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Predicting Difficult Airway in Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03641157
Recruitment Status : Completed
First Posted : August 21, 2018
Last Update Posted : August 21, 2018
Sponsor:
Information provided by (Responsible Party):
GAYE AYDIN, Tepecik Training and Research Hospital

Brief 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.

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.


Condition or disease Intervention/treatment
Difficult Intubation Pediatrics Other: Easy Intubation

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Study Type : Observational
Actual Enrollment : 108 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Value of BMI and Anthropometric Measurements With CL Test in Predicting Difficult Laryngoscopy in Children
Actual Study Start Date : July 11, 2014
Actual Primary Completion Date : July 11, 2016
Actual Study Completion Date : July 11, 2016

Group/Cohort Intervention/treatment
Group I Easy Intubation
Pediatric patients ages 0-3 years Easy Intubation (Cormach-Lehane score I-II)
Other: Easy Intubation
Other Name: Difficult intubation

Group II Difficult intubation
Pediatric patients ages 0-3 years Difficult intubation (Cormach-Lehane score III-IV)
Other: Easy Intubation
Other Name: Difficult intubation




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Head circumference measured in cm with a measuring tape. [ Time Frame: immediate ]
    Head circumference were taken at the level above eyebrows and ears and measured in cm with a measuring tape.

  2. Weight measured in kilogram with electronic scale. [ Time Frame: immediate ]
    Weight measured using electronic scale (0-20 kg) while undressed and without diapers .

  3. Height measured in cm with infantometer. [ Time Frame: immediate ]
    Height measured using a portable infantometer (0-100 cm) while the child was in supine position.

  4. BMI was calculated as kg/m2. [ Time Frame: immediate ]
    BMI measured using a weight/height2 formul

  5. Percentage values measured in % with percentile tables. [ Time Frame: immediate ]
    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.



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Ages Eligible for Study:   1 Month to 36 Months   (Child)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   pediatric patients
Sampling Method:   Probability Sample
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.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Patients with known syndrome, facial anomaly, ASA score above 2 and laryngeal mask aiway were excluded from the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03641157


Locations
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Turkey
Tepecik Education and Research Hospital
Izmir, Turkey
Sponsors and Collaborators
Tepecik Training and Research Hospital
Investigators
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Study Director: PERVIN BOZKURT, Prof Tepecik Education and Research Hospital
Publications of Results:
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Responsible Party: GAYE AYDIN, Anesthesiology and Reanimation Clinic, principal investigator, Clinical Associated Professor, Tepecik Training and Research Hospital
ClinicalTrials.gov Identifier: NCT03641157    
Other Study ID Numbers: GAYDIN
First Posted: August 21, 2018    Key Record Dates
Last Update Posted: August 21, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Value of BMI and Anthropometric Measurements with CL Test in Predicting Difficult Laryngoscopy in Children

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by GAYE AYDIN, Tepecik Training and Research Hospital:
Difficult intubation
Pediatrics
predictive tests