Difficult IntubationNCT03641157
Predicting Difficult Airway in Children
An observational study of Difficult Intubation and Pediatrics, run by Tepecik Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Background: Obtaining airway security holds the utmost importance in anesthesia. Specific predictive tests or findings for difficult airway are not defined for various pediatric age groups. Anthropometric measurements are defined parallel to percentile curves in different age groups. Read more about this study
- Who is it for?
- Ages 1 month to 36 months
- Conditions the study is for
- Difficult Intubation, Pediatrics
- What is being tested?
- Easy Intubation
- Type of treatment
- Injection or infusion
- How many people
- 108 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Jul 2014to 11 Jul 2016
- 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 36 months
- All sexes
- Child
Study population: Demographic data, head circumference, weight, height measurements, body mass index and percentile values were recorded by a pediatric surgeon who was unaware about the studyin the preoperative period.
Who may be able to join
- 0-3 years old (1-36 mounts) pediatric patients
- Patients 0-3 age years old with ASA I, undergoing elective surgery were included in this study
Who cannot join
- Patients with known syndrome, facial anomaly, ASA score above 2 and laryngeal mask aiway were excluded from the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Value of BMI and Anthropometric Measurements With CL Test in Predicting Difficult Laryngoscopy in Children
Background: Obtaining airway security holds the utmost importance in anesthesia. Specific predictive tests or findings for difficult airway are not defined for various pediatric age groups. Anthropometric measurements are defined parallel to percentile curves in different age groups.
Aim: The aim of this study is to find out the value of body mass index and anthropometric measurements in prediction of difficult laryngoscopy in children by comparing to direct laryngoscopic evaluation of Cormack-Lehane test.
Read more
Methods: Following institutional ethics committee approval and informed consent of parents of 108 patients (ages 0-3years), undergoing elective surgery were included in this study. Weight, height, body mass index and head circumference of the patients were measured and percentiles were recorded, prior to induction.
Following standard anesthesia induction with thiopental all patients received 0,6 mg.kg-1 rocuronium intravenously. After sufficient time for neuromuscular relaxation laryngoscopy performed and Cormack-Lehane scores recorded. All recorded parameters were compared with Cormack-Lehane scores.
- Conditions
- Difficult Intubation, Pediatrics
- Being tested
- Easy Intubation
- Keywords
- Difficult intubation, Pediatrics, predictive tests
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Easy IntubationOther
Also called Difficult intubation
| Study group | Role | What they receive |
|---|---|---|
| Group I Easy Intubation | Pediatric patients ages 0-3 years Easy Intubation (Cormach-Lehane score I-II) Receives: Other: Easy Intubation | |
| Group II Difficult intubation | Pediatric patients ages 0-3 years Difficult intubation (Cormach-Lehane score III-IV) Receives: Other: Easy Intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difficult laryngoscopy classification using Cormack-LehaneGrade Assessment of difficult laryngoscopy at the time of the airway management procedure.
Classified as Grade I-visualization of entire laryngeal aperture, grade II-visualization of only posterior commissure of laryngeal aperture, grade III-visualization of only epiglottis, grade IV-visualization of just the soft palate.
Measured: immediate
Secondary outcomes (5)
Head circumference measured in cm with a measuring tape.
Head circumference were taken at the level above eyebrows and ears and measured in cm with a measuring tape.
Measured: immediate
Weight measured in kilogram with electronic scale.
Weight measured using electronic scale (0-20 kg) while undressed and without diapers .
Measured: immediate
Height measured in cm with infantometer.
Height measured using a portable infantometer (0-100 cm) while the child was in supine position.
Measured: immediate
BMI was calculated as kg/m2.
BMI measured using a weight/height2 formul
Measured: immediate
Percentage values measured in % with percentile tables.
Percentage (%) values using from the percentile tables of Turkish children were determined after the head circumference (cm), height (cm), weight (kg) and BMI (kg/m2) values of all pediatric cases were determined as described above.
