Difficult IntubationNCT04361929
Pediatric Difficult Airway Prediction Using Ultrasonography
An observational study of Difficult Intubation and Difficult Mask Ventilation, run by Cairo University at 1 site in Egypt.
Trial summary
Recognition of difficult airway is purported to be the most important factor in successful management of difficult airway. The incidence of difficult airway in pediatrics is much less than in adults; however, airway related complications can lead to hypoxic brain damage or even death especially in younger age groups… Read more about this study
- Who is it for?
- Ages 1 month to 10 years
- Conditions the study is for
- Difficult Intubation, Difficult Mask Ventilation
- What is being tested?
- Ultrasound
- Type of treatment
- Medical device
- How many people
- 584 participants
- Where
- 1 siteEgypt
- Study dates
- 26 Apr 2020to 15 May 2022
- 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 month to 10 years
- All sexes
- No healthy volunteers
- Child
Study population: A total of 584 consecutive pediatric patients, aged one month-10 years scheduled for elective surgery under general anesthesia will be included in the study.
Who may be able to join
- Gender both males and females
- ASA Class I and II
- Age 1month to 10 years
- Children undergoing elective surgery under general anaesthesia
Who cannot join
- congenital upper airway malformation,
- head and neck swellings,
- scars,
- radiation to the neck,
- tracheotomy,
- Neurosurgical or cardiac procedures
- ENT surgeries
Trial locations and contacts
1 site in 1 country.
About this study
Recognition of difficult airway is purported to be the most important factor in successful management of difficult airway. The incidence of difficult airway in pediatrics is much less than in adults; however, airway related complications can lead to hypoxic brain damage or even death especially in younger age groups as neonates and infants.The aim of this work is to evaluate the feasibility and accuracy of ultrasound measurements (hyomental distances, tongue measurements, and anterior neck soft tissue thickness at the level of hyoid bone, thyrohyoid membrane, and thyroid cartilage) in predicting difficult laryngoscopy and difficult mask ventilation in pediatric patients undergoing elective surgery under general anesthesia.
- Conditions
- Difficult Intubation, Difficult Mask Ventilation
- Being tested
- Ultrasound
- Keywords
- Difficult airway, pediatric, Airway ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDevice
The following ultrasound measurements will be assessed: DS-HB, HMDR, TT, TT-S, TW, EW, ET, DS-E, and DS-V.
What is being measured
The primary outcome is the main question the study is designed to answer.
The sensitivity of DS-HB to predict difficult laryngoscopy
The ability of DS-HB ultrasound measurement to predict difficult airway in pediatrics
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start26 Apr 2020
- Primary completion10 May 2022
- Study completion15 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Difficult IntubationStudies of the same condition, open and under way.
- More trials run by Cairo 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
- 584 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heba Nassar,MD, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04361929
- Sponsor's protocol ID
- MS-259-2019
- Status last verified
- Jul 2022
- First submitted
- 22 Apr 2020
- Last updated
- 20 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Difficult Airway Prediction Using Ultrasonography
- ClinicalTrials.gov ID
- NCT04361929
- Acronym / sponsor ID
- MS-259-2019
- Conditions
- Difficult Intubation, Difficult Mask Ventilation
- Keywords
- Difficult airway, pediatric, Airway ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 584 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 26 Apr 2020 (actual)
- Primary completion
- 10 May 2022 (actual)
- Study completion
- 15 May 2022 (actual)
- First posted
- 24 Apr 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.
Recognition of difficult airway is purported to be the most important factor in successful management of difficult airway. The incidence of difficult airway in pediatrics is much less than in adults; however, airway related complications can lead to hypoxic brain damage or even death especially in younger age groups as neonates and infants.The aim of this work is to evaluate the feasibility and accuracy of ultrasound measurements (hyomental distances, tongue measurements, and anterior neck soft tissue thickness at the level of hyoid bone, thyrohyoid membrane, and thyroid cartilage) in predicting difficult laryngoscopy and difficult mask ventilation in pediatric patients undergoing elective surgery under general anesthesia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 month to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- A total of 584 consecutive pediatric patients, aged one month-10 years scheduled for elective surgery under general anesthesia will be included in the study.
Key inclusion criteria (4 listed)
- Gender both males and females
- ASA Class I and II
- Age 1month to 10 years
- Children undergoing elective surgery under general anaesthesia
Key exclusion criteria (7 listed)
- congenital upper airway malformation,
- head and neck swellings,
- scars,
- radiation to the neck,
- tracheotomy,
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 |
|---|---|---|
| UltrasoundThe following ultrasound measurements will be assessed: DS-HB, HMDR, TT, TT-S, TW, EW, ET, DS-E, and DS-V. | Device | – |
Primary outcome
The sensitivity of DS-HB to predict difficult laryngoscopy
Time frame: 30 minutes
The ability of DS-HB ultrasound measurement to predict difficult airway in pediatrics
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 20 Jul 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Difficult Intubation and Difficult Mask Ventilation, run by Cairo 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 4 inclusion and 7 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 20 Jul 2022. 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?
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?
The sensitivity of DS-HB to predict difficult laryngoscopy (time frame: 30 minutes). 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 20 Jul 2022.