Prognostic Factors for Difficult Intubation

The Predictors of Difficult Intubation in Pediatric Patients Clinical Trial

Official title:

Prognostic Factors for Difficult Intubation in Pediatric Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04043767
• Other study ID #: difficult airway
• Status: Recruiting
• Start date: May 1, 2018
• Est. completion date: February 2021

Study information

• Verified date: July 2019
• Source: Prince of Songkla University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Difficult intubation is the situation that anesthesiologists don't want to face. Sometimes, difficult intubation affects the patient's oxygen saturation and harms for life. Many studies try to identify the predictors of difficult airway in pediatric patients. In this study, the investigator team want to identify the predictors of difficult intubation in pediatric patient by using additional parameters which are including hyomental distance, sternomental distance, neck circumference, ratio of hyomental distance to Thyromental distance, ratio of hyomental distance to sternomental distance, ratio of height to neck circumference, ratio of height to thyromental distance, Ratio of height to hyomental distance.

Description:

After approval from the instution's Ethics Committee, a prospective cohort study was conducted in pediatric patients aged between 1-8 years, ASA physical status I-II who were scheduled for general anesthesia in elective surgery. One day prior surgery, Children and their parents were invited to be participated in the study by using verbal invitation and flyer. After giving consent, Addition physical examinations which are the measurements of hyomental distance, sternomental distance and neck circumference were done by two independent investigators. The ratio of hyomental distance to Thyromental distance, ratio of hyomental distance to sternomental distance, ratio of height to neck circumference, ratio of height to thyromental distance and ratio of height to hyomental distance. At the day of surgery, standard general anesthesia (balance technique) was done. The child was intubated using aged appropriated laryngoscope by general anesthesiologist. Cormack-Lehane grading was used to identify the difficult intubation. (grade III and IV). Data will be analyzed by R Program. The statistically significance was set as P<0.05. Multivariate Logistic Regression analysis will be used to identify the predictors of difficult intubation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 660
• Est. completion date: February 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 8 Years

Eligibility

Inclusion Criteria:

• Pediatric patients aged between 1-8 years

• Schedule for elective surgery

• Having balance Anesthesia technique for surgery

Exclusion Criteria:

• Having aspiration risks

• Having history of difficult airway

• Abnormality of cervical spine /head and neck area

• Parental refusion

Related Conditions & MeSH terms

• The Predictors of Difficult Intubation in Pediatric Patients

Intervention

Procedure:
• Measurements of thyromental distances, hyomental distances and neck circumferences
thyromental distances, hyomental distances and neck circumferences using measurement tape by two independent investigators.

Locations

Country	Name	City	State
Thailand	Ngamjit Pattaravit	Songkhla

Sponsors (1)

Lead Sponsor	Collaborator
Prince of Songkla University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The predictors of difficult airway	Laryngoscopic view was determined by using Cormack-Lehane grading (grade III-IV) were used to identify difficult intubation situation	up to 1 minutes after starting the process of intubation
Secondary	The correlation between time spent for intubation and laryngoscopic view	Laryngoscopic view was determined by using Cormack-Lehane grading (grade III-IV) were used to identify difficult intubation situation	up to 10 minutes after starting the process of intubation