Anesthesia Intubation ComplicationNCT03920748
Evaluation of the Relationship Between Airway Measurements and Laryngoscopic View in Newborn and Infants
An observational study of Anesthesia Intubation Complication and Infant, run by Ankara Children's Health and Diseases Hematology and Oncology Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Background and Aim: The overall incidence of difficult laryngoscopy in pediatric anesthesia is lower than in adults, but this risk is higher in patients younger than one year of age. In the last decade, different measurements have been used to obtain difficult laryngoscopy markers in children. Read more about this study
- Who is it for?
- Ages Up to 24 monthsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia Intubation Complication, Infant, Newborn
- What is being tested?
- Group D and Group E
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jul 2018to 10 Jul 2019
- 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 Up to 24 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Newborn and infant age group undergoing elective surgery at Ankara Childrens' Health and Diseases Hematology Oncology Training and Research Hospital
Who may be able to join
- Newborn and infant age group
- Undergoing elective surgery requiring intubation under general anesthesia
Who cannot join
- History of congenital maxillofacial defect,
- History of upper airway pathology (tumor, cleft palate-lips, etc.)
- History of head and neck trauma (fracture, swelling, scar )
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Childrens' Health and Diseases Hematology Oncology Training and Research Hospital
Ankara, 06110
About this study
Official title: Evaluation of the Relationship Between Airway Measurements With Ultrasonography and Laryngoscopic View in Newborn and Infants
Background and Aim: The overall incidence of difficult laryngoscopy in pediatric anesthesia is lower than in adults, but this risk is higher in patients younger than one year of age. In the last decade, different measurements have been used to obtain difficult laryngoscopy markers in children. In this study, we aimed to evaluate the relationship between the airway measurements (some performed by using ultrasonography (USG)) and the difficult laryngoscopic view in neonates and infants.
Design: This is a prospective, single blinded, observational study. The number of patients was calculated as follows: A sample of 12 from the positive group (difficult laryngoscopy group) and 96 from the negative group (easy laryngoscopy group) achieve 80% power to detect a difference of 0.25 between the area under the ROC curve (AUC) under the null hypothesis of 0.50 and an AUC under the alternative hypothesis of 0,75 using a two-sided z-test at a significance level of 0.05.
Read more
Methods: All patients which is newborn and infant age group undergoing elective surgery requiring intubation under general anesthesia are assessed. Patients' age, body mass index (BMI), thyromental distance, mandibula length, the distance between the lip corner and ipsilateral ear tragus, and the transverse length (measured by hand sign-middle-ring fingers adjacent side by side) measurements are recorded. In thyromental distance measurement, "thyroid notch" are determined by USG.
The laryngoscopic view is graded by a different experienced anaesthetist who is blinded to the airway measurements.
Statistical analysis:
Receiver operating characteristic (ROC) curves are used to determine the best cut-off point for distance variables in the separation of difficult and easy laryngoscopy groups. Sensitivity, selectivity, positive predictive value and negative predictive values of lengths are calculated according to determined cut point.The difference between the two groups in terms of qualitative variables are evaluated by chi-square or Fisher's exact test. The normal distribution of the numerical variables are examined with the Shapiro-Wilk test. The difference between the two groups in terms of numerical variables are investigated by Mann Whitney U test. Values of p <0.05 are considered as statistically significant.
- Conditions
- Anesthesia Intubation Complication, Infant, Newborn
- Being tested
- Group D, Group E
- Keywords
- Difficult laryngoscopy, airway measurements, newborn, infant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group DOther
According to Cormack-Lehane (CL) Classification; laryngoscopic view grade 3-4 is defined as Group D
Group EOther
According to Cormack-Lehane (CL) Classification; laryngoscopic view grade 1-2 is defined as Group E
| Study group | Role | What they receive |
|---|---|---|
| Difficult laryngoscopy (Group D) | Glottic structures appearing during laryngoscopy are graded according to Cormack-Lehane (CL) Classification. According to this classification, patients are divided into two groups, patients with grade 3-4 are classified as difficult laryngoscopy ( Group D). Receives: Other: Group D | |
| Easy laryngoscopy (Group E) | Glottic structures appearing during laryngoscopy are graded according to Cormack-Lehane (CL) Classification. According to this classification, patients are divided into two groups, patients with grade 1-2 are classified as easy laryngoscopy ( Group E). Receives: Other: Group E |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thyromental distance (TMD)
The thyromental distance, unit of measure cm, is detected using a US linear probe with the transducer placed in the transverse plane. Thyromental distance is measured in cm as straight line from thyroid notch to lower border of mentum with head extended in all patients.
Measured: 1 hour
Other airway measurements
The other primary objective of this study is to identify if any preanesthetic airway assessment maneuvers (such as mandibula length, the distance between the lip corner and ipsilateral ear tragus, and the transverse length (measured by hand sign-middle-ring fingers adjacent side by side) measurements) would be associated with difficult laryngoscopy in newborn and infants.
