Paediatric Airway ManagementNCT05885789
Improvement of Laryngoscopic View by Bed-up-head-elevated Position During Tracheal Intubation in Paediatric Patients
An observational study of Paediatric Airway Management, run by University of Malaya at 1 site in Malaysia.
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. Read more about this study
- Who is it for?
- Ages 3 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Paediatric Airway Management
- What is being tested?
- Intubation in Bed-Up-Head-Elevated (BUHE) position
- Type of treatment
- Surgery or procedure
- How many people
- 125 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Mar 2023to 31 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Paediatric patients age 3-12 year-old undergoing elective surgery under general anaesthesia requiring tracheal intubation
Who may be able to join
- Age 3 to 12 years
- Elective surgery under general anaesthesia requiring tracheal intubation
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Malaysia1 site, 1 recruiting
- Recruiting
University of Malaya Medical Center
Kuala Lumpur, 59100
Bao Zhen Dr. Kim, +603-79494422
About this study
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:
- 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.
Read the 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.
- Conditions
- Paediatric Airway Management
- Being tested
- Intubation in Bed-Up-Head-Elevated (BUHE) position
- Keywords
- Paediatric, Intubation, Laryngoscopy, Head position, BUHE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intubation in Bed-Up-Head-Elevated (BUHE) positionProcedure or surgery
Comparing laryngoscopic view in paediatric patients during sniffing position and BUHE position
| Study group | Role | What they receive |
|---|---|---|
| Paediatric patients | Not described Receives: Procedure: Intubation in Bed-Up-Head-Elevated (BUHE) position |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediate during procedure
Secondary outcomes (1)
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
Measured: Immediate during procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2023
- Study start1 Mar 2023
- Primary completion31 May 2024 (estimated)
- Study completion31 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Paediatric Airway ManagementStudies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kim Bao Zhen, University of Malaya
- Investigators
- Bao Zhen Dr. Kim, MD, Principal investigator, University of Malaya Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05885789
- Sponsor's protocol ID
- BUHE in paediatric
- Status last verified
- Jun 2023
- First submitted
- 22 May 2023
- Last updated
- 5 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Study Protocol Statistical Analysis Plan (SAP) Clinical Study Report (CSR)
Publications
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.
PubMed 26243378Schmidt 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.
PubMed 24247412Holm-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.
PubMed 19128325Vialet 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.
PubMed 19434789Kim 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.
PubMed 28139308Ahn 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.
PubMed 30718623Lee 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.
PubMed 17611252Black 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.
PubMed 25684039Tsan 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.
PubMed 31348051
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement of Laryngoscopic View by Bed-up-head-elevated Position During Tracheal Intubation in Paediatric Patients
- ClinicalTrials.gov ID
- NCT05885789
- Acronym / sponsor ID
- BUHE in paediatric
- Conditions
- Paediatric Airway Management
- Keywords
- Paediatric, Intubation, Laryngoscopy, Head position, BUHE
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 31 May 2024 (estimated)
- First posted
- 2 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
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
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Paediatric patients | – | Procedure: Intubation in Bed-Up-Head-Elevated (BUHE) position |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Paediatric patients age 3-12 year-old undergoing elective surgery under general anaesthesia requiring tracheal intubation
Key inclusion criteria (2 listed)
- Age 3 to 12 years
- Elective surgery under general anaesthesia requiring tracheal intubation
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intubation in Bed-Up-Head-Elevated (BUHE) positionComparing laryngoscopic view in paediatric patients during sniffing position and BUHE position | Procedure or surgery | Paediatric patients |
Primary outcome
Change in Percentage of Glottic Opening (POGO) score after BUHE position
Time frame: 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.
1 secondary outcome
Ease of handling of laryngoscope
Time frame: Immediate during procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2023.
- Background: PubMed 26243378Karsli 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.
- Background: PubMed 24247412Schmidt 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.
- Background: PubMed 19128325Holm-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.
- Background: PubMed 19434789Vialet 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.
- Background: PubMed 28139308Kim 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.
- Background: PubMed 30718623Ahn 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.
- Background: PubMed 17611252Lee 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.
- Background: PubMed 25684039Black 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.
- Results publication: PubMed 31348051Tsan 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.
- Individual participant dataSharing planned: Undecided. Study Protocol Statistical Analysis Plan (SAP) Clinical Study Report (CSR)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bao Zhen Dr. Kim, MD principal investigator
University of Malaya Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Paediatric Airway Management, run by University of Malaya at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bao Zhen Dr. Kim, MD (+6016-7978582, zhenkim1990@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Percentage of Glottic Opening (POGO) score after BUHE position (time frame: Immediate during procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05885789, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2023.