining the correlation between the size of the selected tube and body height
Time Frame: Day 1
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Day 1
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Determining the frequency of post-treatment complications of hoarseness, cough and sore throat
Time Frame: Day 1
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Day 1
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determining the frequency of reintubation
Time Frame: Day 1
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Day 1
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Collaborators and Investigators
Publications and helpful links
General Publications
- Park S, Shin SW, Kim HJ, Byeon GJ, Yoon JU, Kim EJ, Kim HY. Choice of the correct size of endotracheal tube in pediatric patients. Anesth Pain Med (Seoul). 2022 Oct;17(4):352-360. doi: 10.17085/apm.22215. Epub 2022 Oct 26.
- Zhou M, Xu WY, Xu S, Zang QL, Li Q, Tan L, Hu YC, Ma N, Xia JH, Liu K, Ye M, Pu FY, Chen L, Song LJ, Liu Y, Jiang L, Gu L, Zou Z. Prediction of endotracheal tube size in pediatric patients: Development and validation of machine learning models. Front Pediatr. 2022 Oct 20;10:970646. doi: 10.3389/fped.2022.970646. eCollection 2022.
- Hanamoto H, Maegawa H, Inoue M, Oyamaguchi A, Kudo C, Niwa H. Age-based prediction of uncuffed tracheal tube size in children to prevent inappropriately large tube selection: a retrospective analysis. BMC Anesthesiol. 2019 Aug 7;19(1):141. doi: 10.1186/s12871-019-0818-3.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 8/148
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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