Measured: 1 hour
Secondary outcomes (1)
Demographic data
The secondary objective of this study is to identify if factors such as age, sex, bady mass index (BMI) and physical status grade would be associated with grade III and IV laryngoscope views in newborn and infants.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2019
- Study start10 Jul 2018
- Primary completion10 Jul 2019
- Study completion10 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia Intubation ComplicationStudies 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
- 150 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Ankara Children's Health and Diseases Hematology and Oncology Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Feyza Sever, Ankara Children's Health and Diseases Hematology and Oncology Training and Research Hospital
- Investigators
- Feyza Sever, Principal investigator, Ankara Children's Health and Diseases Hematology and Oncology Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03920748
- Sponsor's protocol ID
- 2018105
- Status last verified
- Jan 2020
- First submitted
- 16 Apr 2019
- Last updated
- 10 Jan 2020
- 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 10 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Relationship Between Airway Measurements With Ultrasonography and Laryngoscopic View in Newborn and Infants
- ClinicalTrials.gov ID
- NCT03920748
- Acronym / sponsor ID
- 2018105
- Conditions
- Anesthesia Intubation Complication, Infant, Newborn
- Keywords
- Difficult laryngoscopy, airway measurements, newborn, infant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Ankara Children's Health and Diseases Hematology and Oncology Training and Research HospitalOther government
- Study start
- 10 Jul 2018 (actual)
- Primary completion
- 10 Jul 2019 (actual)
- Study completion
- 10 Jul 2019 (actual)
- First posted
- 19 Apr 2019 (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.
Background and Aim: The overall incidence of difficult laryngoscopy in pediatric anesthesia is lower than in adults, but this risk is higher in patients younger than one year of age. In the last decade, different measurements have been used to obtain difficult laryngoscopy markers in children. In this study, we aimed to evaluate the relationship between the airway measurements (some performed by using ultrasonography (USG)) and the difficult laryngoscopic view in neonates and infants.
Design: This is a prospective, single blinded, observational study. The number of patients was calculated as follows: A sample of 12 from the positive group (difficult laryngoscopy group) and 96 from the negative group (easy laryngoscopy group) achieve 80% power to detect a difference of 0.25 between the area under the ROC curve (AUC) under the null hypothesis of 0.50 and an AUC under the alternative hypothesis of 0,75 using a two-sided z-test at a significance level of 0.05.
Methods: All patients which is newborn and infant age group undergoing elective surgery requiring intubation under general anesthesia are assessed. Patients' age, body mass index (BMI), thyromental distance, mandibula length, the distance between the lip corner and ipsilateral ear tragus, and the transverse length (measured by hand sign-middle-ring fingers adjacent side by side) measurements are recorded. In thyromental distance measurement, "thyroid notch" are determined by USG.
The laryngoscopic view is graded by a different experienced anaesthetist who is blinded to the airway measurements.
Statistical analysis:
Receiver operating characteristic (ROC) curves are used to determine the best cut-off point for distance variables in the separation of difficult and easy laryngoscopy groups. Sensitivity, selectivity, positive predictive value and negative predictive values of lengths are calculated according to determined cut point.The difference between the two groups in terms of qualitative variables are evaluated by chi-square or Fisher's exact test. The normal distribution of the numerical variables are examined with the Shapiro-Wilk test. The difference between the two groups in terms of numerical variables are investigated by Mann Whitney U test. Values of p <0.05 are considered as statistically significant.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Difficult laryngoscopy (Group D) | – | Other: Group DGlottic structures appearing during laryngoscopy are graded according to Cormack-Lehane (CL) Classification. According to this classification, patients are divided into two groups, patients with grade 3-4 are classified as difficult laryngoscopy ( Group D). |
| Easy laryngoscopy (Group E) | – | Other: Group EGlottic structures appearing during laryngoscopy are graded according to Cormack-Lehane (CL) Classification. According to this classification, patients are divided into two groups, patients with grade 1-2 are classified as easy laryngoscopy ( Group E). |
Who may qualify
- Ages
- Up to 24 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Newborn and infant age group undergoing elective surgery at Ankara Childrens' Health and Diseases Hematology Oncology Training and Research Hospital
Key inclusion criteria (2 listed)
- Newborn and infant age group
- Undergoing elective surgery requiring intubation under general anesthesia
Key exclusion criteria (3 listed)
- History of congenital maxillofacial defect,
- History of upper airway pathology (tumor, cleft palate-lips, etc.)
- History of head and neck trauma (fracture, swelling, scar )
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 |
|---|---|---|
| Group DAccording to Cormack-Lehane (CL) Classification; laryngoscopic view grade 3-4 is defined as Group D | Other | Difficult laryngoscopy (Group D) |
| Group EAccording to Cormack-Lehane (CL) Classification; laryngoscopic view grade 1-2 is defined as Group E | Other | Easy laryngoscopy (Group E) |
Primary outcome
Thyromental distance (TMD)
Time frame: 1 hour
The thyromental distance, unit of measure cm, is detected using a US linear probe with the transducer placed in the transverse plane. Thyromental distance is measured in cm as straight line from thyroid notch to lower border of mentum with head extended in all patients.
Other airway measurements
Time frame: 1 hour
The other primary objective of this study is to identify if any preanesthetic airway assessment maneuvers (such as mandibula length, the distance between the lip corner and ipsilateral ear tragus, and the transverse length (measured by hand sign-middle-ring fingers adjacent side by side) measurements) would be associated with difficult laryngoscopy in newborn and infants.
1 secondary outcome
Demographic data
Time frame: 1 hour
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 10 Jan 2020.
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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.
Feyza Sever principal investigator
Ankara Children's Health and Diseases Hematology and Oncology Training and Research Hospital
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 Anesthesia Intubation Complication and Infant, run by Ankara Children's Health and Diseases Hematology and Oncology Training and Research Hospital at 1 site in Turkey (Türkiye).
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 2 inclusion and 3 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 10 Jan 2020. 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 Turkey (Türkiye). 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?
Thyromental distance (TMD) (time frame: 1 hour). The study lists 2 primary outcomes in all. 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 10 Jan 2020.