Clinical trial NCT04043767: Prognostic Factors for Difficult Intubation
Official title: Prognostic Factors for Difficult Intubation in Pediatric Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: The Predictors of Difficult Intubation in Pediatric Patients
Keywords: predictors, difficult intubation, pediatric patient
Lead sponsor: Prince of Songkla University
Sponsor class: OTHER
First posted: 2019-08-02
Enrollment: 660
Sex: ALL
Minimum age (years): 1
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric patients aged between 1-8 years who schedule for elective surgery and having balance Anesthesia technique for surgery

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: The predictors of difficult airway
timeFrame: up to 1 minutes after starting the process of intubation
Secondary outcomes:
measure: The correlation between time spent for intubation and laryngoscopic view
timeFrame: up to 10 minutes after starting the process of intubation
Other outcomes:
Locations:
city: Songkhla
country: Thailand
facility: Ngamjit Pattaravit
Study officials:
References: