Improvement of Laryngoscopic View by Bed-up-head-elevated Position During Tracheal Intubation in Paediatric Patients

Paediatric Airway Management Clinical Trial

Official title:

Improvement of Laryngoscopic View by Bed-up-head-elevated Position During Tracheal Intubation in Paediatric Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05885789
• Other study ID #: BUHE in paediatric
• Status: Recruiting
• Start date: March 1, 2023
• Est. completion date: May 31, 2024

Study information

• Verified date: June 2023
• Source: University of Malaya
• Contact: Bao Zhen Dr. Kim, MD
• Phone: +6016-7978582
• Email: zhenkim1990[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The goal of this prospective observational study is to learn about improvement of laryngoscopic view by Bed-Up-Head-Elevated (BUHE) during tracheal intubation in paediatric patients. The main question it aims to answer is:

1. Does BUHE position improve laryngoscopic view during paediatric intubation?

Participants age 3-12 year-old going for elective surgery under general anaesthesia requiring tracheal intubation will undergo laryngoscopic twice, first in sniffing position (SP) and second during BUHE position.

POGO score during each laryngoscope will be compared. Additionally, ease of handling of laryngoscope during each position will be assessed.

Description:

This is a prospective observational study comparing POGO score during tracheal intubation in SP and BUHE position in paediatric patients aged 3 to 12 years who will undergo elective surgery under general anaesthesia requiring tracheal intubation. The first POGO score will be obtained during SP followed by second POGO score during BUHE position and the difference in POGO score before and after BUHE position will be recorded to learn the improvement in POGO score during BUHE position.

The objective of this study is to learn the improvement of laryngeal view in tracheal intubation after BUHE position in paediatric patients of age 3 to 12 years. Investigators hypothesised that laryngeal view in tracheal intubation improves after BUHE position compared to sniffing position.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 125
• Est. completion date: May 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 12 Years

Eligibility

Inclusion Criteria:

• Age 3 to 12 years

• Elective surgery under general anaesthesia requiring tracheal intubation

Exclusion Criteria:

• Parents' / Guardian's refusal

• Known case of difficult airway or airway malformation or airway obstruction

• Patients with respiratory or cardiovascular disease

• Patients requiring rapid sequence induction

• Recent Upper Respiratory Tract Infection (URTI) of 2 weeks

Related Conditions & MeSH terms

• Paediatric Airway Management

Intervention

Procedure:
• Intubation in Bed-Up-Head-Elevated (BUHE) position
Comparing laryngoscopic view in paediatric patients during sniffing position and BUHE position

Locations

Country	Name	City	State
Malaysia	University of Malaya Medical Center	Kuala Lumpur

Sponsors (1)

Lead Sponsor	Collaborator
University of Malaya

Country where clinical trial is conducted

Malaysia, 

References & Publications (9)

Ahn JH, Kim D, Gil NS, Son YH, Seong BG, Jeong JS. Improvement of laryngoscopic view by hand-assisted elevation and caudad traction of the shoulder during tracheal intubation in pediatric patients. Sci Rep. 2019 Feb 4;9(1):1174. doi: 10.1038/s41598-018-37770-6. — View Citation

Black AE, Flynn PE, Smith HL, Thomas ML, Wilkinson KA; Association of Pediatric Anaesthetists of Great Britain and Ireland. Development of a guideline for the management of the unanticipated difficult airway in pediatric practice. Paediatr Anaesth. 2015 Apr;25(4):346-62. doi: 10.1111/pan.12615. Epub 2015 Feb 16. — View Citation

Holm-Knudsen RJ, Rasmussen LS. Paediatric airway management: basic aspects. Acta Anaesthesiol Scand. 2009 Jan;53(1):1-9. doi: 10.1111/j.1399-6576.2008.01794.x. Erratum In: Acta Anaesthesiol Scand. 2009 Apr;53(4):552. — View Citation

Karsli C. Managing the challenging pediatric airway: Continuing Professional Development. Can J Anaesth. 2015 Sep;62(9):1000-16. doi: 10.1007/s12630-015-0423-y. Epub 2015 Aug 5. Erratum In: Can J Anaesth. 2015 Dec;62(12):1364. — View Citation

Kim EH, Ji SH, Song IK, Lee JH, Kim JT, Kim HS. Simple method for obtaining the optimal laryngoscopic view in children: A prospective observational study. Am J Emerg Med. 2017 Jun;35(6):867-870. doi: 10.1016/j.ajem.2017.01.048. Epub 2017 Jan 24. — View Citation

Lee BJ, Kang JM, Kim DO. Laryngeal exposure during laryngoscopy is better in the 25 degrees back-up position than in the supine position. Br J Anaesth. 2007 Oct;99(4):581-6. doi: 10.1093/bja/aem095. Epub 2007 Jul 4. — View Citation

Schmidt AR, Weiss M, Engelhardt T. The paediatric airway: basic principles and current developments. Eur J Anaesthesiol. 2014 Jun;31(6):293-9. doi: 10.1097/EJA.0000000000000023. — View Citation

Tsan SEH, Lim SM, Abidin MFZ, Ganesh S, Wang CY. Comparison of Macintosh Laryngoscopy in Bed-up-Head-Elevated Position With GlideScope Laryngoscopy: A Randomized, Controlled, Noninferiority Trial. Anesth Analg. 2020 Jul;131(1):210-219. doi: 10.1213/ANE.00 — View Citation

Vialet R, Nau A. Effect of head posture on pediatric oropharyngeal structures: implications for airway management in infants and children. Curr Opin Anaesthesiol. 2009 Jun;22(3):396-9. doi: 10.1097/aco.0b013e3283294cc7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Percentage of Glottic Opening (POGO) score after BUHE position	Compare change in Percentage of Glottic Opening (POGO) score in sniffing position (SP) and after BUHE position. The POGO score is expressed as a percentage of glottis exposure in the laryngoscopy view, which is expressed as 100% for a fully exposed glottis, from the anterior commissure of the vocal cords to the inter-arytenoid notch. POGO score of 0% corresponds to no visualisation of laryngeal structure.	Immediate during procedure
Secondary	Ease of handling of laryngoscope	assessed based on a scale of 0 to 10, 0 being the most difficult and uncomfortable handling and 10 being the easiest and most comfortable handling	Immediate during procedure