New Formula for Selection of Proper Size of Endotracheal Tube (ETT) in Children: Ultrasonographic Examination
| Tracking Information | |
|---|---|
| First Received Date ICMJE | October 22, 2010 |
| Last Updated Date | May 12, 2011 |
| Start Date ICMJE | February 2010 |
| Primary Completion Date | December 2010 (final data collection date for primary outcome measure) |
| Current Primary Outcome Measures ICMJE | Not Provided |
| Original Primary Outcome Measures ICMJE | Not Provided |
| Change History | Complete list of historical versions of study NCT01227161 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | Not Provided |
| Original Secondary Outcome Measures ICMJE | Not Provided |
| Current Other Outcome Measures ICMJE | Not Provided |
| Original Other Outcome Measures ICMJE | Not Provided |
| Descriptive Information | |
| Brief Title ICMJE | New Formula for Selection of Proper Size of Endotracheal Tube (ETT) in Children: Ultrasonographic Examination |
| Official Title ICMJE | New Formula for Selection of Proper Size of ETT in Children: Ultrasonographic Examination |
| Brief Summary | Choosing the adequate size of endotracheal tube(ETT) in pediatric patients is important in all anesthesiologists, pediatricians, and critical care specialists. Inadequate ETT size will results in soft tissue injury to trachea by means of the pressure, insufficient ventilation, and aspiration, therefore choosing the adequate ETT size has very important clinical aspect. |
| Detailed Description | Choosing the adequate size of endotracheal tube(ETT) in pediatric patients is important in all anesthesiologists, pediatricians, and critical care specialists. Inadequate ETT size will results in soft tissue injury to trachea by means of the pressure, insufficient ventilation, and aspiration, therefore choosing the adequate ETT size has very important clinical aspect. Subglottis is the narrowest portion of upper airway. Thus, ETT size should be determined according to the subglottic diameter. Several conventional methods are available to determine ETT size. These methods are based on the demographic data of patient, such as age, weight, height, but could not be customized for each patient. Ultrasonography (US) is one of the most accurate method to measure the subglottic diameter. Also, US is quick, easy to perform, and non-invasive measure. The investigators tried to measure the exact subglottic diameter with US and analyze the correlation of the diameter and demographical data. Furthermore, the investigators will try to develop the equation that could determine the adequate ETT size based on demographical data, instead of actually measuring the subglottic diameter using US. |
| Study Type ICMJE | Observational |
| Study Design ICMJE | Observational Model: Case-Only |
| Target Follow-Up Duration | Not Provided |
| Biospecimen | Not Provided |
| Sampling Method | Probability Sample |
| Study Population | University Hospital (Severance Hospital, Seoul, S.Korea) |
| Condition ICMJE | Elective Urological Surgery |
| Intervention ICMJE | Not Provided |
| Study Group/Cohort (s) | ultrasonography children
American Society of Anesthesiologists (ASA) I-II children between the age 0-7, undergoing elective urological surgery, such as inguinal hernia repair, orchiopexy, ureteroneocystostomy |
| Publications * | Not Provided |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | 215 |
| Completion Date | February 2011 |
| Primary Completion Date | December 2010 (final data collection date for primary outcome measure) |
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both |
| Ages | up to 7 Years |
| Accepts Healthy Volunteers | Yes |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | Korea, Republic of |
| Administrative Information | |
| NCT Number ICMJE | NCT01227161 |
| Other Study ID Numbers ICMJE | 4-2009-0723 |
| Has Data Monitoring Committee | No |
| Responsible Party | Hae-Keum Kim / Professor, Department of Anesthesiology and Pain Medicine, Severance Hospital |
| Study Sponsor ICMJE | Yonsei University |
| Collaborators ICMJE | Not Provided |
| Investigators ICMJE | Not Provided |
| Information Provided By | Yonsei University |
| Verification Date | May 2011 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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