Airway Complication of AnesthesiaNCT06443424
Assessment of Pediatric Challenging Airway
An observational study of Airway Complication of Anesthesia, run by Zagazig University at 1 site in Egypt.
Trial summary
The goal of these Observational study is to learn about pediatric airway the main question to answer is: 1-Is using point-of-care ultrasound provide an easy, early, and accurate preoperative assessment of the challenging pediatric airway and the endotracheal tube sizing more than traditional methods. Read more about this study
- Who is it for?
- Ages 1 year to 4 yearsHealthy volunteers can take part
- Conditions the study is for
- Airway Complication of Anesthesia
- What is being tested?
- ultrasound device
- Type of treatment
- Medical device
- How many people
- 101 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Jul 2024to 1 Oct 2025
- How long will I take part?
- 1 Day
- 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 4 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: pediatric population
Who may be able to join
- Patient's parents' consent.
- Age:from one to 4 years old.
- Both sexes (male and female).
- BMI with in (5-85%) of body mass index of the child birth of same age and sex.
- Physical status: American Society of Anesthesiologists (ASA) physical status I and II.
- Type of operation: elective surgery under general anesthesia with endotracheal intubation
Who cannot join
- Pre-existing airway malformations or pathology like facial or cervical fracture
- Deformity of the airway anatomy [by masses or tumors].
- Pathology of the airway [edema, burn and arthritis].
- Anticipated difficult airway
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Medicine
Zagazig, Sharqia Province, 44511
heba elshair, M.B, B.Ch, +201064157744 ext. 002, hebaelshair558@GMAIL.COM
About this study
Official title: Preoperative Assessment of Pediatric Challenging Airway and Endotracheal Tube Sizing Using Point-of-Care Ultrasound Versus Traditional Methods in Elective Surgeries
The goal of these Observational study is to learn about pediatric airway the main question to answer is:
1-Is using point-of-care ultrasound provide an easy, early, and accurate preoperative assessment of the challenging pediatric airway and the endotracheal tube sizing more than traditional methods.
- Conditions
- Airway Complication of Anesthesia
- Being tested
- ultrasound device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound deviceDevice
usage of ultrasound device in pediatric airway asessment
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimation of tube size using point of care ultrasound compared to age formula in pediatric population
estimate tubal size by ultasound parameters;distance from the skin to the anterior part of the trachea at the hyoid level (ANS-hyoid), The Anterior Neck Soft Tissue Thickness at the level of the vocal Cords. (ANS-VC), The pre - epiglottic space (Pre-E ), the distance from the epiglottis to the mid - point of the distance between the vocal cords (E-VC) , The subglottic transverse diameter and compare with age formula in pediatric
Measured: pre induction
Secondary outcomes (2)
Determine the accuracy of point of care ultrasound in assessing challenging pediatric airway
determine the accuracy of point of care ultrasound in assessing challenging pediatric airway in correlation to Cormack Lehane grading in pediatric patients
Measured: pre induction
Record any obstacles that may interfere with the ultrasound
● To record any obstacles that may interfere with the ultrasound assessment such as: acoustic, anatomic , optical illusion artifact.
Measured: during opeartion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2024
- Study start25 Jul 2024 (estimated)
- Primary completion5 Jan 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Airway Complication of AnesthesiaStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe 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
- 101 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Heba Helmy Elshair, Zagazig University
- Investigators
- heba elshair, M.B, B.Ch, Principal investigator, Anesthesia, Intensive care and Pain Managment Department, Faculty of medicine, Zagazig university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06443424
- Sponsor's protocol ID
- pocus in pediatric airway
- Status last verified
- Jun 2024
- First submitted
- 30 May 2024
- Last updated
- 28 Jun 2024
- Results posted
- No
- Individual data sharing
- Yes
Publications
Santillanes G, Gausche-Hill M. Pediatric airway management. Emerg Med Clin North Am. 2008 Nov;26(4):961-75, ix. doi: 10.1016/j.emc.2008.08.004.
PubMed 19059095Brambrink AM, Braun U. Airway management in infants and children. Best Pract Res Clin Anaesthesiol. 2005 Dec;19(4):675-97. doi: 10.1016/j.bpa.2005.07.002.
