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

Sponsor
University of Malaya (Other)
Overall Status
Recruiting
CT.gov ID
NCT05885789
Collaborator
(none)
125
1
15
8.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Intubation in Bed-Up-Head-Elevated (BUHE) position

Detailed 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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
125 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Improvement of Laryngoscopic View by Bed-up-head-elevated Position During Tracheal Intubation in Paediatric Patients
Actual Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
May 31, 2024
Anticipated Study Completion Date :
May 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Paediatric patients

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

Outcome Measures

Primary Outcome Measures

  1. Change in Percentage of Glottic Opening (POGO) score after BUHE position [Immediate during procedure]

    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.

Secondary Outcome Measures

  1. Ease of handling of laryngoscope [Immediate during procedure]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
3 Years to 12 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Malaya Medical Center Kuala Lumpur Malaysia 59100

Sponsors and Collaborators

  • University of Malaya

Investigators

  • Principal Investigator: Bao Zhen Dr. Kim, MD, University of Malaya Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Kim Bao Zhen, Principal investigator, University of Malaya
ClinicalTrials.gov Identifier:
NCT05885789
Other Study ID Numbers:
  • BUHE in paediatric
First Posted:
Jun 2, 2023
Last Update Posted:
Jun 5, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Kim Bao Zhen, Principal investigator, University of Malaya

Study Results

No Results Posted as of Jun 5, 2023