NCT05885789

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
125

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 22, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 2, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2024

Completed
Last Updated

June 5, 2023

Status Verified

June 1, 2023

Enrollment Period

1.3 years

First QC Date

May 22, 2023

Last Update Submit

June 1, 2023

Conditions

Keywords

PaediatricIntubationLaryngoscopyHead positionBUHE

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Ease of handling of laryngoscope

    Immediate during procedure

Study Arms (1)

Paediatric patients

Procedure: Intubation in Bed-Up-Head-Elevated (BUHE) position

Interventions

Comparing laryngoscopic view in paediatric patients during sniffing position and BUHE position

Paediatric patients

Eligibility Criteria

Age3 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Paediatric patients age 3-12 year-old undergoing elective surgery under general anaesthesia requiring tracheal intubation

You may qualify if:

  • Age 3 to 12 years
  • Elective surgery under general anaesthesia requiring tracheal intubation

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Malaya Medical Center

Kuala Lumpur, 59100, Malaysia

RECRUITING

Related Publications (9)

  • 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.

    PMID: 26243378BACKGROUND
  • 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.

    PMID: 24247412BACKGROUND
  • 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.

    PMID: 19128325BACKGROUND
  • 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.

    PMID: 19434789BACKGROUND
  • 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.

    PMID: 28139308BACKGROUND
  • 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.

    PMID: 30718623BACKGROUND
  • 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.

    PMID: 17611252BACKGROUND
  • 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.

    PMID: 25684039BACKGROUND
  • 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.0000000000004349.

MeSH Terms

Interventions

IntubationPatient Positioning

Intervention Hierarchy (Ancestors)

TherapeuticsInvestigative TechniquesPatient CareHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Bao Zhen Dr. Kim, MD

    University of Malaya Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bao Zhen Dr. Kim, MD

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

May 22, 2023

First Posted

June 2, 2023

Study Start

March 1, 2023

Primary Completion

May 31, 2024

Study Completion

May 31, 2024

Last Updated

June 5, 2023

Record last verified: 2023-06

Locations