PubMed 16408541Litman RS, McDonough JM, Marcus CL, Schwartz AR, Ward DS. Upper airway collapsibility in anesthetized children. Anesth Analg. 2006 Mar;102(3):750-4. doi: 10.1213/01.ane.0000197695.24281.df.
PubMed 16492823Krishna SG, Bryant JF, Tobias JD. Management of the Difficult Airway in the Pediatric Patient. J Pediatr Intensive Care. 2018 Sep;7(3):115-125. doi: 10.1055/s-0038-1624576. Epub 2018 Jan 28.
PubMed 31073483Mirghassemi A, Soltani AE, Abtahi M. Evaluation of laryngoscopic views and related influencing factors in a pediatric population. Paediatr Anaesth. 2011 Jun;21(6):663-7. doi: 10.1111/j.1460-9592.2011.03555.x. Epub 2011 Mar 14.
PubMed 21401798Lee SU, Jung JY, Kim DK, Kwak YH, Kwon H, Cho JH, Park JW, Choi YJ. New decision formulas for predicting endotracheal tube depth in children: analysis of neck CT images. Emerg Med J. 2018 May;35(5):303-308. doi: 10.1136/emermed-2017-206795. Epub 2018 Feb 6.
PubMed 29437848Lin J, Bellinger R, Shedd A, Wolfshohl J, Walker J, Healy J, Taylor J, Chao K, Yen YH, Tzeng CT, Chou EH. Point-of-Care Ultrasound in Airway Evaluation and Management: A Comprehensive Review. Diagnostics (Basel). 2023 Apr 25;13(9):1541. doi: 10.3390/diagnostics13091541.
PubMed 37174933Pan S, Lin C, Tsui BCH. Neonatal and paediatric point-of-care ultrasound review. Australas J Ultrasound Med. 2022 Oct 13;26(1):46-58. doi: 10.1002/ajum.12322. eCollection 2023 Feb.
PubMed 36960139Sotoodehnia M, Khodayar M, Jalali A, Momeni M, Safaie A, Abdollahi A. Prediction of difficult laryngoscopy / difficult intubation cases using upper airway ultrasound measurements in emergency department: a prospective observational study. BMC Emerg Med. 2023 Jul 25;23(1):78. doi: 10.1186/s12873-023-00852-4.
PubMed 37491186Sutagatti JG, Raja R, Kurdi MS. Ultrasonographic Estimation of Endotracheal Tube Size in Paediatric Patients and its Comparison with Physical Indices Based Formulae: A Prospective Study. J Clin Diagn Res. 2017 May;11(5):UC05-UC08. doi: 10.7860/JCDR/2017/25905.9838. Epub 2017 May 1.
PubMed 28658880
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Assessment of Pediatric Challenging Airway and Endotracheal Tube Sizing Using Point-of-Care Ultrasound Versus Traditional Methods in Elective Surgeries
- ClinicalTrials.gov ID
- NCT06443424
- Acronym / sponsor ID
- pocus in pediatric airway
- Conditions
- Airway Complication of Anesthesia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 101 participants (estimated)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 25 Jul 2024 (estimated)
- Primary completion
- 5 Jan 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 5 Jun 2024 (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.
The goal of these Observational study is to learn about pediatric airway the main question to answer is:
1-Is using point-of-care ultrasound provide an easy, early, and accurate preoperative assessment of the challenging pediatric airway and the endotracheal tube sizing more than traditional methods.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 1 year to 4 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- pediatric population
Key inclusion criteria (6 listed)
- Patient's parents' consent.
- Age:from one to 4 years old.
- Both sexes (male and female).
- BMI with in (5-85%) of body mass index of the child birth of same age and sex.
- Physical status: American Society of Anesthesiologists (ASA) physical status I and II.
Key exclusion criteria (4 listed)
- Pre-existing airway malformations or pathology like facial or cervical fracture
- Deformity of the airway anatomy [by masses or tumors].
- Pathology of the airway [edema, burn and arthritis].
