Trial no.:	PACTR202607757431479	Date of Registration:	17/07/2026
Trial Status:	Retrospective registration - This trial was registered after enrolment of the first participant

TRIAL DESCRIPTION

Public title

Airway ultrasound compared to age-based formula for detection the appropriate endotracheal tube size in pediatric patients undergoing upper endoscopy

Official scientific title

Airway ultrasound compared to age-based formula for detection the appropriate endotracheal tube size in pediatric patients undergoing upper endoscopy

Brief summary describing the background and objectives of the trial

Comparing airway ultrasound to the age-based formula for detection the appropriate endotracheal tube size, using a cufflator in recurrently intubated pediatric patients undergoing upper endoscopy Choosing the appropriate size of an endotracheal tube (ETT) during intubation is a key to ensuring appropriate ventilation while minimizing airway trauma in children. If a very small ETT is inserted, there is a risk of inadequate ventilation and decreased reliability of end tidal carbon dioxide monitoring. There is also a risk of air leakage, anesthetic gas leakage, aspiration, and high airway resistance Similarly, a very large ETT may cause serious complications including airway damage, such as ulceration, local ischemia, scar formation, post-intubation croup, and, in severe cases, subglottic stenosis Airway ultrasound is starting to gain attention in assisting endotracheal intubation, especially in young infants. It can also be used to select ETT size Ultrasonography (USG) is a good predictor of correct cuffed ETT sizes. They reported that USG is more reliable for assessing the subglottic diameter in a pediatric airway and predicted the appropriate ETT sizeAim of the Work our aim is Comparing airway ultrasound to the age-based formula for detection the appropriate endotracheal tube size, using a cufflator in recurrently intubated pediatric patients undergoing upper endoscopy. better than aged-based formulas for cuffed tubes

Type of trial

RCT

Acronym (If the trial has an acronym then please provide)

Disease(s) or condition(s) being studied

Paediatrics

Sub-Disease(s) or condition(s) being studied

Purpose of the trial

Early detection /Screening

Anticipated trial start date

04/04/2025

Actual trial start date

04/04/2025

Anticipated date of last follow up

06/05/2026

Actual Last follow-up date

06/05/2026

Anticipated target sample size (number of participants)

84

Actual target sample size (number of participants)

84

Recruitment status

Active, not recruiting

Publication URL

Secondary Ids	Issuing authority/Trial register

STUDY DESIGN
Intervention assignment	Allocation to intervention	If randomised, describe how the allocation sequence was generated	Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms	Masking	If masking / blinding was used
Crossover: all participants receive all interventions in different sequence during study	Randomised	Simple randomization using a randomization table from a statistics book	Allocation Sequence/Code was not concealed	Masking/blinding used	Care giver/Provider

INTERVENTIONS
Intervention type	Intervention name	Dose	Duration	Intervention description	Group size	Nature of control
Control Group	ETT US GUIDED		3 MIN	Intravenous access will be secured for the administration of fluids and drugs, administration of 0.05 mg/kg midazolam, 1.5 mg/kg lidocaine as a premedication 5 minute before induction, induction of anesthesia was applied with 1.5 mg/kg Propofol, 2 μg/kg fentanyl (9). Participants will be mask ventilated with sevoflurane at a minimal alveolar concentration (MAC) of 1.2 in oxygen for 3 minutes. After induction of anesthesia, the subglottic diameter will be estimated with the ultrasonic probe (linear probe, Sonosite-Nano max ultrasound system, Bothell-USA). The subglottic diameter will be measured after 3 min of induction begin with the location of the true vocal cords, seen as paired hyperechoic linear structures,	42	Active-Treatment of Control Group
Experimental Group	ETI age dependent	no dose	3 min	While in the age-based formula group (Group I I), the ETT with the nearest ID as predicted by the age-based formula will be chosen for endotracheal intubation.	42

ELIGIBILITY CRITERIA
List inclusion criteria	List exclusion criteria	Age Category	Minimum age	Maximum age	Gender
1. Pediatric ≤10 years old both sexes required cuffed ETT. 2. ASA I, II or III. 3. Patients Scheduled for elective upper endoscopy with previous history of multiple upper endoscopy for follow up esophageal varices or for esophageal dilatation.	1. Legal Guardian refusal to participate in the study. 2. Any anatomical deformity of upper airway, previous surgery involving upper airway and any obvious scars, mass or ulcer in the neck which will interfere with the ultrasound examination	Child: 6 Year-12 Year,Infant: 1 Month(s)-12 Month(s),Infant: 13 Month(s)-24 Month(s),New born: 0 Day-1 Month,Preschool Child: 2 Year-5 Year	1 Year(s)	10 Year(s)	Both

ETHICS APPROVAL

Has the study received appropriate ethics committee approval

Date the study will be submitted for approval

Date of approval

Name of the ethics committee

Yes

04/04/2025

Menofia university

Ethics Committee Address
Street address	City	Postal code	Country
shibien elkom	menofia	32511	Egypt

