Ultrasonography for Prediction of Difficult Intubation and Prediction of Endotracheal Tube Size

Intubation; Difficult or Failed Clinical Trial

Official title:

Ultrasonographic Thyrohyoid Distance Measurement for Prediction of Difficult Intubation and Ultrasonographic Prediction of Pediatric Endotracheal Tube Size

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03013036
• Other study ID #: 0964
• Status: Recruiting
• Phase: N/A
• First received: December 27, 2016
• Last updated: January 5, 2017
• Start date: February 2013

Study information

• Verified date: January 2017
• Source: Istanbul University
• Contact: Elif A Ozmumcu, M.D.
• Phone: 00905332934202
• Email: elfaybike[@]yahoo.com
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Aim of our study is to evaluate the predictive value of ultrasonographic (USG) measurement of thyrohyoid distance for difficult intubation and determination of optimal endotracheal tube size by using USG in pediatric patients undergoing elective surgery.

Description:

After ethics committee approval and parental consent were obtained, 119 patients undergoing genitourinary surgery or inguinal hernia repair under general anesthesia, were included in study. Patients with head or neck anomalies, syndromic patients, patients undergoing emergency surgery and patients with a history of difficult airway were excluded from the study. Patients were grouped according to their ages; Group I (1-2 years,n=38), Group II (3-5 years,n=46) and Group III (6-8 years,n=35). USG measurements were performed following sevoflurane induction in groups I and II. In group III, USG measurements were performed following premedication with intravenous midazolam 0.05 mg/kg . Thyrohyoid distance, glottic and subglottic diameters were measured with ultrasonography. The size of the endotracheal tube according to Bae's formula ( internal diameter of Endotracheal tube = 0.705 x subglottic diameter - 0.091) was calculated and recorded. Before intubation, endotracheal tube (cuffed/uncuffed) was selected using age-related formulas. In group II, anaesthesia induction was achieved with propofol 2 mg/kg. In all groups, endotracheal intubation was achieved with fentanyl 2μg/kg and rocuronium 0.6 mg/kg. Endotracheal tube size was considered as optimal when a leak was detected at 20-30cmH₂O inflation pressures. If a resistance was felt in the subglottic region, the tube was exchanged with a smaller and was exchanged with a larger (0.5 mm) size if a leak occurred at inflation pressures lower than 20cmH₂O. Intubation duration , Cormack-Lehane scores and Intubation Difficulty Scale scores were recorded. For comparison of age related formula and Bae 's formula, only patients who were intubated with un-cuffed endotracheal tube were evaluated.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 8 Years

Eligibility

Inclusion Criteria:

• Aged between 1 and 8 years

• Elective surgery

Exclusion Criteria:

• Patients with head or neck abnormalities

• Syndromic patients

• Emergency surgery and patients with a

• History of difficult airway

• Allergy to ultrasound gel

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Intubation; Difficult or Failed

Intervention

Device:
• Ultrasonography

Drug:
• Sevoflurane

• intravenous midazolam

• Propofol

• fentanyl and rocuronium

Locations

Country	Name	City	State
Turkey	Istanbul University Cerrahpasa Medical Faculty	Istanbul	Fatih

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evidence of difficult intubation (determined with Intubation Difficulty Scale) in patients who have short thyrohyoid distance		three years	No
Primary	Consistency of endotracheal tube sizes selected with aged related formulas and with ultrasonographic measurement of subglotic diameter		three years	No