Measured: immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2018
- Study start11 Jul 2014
- Primary completion11 Jul 2016
- Study completion11 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Difficult IntubationStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tepecik Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GAYE AYDIN, Tepecik Training and Research Hospital
- Investigators
- PERVIN BOZKURT, Prof, Study director, Tepecik Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03641157
- Sponsor's protocol ID
- GAYDIN
- Status last verified
- Aug 2018
- First submitted
- 31 Mar 2018
- Last updated
- 21 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Value of BMI and Anthropometric Measurements with CL Test in Predicting Difficult Laryngoscopy in Children
Publications
Heinrich S, Birkholz T, Ihmsen H, Irouschek A, Ackermann A, Schmidt J. Incidence and predictors of difficult laryngoscopy in 11,219 pediatric anesthesia procedures. Paediatr Anaesth. 2012 Aug;22(8):729-36. doi: 10.1111/j.1460-9592.2012.03813.x. Epub 2012 Feb 20.
PubMed 22340664Heinrich S, Birkholz T, Ihmsen H, Irouschek A, Ackermann A, Cesnjevar R, Schmidt J. Incidence and predictors of poor laryngoscopic view in children undergoing pediatric cardiac surgery. J Cardiothorac Vasc Anesth. 2013 Jun;27(3):516-21. doi: 10.1053/j.jvca.2012.08.019. Epub 2012 Oct 17.
PubMed 23083795Inal MT, Memis D, Sahin SH, Gunday I. [Comparison of different tests to determine difficult intubation in pediatric patients]. Rev Bras Anestesiol. 2014 Nov-Dec;64(6):391-4. doi: 10.1016/j.bjan.2014.02.001. Epub 2014 Aug 28. Portuguese.
PubMed 25437694Mansano AM, Modolo NS, Silva LM, Ganem EM, Braz LG, Knabe Ade C, Freitas FM. Bedside tests to predict laryngoscopic difficulty in pediatric patients. Int J Pediatr Otorhinolaryngol. 2016 Apr;83:63-8. doi: 10.1016/j.ijporl.2016.01.031. Epub 2016 Feb 3.
PubMed 26968055Mirghassemi 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 21401798
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Value of BMI and Anthropometric Measurements With CL Test in Predicting Difficult Laryngoscopy in Children
- ClinicalTrials.gov ID
- NCT03641157
- Acronym / sponsor ID
- GAYDIN
- Conditions
- Difficult Intubation, Pediatrics
- Keywords
- Difficult intubation, Pediatrics, predictive tests
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Tepecik Training and Research HospitalUniversity, hospital or other
- Study start
- 11 Jul 2014 (actual)
- Primary completion
- 11 Jul 2016 (actual)
- Study completion
- 11 Jul 2016 (actual)
- First posted
- 21 Aug 2018 (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: Obtaining airway security holds the utmost importance in anesthesia. Specific predictive tests or findings for difficult airway are not defined for various pediatric age groups. Anthropometric measurements are defined parallel to percentile curves in different age groups.
Aim: The aim of this study is to find out the value of body mass index and anthropometric measurements in prediction of difficult laryngoscopy in children by comparing to direct laryngoscopic evaluation of Cormack-Lehane test.
Methods: Following institutional ethics committee approval and informed consent of parents of 108 patients (ages 0-3years), undergoing elective surgery were included in this study. Weight, height, body mass index and head circumference of the patients were measured and percentiles were recorded, prior to induction.
Following standard anesthesia induction with thiopental all patients received 0,6 mg.kg-1 rocuronium intravenously. After sufficient time for neuromuscular relaxation laryngoscopy performed and Cormack-Lehane scores recorded. All recorded parameters were compared with Cormack-Lehane scores.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I Easy Intubation | – | Other: Easy IntubationPediatric patients ages 0-3 years Easy Intubation (Cormach-Lehane score I-II) |
| Group II Difficult intubation | – | Other: Easy IntubationPediatric patients ages 0-3 years Difficult intubation (Cormach-Lehane score III-IV) |
Who may qualify
- Ages
- 1 month to 36 months
- Sex
- All
- Age groups
- Child
- Study population
- Demographic data, head circumference, weight, height measurements, body mass index and percentile values were recorded by a pediatric surgeon who was unaware about the studyin the preoperative period.
