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Comparison Between the Subglotic Diameter and the Epiphyseal Diameter of the Radius in Children for Prediction of Appropriate Endotracheal Tube Sizes

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ClinicalTrials.gov Identifier: NCT03713385
Recruitment Status : Recruiting
First Posted : October 19, 2018
Last Update Posted : March 7, 2019
Sponsor:
Information provided by (Responsible Party):
Nevert Adel, Mansoura University

Brief Summary:

Background: In pediatric anesthesia, selection of the appropriate endotracheal tube (ETT) size is an important task because the inappropriate one may lead to much complication. The aim of this study is to compare between the subglotic diameter and the epiphysis diameter of radius measured by ultrasonography for prediction of optimum endotracheal tube size in children.

Methods: Patients aged from 1 to 6 years will be scheduled for elective surgery under general anesthesia and intubation, were enrolled in this study. Patients were randomly divided into three groups according to method of choosing the tube size.

Aged group (n =49): determined the optimal endotracheal tube size according to age of the child (internal diameter [ID] in mm = [age in years + 16] /4) suggested by Cole.4 Subglottic diameter group (n =49): The subglottic transverse diameter was estimated with ultrasonography on the middle of the anterior region of the neck at the level of cricoid cartilage.

Epiphyseal diameter group (n =49): the epiphyseal transverse diameter of the distal radius was estimated with ultrasonography.

Patient descriptive data, size of the selected ETT, number and size of the optimum tube, number of re-intubation due to incorrect size of ETT either smaller or larger were recorded. Subglottic transverse diameter (mm) and time of intubation were measured. After intubation, pulse, respiratory rate, arterial blood saturation, capnograghy and airway pressure were recorded during surgery.

Any airway complications after extubation as edema, stenosis or stridor were also recorded.


Condition or disease
Prediction of Pediatric Endotracheal Tube Size

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 147 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Comparison Between the Subglotic Diameter and the Epiphyseal Diameter of the Radius in Children for Prediction of Appropriate Endotracheal Tube Sizes
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : July 1, 2019
Estimated Study Completion Date : August 1, 2019

Group/Cohort
Aged group (n =49)
Determined the optimal endotracheal tube size according to age of the child (internal diameter [ID] in mm = [age in years + 16] /4) suggested by Cole
Subglottic diameter group (n =49)
The subglottic transverse diameter was estimated with ultrasonography on the middle of the anterior region of the neck at the level of cricoid cartilage
Epiphyseal diameter group (n =49)
The epiphyseal transverse diameter of the distal radius was estimated with ultrasonography.



Primary Outcome Measures :
  1. number of the optimum tube size [ Time Frame: 3 months ]
    number of the optimum tube size used in pediatric patients in each group


Secondary Outcome Measures :
  1. number of re-intubation [ Time Frame: 3 months ]
    number of re-intubation due to incorrect size of ETT either smaller or larger in each group


Other Outcome Measures:
  1. time of intubation [ Time Frame: 3 months ]
    time was taken for intubation in each group

  2. airway complications [ Time Frame: 3 months ]
    airway complications after extubation as edema, stenosis or stridor



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Ages Eligible for Study:   1 Year to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients aged from 1 to 6 years will be scheduled for elective surgery under general anesthesia and intubation in Pediatric Hospital Mansoura University.
Criteria

Inclusion Criteria:

  • Patients aged from 1 to 6 years
  • scheduled for elective surgery under general anesthesia and intubation

Exclusion Criteria:

  • Patients refusal
  • An anticipated difficult airway,
  • Any respiratory disease that might cause airway narrowing
  • Pre-exiting laryngeal or tracheal pathology
  • Any lesion that could cause airway deformity due to fibrosis or the presence of a neck anatomical pathologies that could affect the ultrasound evaluation of the airway
  • Any abnormality in the wrist and radius bone
  • Any disease after epiphyseal diameter as Rickets or skeletal dysplasia
  • Prolonged surgery more than 90 minutes

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): NCT03713385


Contacts
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Contact: Nevert Adel Abdel ghaffar 01223947977 neverta@yahoo.com

Locations
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Egypt
Gamal Zakaria Recruiting
Mansourah, Egypt
Contact: Yahya Mohamed Wahba, Ass prof    01211313554    yahyawahba@ymail.com   
Sub-Investigator: Yahya Mohamed Wahba, MD         
Sub-Investigator: Abdel-Hady El-Gilany, MD         
Sub-Investigator: Gamal Zakaria, MD         
Sponsors and Collaborators
Mansoura University

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Responsible Party: Nevert Adel, lecturer of anesthesia, surgical ICU and pain management, Mansoura University
ClinicalTrials.gov Identifier: NCT03713385     History of Changes
Other Study ID Numbers: MansouraU4
First Posted: October 19, 2018    Key Record Dates
Last Update Posted: March 7, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No