Prognostic Factors for Difficult Intubation

Prognostic Factors for Difficult Intubation in Pediatric Patients

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.

Study Overview

• Status: Unknown
• Conditions: The Predictors of Difficult Intubation in Pediatric Patients
• Intervention / Treatment: Procedure: Measurements of thyromental distances, hyomental distances and neck circumferences

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.

• Study Type: Observational
• Enrollment (Anticipated): 660

Contacts and Locations

Study Locations

• Thailand
  • Songkhla, Thailand, 90110
    • Recruiting
    • Ngamjit Pattaravit
    • Contact: Ngamjit Pattaravit, M.D.; Phone Number: 66897001350; Email: ngamjitp@yahoo.com
    • Contact: Maneemontra sunanand, M.D.; Phone Number: 66849194975; Email: hich_ice@hotmail.com
    • Principal Investigator: Ngamjit Pattaravit, M.D.
    • Sub-Investigator: Maneemontra Sunanand, M.D.
    • Sub-Investigator: Sumidra Prathep, M.D.
    • Sub-Investigator: Chanatthee Kitsiripant, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 8 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pediatric patients aged between 1-8 years; Pediatric patients aged between 1-8 years who scheduled for general anesthesia in elective surgery. Additional physical examinations which were including thyromental distances, hyomental distances and neck circumferences, was performed at one day prior surgery. Intubation was done by general anesthesiologist in order to grade the laryngoscopic view.	Procedure: Measurements of thyromental distances, hyomental distances and neck circumferences; thyromental distances, hyomental distances and neck circumferences using measurement tape by two independent investigators.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Prince of Songkla University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2018
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): February 1, 2021

Study Registration Dates

• First Submitted: July 30, 2019
• First Submitted That Met QC Criteria: July 31, 2019
• First Posted (Actual): August 2, 2019

Study Record Updates

• Last Update Posted (Actual): August 2, 2019
• Last Update Submitted That Met QC Criteria: July 31, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: predictors, difficult intubation, pediatric patient
• Other Study ID Numbers: difficult airway

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No