OUTCOMES
Type of outcome	Outcome	Timepoint(s) at which outcome measured
Primary Outcome	o And size will be considered as small if it equilibrates to <10 cmH2O after 10s. 4-If the tube size is small or large, it will be changed to next ETT by 0.5mm difference and leak test will be repeated to confirm the appropriate size (10). Primary outcome: The number of the patient with appropriate ETT size in both groups	after intubation
Secondary Outcome	1- The internal diameter of the ETT from the age-based formula ABF, ETT size determined by ultrasound imaging and the size of ETT that the participant was intubated with. 2- HR (beat/min) and MAP. 3- EtCO2. 4- Tracheal leak inflation pressure using a cufflator. 5- Amount of used anesthetic agent. 6- Post extubation complication ex: laryngeal edema (croup) or stridor. 7- Recovery assesses by modified Aldrete score. 8- Patient and endoscopist satisfaction. 9- Ultrasound data.	at end of operation

RECRUITMENT CENTRES
Name of recruitment centre	Street address	City	Postal code	Country
national liver institute	shibien l kom	menofia	32511	Egypt

FUNDING SOURCES
Name of source	Street address	City	Postal code	Country
national liver institute	shibien el kom	menofia	32511	Egypt

SPONSORS
Sponsor level	Name	Street address	City	Postal code	Country	Nature of sponsor
Primary Sponsor	national liver institute	shibien elkom	menofia	32511	Egypt	University

COLLABORATORS
Name	Street address	City	Postal code	Country

CONTACT PEOPLE
Role	Name	Email	Phone	Street address
Principal Investigator	mariam rizk	mariamrizk.mr@gmail.com	+201021145353	shiibien el kom
City	Postal code	Country	Position/Affiliation
menofia	32511	Egypt	national liver institute
Role	Name	Email	Phone	Street address
Public Enquiries	ghada mahmoud	dr.ghadamahmoud84@gmail.com	+201024595554	quesna
City	Postal code	Country	Position/Affiliation
menofia	32511	Egypt	NLI
Role	Name	Email	Phone	Street address
Scientific Enquiries	eman sayed	emansayed825@gmail.com	+201024595554	shibien el kom
City	Postal code	Country	Position/Affiliation
menofia	32511	Egypt	NLI

REPORTING
Share IPD	Description	Additional Document Types	Sharing Time Frame	Key Access Criteria
Yes	Data Availability and Type: De-identified, anonymized individual participant data (IPD) resulting from this randomized controlled trial will be made available upon reasonable request to promote open science and collaborative public health research. The dataset consists of objective quantitative clinical measurements and qualitative categorical outcomes collected prospectively. De-identification and Ethical Compliance: To strictly adhere to WHO patient privacy guidelines and ethical standards, the dataset will be fully anonymized. All direct and indirect personal identifiers (including patient names, hospital record numbers, exact admission dates, and legal guardians’ identifying information) will be completely omitted or scrubbed to prevent any risk of re-identification.	Informed Consent Form,Statistical Analysis Plan,Study Protocol	STUDY from 4/2025 to 6/2026	Baseline & Demographic Data: Age (years), sex, and ASA physical status classification (I, II, or III) for pediatric patients (\le10 years old) undergoing elective upper endoscopy. Interventional Parameters: Individual quantitative ultrasound measurements of the subglottic diameter (transverse air column diameter at the cricoid cartilage) for Group I, and age-based Motoyama formula internal diameter calculations for Group II. Primary Outcome: Categorical evaluation of endotracheal tube (ETT) size appropriateness (Appropriate/Optimal, Too Large, or Too Small) verified systematically via the air leak test and circuit pressure equilibration. Secondary & Safety Outcomes:
URL	Results Available	Results Summary	Result Posting Date	First Journal Publication Date
PACTR	No
Result Upload 1:	Result Upload 2:	Result Upload 3:	Result Upload 4:	Result Upload 5:

Result URL Hyperlinks	Link To Protocol
Result URL Hyperlinks

Changes to trial information
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Trial Information	Trial description	24/02/2026	COMMENT OF THE REVIEWER	Comparing airway ultrasound to the age-based formula for detection the appropriate endotracheal tube size, using a cufflator in recurrently intubated pediatric patients undergoing upper endoscopy	Comparing airway ultrasound to the age-based formula for detection the appropriate endotracheal tube size, using a cufflator in recurrently intubated pediatric patients undergoing upper endoscopy Choosing the appropriate size of an endotracheal tube (ETT) during intubation is a key to ensuring appropriate ventilation while minimizing airway trauma in children. If a very small ETT is inserted, there is a risk of inadequate ventilation and decreased reliability of end tidal carbon dioxide monitoring. There is also a risk of air leakage, anesthetic gas leakage, aspiration, and high airway resistance Similarly, a very large ETT may cause serious complications including airway damage, such as ulceration, local ischemia, scar formation, post-intubation croup, and, in severe cases, subglottic stenosis Airway ultrasound is starting to gain attention in assisting endotracheal intubation, especially in young infants. It can also be used to select ETT size
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Trial Information	Trial description	02/07/2026	reviewer comment	Comparing airway ultrasound to the age-based formula for detection the appropriate endotracheal tube size, using a cufflator in recurrently intubated pediatric patients undergoing upper endoscopy Choosing the appropriate size of an endotracheal tube (ETT) during intubation is a key to ensuring appropriate ventilation while minimizing airway trauma in children. If a very small ETT is inserted, there is a risk of inadequate ventilation and decreased reliability of end tidal carbon dioxide monitoring. There is also a risk of air leakage, anesthetic gas leakage, aspiration, and high airway resistance Similarly, a very large ETT may cause serious complications including airway damage, such as ulceration, local ischemia, scar formation, post-intubation croup, and, in severe cases, subglottic stenosis Airway ultrasound is starting to gain attention in assisting endotracheal intubation, especially in young infants. It can also be used to select ETT size	Comparing airway ultrasound to the age-based formula for detection the appropriate endotracheal tube size, using a cufflator in recurrently intubated pediatric patients undergoing upper endoscopy Choosing the appropriate size of an endotracheal tube (ETT) during intubation is a key to ensuring appropriate ventilation while minimizing airway trauma in children. If a very small ETT is inserted, there is a risk of inadequate ventilation and decreased reliability of end tidal carbon dioxide monitoring. There is also a risk of air leakage, anesthetic gas leakage, aspiration, and high airway resistance Similarly, a very large ETT may cause serious complications including airway damage, such as ulceration, local ischemia, scar formation, post-intubation croup, and, in severe cases, subglottic stenosis Airway ultrasound is starting to gain attention in assisting endotracheal intubation, especially in young infants. It can also be used to select ETT size Ultrasonography (USG) is a good predictor of correct cuffed ETT sizes. They reported that USG is more reliable for assessing the subglottic diameter in a pediatric airway and predicted the appropriate ETT sizeAim of the Work our aim is Comparing airway ultrasound to the age-based formula for detection the appropriate endotracheal tube size, using a cufflator in recurrently intubated pediatric patients undergoing upper endoscopy. better than aged-based formulas for cuffed tubes
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Eligibility	Age group	02/07/2026	reviewer comment	Child: 6 Year-12 Year	New born: 0 Day-1 Month, Infant: 13 Month(s)-24 Month(s), Infant: 1 Month(s)-12 Month(s), Preschool Child: 2 Year-5 Year, Child: 6 Year-12 Year
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Ethics	Ethics List	02/07/2026	reviewer comment	TRUE, Menofia university, shibien elkom, menofia, 32511, Egypt, , 04 Apr 2025, +201024595554, dr.ghadamahmoud84@gmail.com, 39851_38031_4737.pdf	TRUE, Menofia university, shibien elkom, menofia, 32511, Egypt, , 04 Apr 2025, +201024595554, medcine@menofia.edu.eg, 39851_38031_4737.pdf
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Reporting	IPD description	02/07/2026	reviewer comment	each patient has indvidualized data recorded	in patient departement each patient has indvidualized data recorded
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Reporting	IPD description	11/07/2026	reviewers comment	in patient departement each patient has indvidualized data recorded	Data Availability and Type: De-identified, anonymized individual participant data (IPD) resulting from this randomized controlled trial will be made available upon reasonable request to promote open science and collaborative public health research. The dataset consists of objective quantitative clinical measurements and qualitative categorical outcomes collected prospectively. De-identification and Ethical Compliance: To strictly adhere to WHO patient privacy guidelines and ethical standards, the dataset will be fully anonymized. All direct and indirect personal identifiers (including patient names, hospital record numbers, exact admission dates, and legal guardians’ identifying information) will be completely omitted or scrubbed to prevent any risk of re-identification.
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Reporting	Key access criteria	11/07/2026	REVIEWER COMMENT	primary outcome	Baseline & Demographic Data: Age (years), sex, and ASA physical status classification (I, II, or III) for pediatric patients (\le10 years old) undergoing elective upper endoscopy. Interventional Parameters: Individual quantitative ultrasound measurements of the subglottic diameter (transverse air column diameter at the cricoid cartilage) for Group I, and age-based Motoyama formula internal diameter calculations for Group II. Primary Outcome: Categorical evaluation of endotracheal tube (ETT) size appropriateness (Appropriate/Optimal, Too Large, or Too Small) verified systematically via the air leak test and circuit pressure equilibration. Secondary & Safety Outcomes:
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Reporting	IPD URL	02/07/2026	reviewer comment		academic
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Reporting	IPD URL	11/07/2026	REVIEWER COMMENT	academic	PACTR
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Reporting	Study protocol document	02/07/2026	reviewer comment	Study Protocol, Statistical Analysis Plan, Informed Consent Form, Clinical Study Report, Analytic Code	Study Protocol, Statistical Analysis Plan, Informed Consent Form

Pan African Clinical Trials Registry