Key inclusion criteria (2 listed)
- 0-3 years old (1-36 mounts) pediatric patients
- Patients 0-3 age years old with ASA I, undergoing elective surgery were included in this study
Key exclusion criteria (1 listed)
- Patients with known syndrome, facial anomaly, ASA score above 2 and laryngeal mask aiway were excluded from the study
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 |
|---|---|---|
| Easy IntubationAlso: Difficult intubation | Other | Group I Easy Intubation, Group II Difficult intubation |
Primary outcome
Difficult laryngoscopy classification using Cormack-LehaneGrade Assessment of difficult laryngoscopy at the time of the airway management procedure.
Time frame: immediate
Classified as Grade I-visualization of entire laryngeal aperture, grade II-visualization of only posterior commissure of laryngeal aperture, grade III-visualization of only epiglottis, grade IV-visualization of just the soft palate.
5 secondary outcomes
Head circumference measured in cm with a measuring tape.
Time frame: immediate
Weight measured in kilogram with electronic scale.
Time frame: immediate
Height measured in cm with infantometer.
Time frame: immediate
BMI was calculated as kg/m2.
Time frame: immediate
Percentage values measured in % with percentile tables.
Time frame: immediate
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 21 Aug 2018.
- Results publication: PubMed 22340664Heinrich S, Birkholz T, Ihmsen H, Irouschek A, Ackermann A, Schmidt J. Incidence and predictors of difficult laryngoscopy in 11,219 pediatric anesthesia procedures. Paediatr Anaesth. 2012 Aug;22(8):729-36. doi: 10.1111/j.1460-9592.2012.03813.x. Epub 2012 Feb 20.
- Results publication: PubMed 23083795Heinrich S, Birkholz T, Ihmsen H, Irouschek A, Ackermann A, Cesnjevar R, Schmidt J. Incidence and predictors of poor laryngoscopic view in children undergoing pediatric cardiac surgery. J Cardiothorac Vasc Anesth. 2013 Jun;27(3):516-21. doi: 10.1053/j.jvca.2012.08.019. Epub 2012 Oct 17.
- Results publication: PubMed 25437694Inal MT, Memis D, Sahin SH, Gunday I. [Comparison of different tests to determine difficult intubation in pediatric patients]. Rev Bras Anestesiol. 2014 Nov-Dec;64(6):391-4. doi: 10.1016/j.bjan.2014.02.001. Epub 2014 Aug 28. Portuguese.
- Results publication: PubMed 26968055Mansano AM, Modolo NS, Silva LM, Ganem EM, Braz LG, Knabe Ade C, Freitas FM. Bedside tests to predict laryngoscopic difficulty in pediatric patients. Int J Pediatr Otorhinolaryngol. 2016 Apr;83:63-8. doi: 10.1016/j.ijporl.2016.01.031. Epub 2016 Feb 3.
- Results publication: 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.
- Individual participant dataSharing planned: No. Value of BMI and Anthropometric Measurements with CL Test in Predicting Difficult Laryngoscopy in Children
Related trials for Difficult Intubation
Not yet recruitingObservational study
A Novel Score for Procedural Difficulty During Videolaryngoscopic Intubation
Intubation, Intratracheal, Airway Management
RecruitingObservational study
Comparison of Two Sedation Regimens for Awake Fiberoptic Intubation
Awake Fiberoptic Intubation, Difficult Airway
Not yet recruitingObservational study
Modified El-Ganzouri Risk Index for Predicting Difficult Intubation in Obese Patients
Difficult Intubation, Obesity
Enrolling by invitationObservational study
Difficult Airway Management in Oncology: An International Delphi Consensus Study (DAMO)
Neoplasms, Airway Obstruction Upper
Not yet recruitingObservational study
Correlation Between Bedside Anatomical Indicators and Lifting Force and Glottic Exposure Under Different Video Laryngoscopy Techniques
Difficult Airway, Intubation, Intratracheal
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.
PERVIN BOZKURT, Prof study director
Tepecik Education 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 Difficult Intubation and Pediatrics, run by Tepecik 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 1 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 21 Aug 2018. 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?
Difficult laryngoscopy classification using Cormack-LehaneGrade Assessment of difficult laryngoscopy at the time of the airway management procedure. (time frame: immediate). 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 NCT03641157, which also lists 5 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 21 Aug 2018.