- Anticipated difficult airway
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 |
|---|---|---|
| ultrasound deviceusage of ultrasound device in pediatric airway asessment | Device | – |
Primary outcome
Estimation of tube size using point of care ultrasound compared to age formula in pediatric population
Time frame: pre induction
estimate tubal size by ultasound parameters;distance from the skin to the anterior part of the trachea at the hyoid level (ANS-hyoid), The Anterior Neck Soft Tissue Thickness at the level of the vocal Cords. (ANS-VC), The pre - epiglottic space (Pre-E ), the distance from the epiglottis to the mid - point of the distance between the vocal cords (E-VC) , The subglottic transverse diameter and compare with age formula in pediatric
2 secondary outcomes
Determine the accuracy of point of care ultrasound in assessing challenging pediatric airway
Time frame: pre induction
Record any obstacles that may interfere with the ultrasound
Time frame: during opeartion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2024.
- Background: PubMed 19059095Santillanes G, Gausche-Hill M. Pediatric airway management. Emerg Med Clin North Am. 2008 Nov;26(4):961-75, ix. doi: 10.1016/j.emc.2008.08.004.
- Background: PubMed 16408541Brambrink AM, Braun U. Airway management in infants and children. Best Pract Res Clin Anaesthesiol. 2005 Dec;19(4):675-97. doi: 10.1016/j.bpa.2005.07.002.
- Background: PubMed 16492823Litman RS, McDonough JM, Marcus CL, Schwartz AR, Ward DS. Upper airway collapsibility in anesthetized children. Anesth Analg. 2006 Mar;102(3):750-4. doi: 10.1213/01.ane.0000197695.24281.df.
- Background: PubMed 31073483Krishna SG, Bryant JF, Tobias JD. Management of the Difficult Airway in the Pediatric Patient. J Pediatr Intensive Care. 2018 Sep;7(3):115-125. doi: 10.1055/s-0038-1624576. Epub 2018 Jan 28.
- Background: PubMed 21401798Mirghassemi A, Soltani AE, Abtahi M. Evaluation of laryngoscopic views and related influencing factors in a pediatric population. Paediatr Anaesth. 2011 Jun;21(6):663-7. doi: 10.1111/j.1460-9592.2011.03555.x. Epub 2011 Mar 14.
- Background: PubMed 29437848Lee SU, Jung JY, Kim DK, Kwak YH, Kwon H, Cho JH, Park JW, Choi YJ. New decision formulas for predicting endotracheal tube depth in children: analysis of neck CT images. Emerg Med J. 2018 May;35(5):303-308. doi: 10.1136/emermed-2017-206795. Epub 2018 Feb 6.
- Background: PubMed 37174933Lin J, Bellinger R, Shedd A, Wolfshohl J, Walker J, Healy J, Taylor J, Chao K, Yen YH, Tzeng CT, Chou EH. Point-of-Care Ultrasound in Airway Evaluation and Management: A Comprehensive Review. Diagnostics (Basel). 2023 Apr 25;13(9):1541. doi: 10.3390/diagnostics13091541.
- Background: PubMed 36960139Pan S, Lin C, Tsui BCH. Neonatal and paediatric point-of-care ultrasound review. Australas J Ultrasound Med. 2022 Oct 13;26(1):46-58. doi: 10.1002/ajum.12322. eCollection 2023 Feb.
- Background: PubMed 37491186Sotoodehnia M, Khodayar M, Jalali A, Momeni M, Safaie A, Abdollahi A. Prediction of difficult laryngoscopy / difficult intubation cases using upper airway ultrasound measurements in emergency department: a prospective observational study. BMC Emerg Med. 2023 Jul 25;23(1):78. doi: 10.1186/s12873-023-00852-4.
- Background: PubMed 28658880Sutagatti JG, Raja R, Kurdi MS. Ultrasonographic Estimation of Endotracheal Tube Size in Paediatric Patients and its Comparison with Physical Indices Based Formulae: A Prospective Study. J Clin Diagn Res. 2017 May;11(5):UC05-UC08. doi: 10.7860/JCDR/2017/25905.9838. Epub 2017 May 1.
- Individual participant dataSharing planned: Yes
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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.
heba elshair, M.B, B.Ch principal investigator
Anesthesia, Intensive care and Pain Managment Department, Faculty of medicine, Zagazig 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 Airway Complication of Anesthesia, run by Zagazig University at 1 site in Egypt.
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 6 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: status not confirmed, as of the sponsor's last update on 28 Jun 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact heba elshair, M.B, B.Ch (+201064157744 ext. 002, hebaelshair558@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimation of tube size using point of care ultrasound compared to age formula in pediatric population (time frame: pre induction). 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 NCT06443424, 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 28 Jun 2024.