Intubation;DifficultPentaxNCT03118622
Pentax Videolaryngoscopy in Children
An observational study of Intubation;Difficult, run by Ajou University School of Medicine at 1 site in South Korea.
Trial summary
Comparison of Intubation using Pentax (Pentas AWS, Pentax, Tokyo, Japan) and Macintoch in pediatric patients Read more about this study
- Who is it for?
- Ages 1 year to 10 years
- Conditions the study is for
- Intubation;Difficult
- What is being tested?
- Pentax
- Type of treatment
- Medical device
- How many people
- 136 participants
- Where
- 1 siteSouth Korea
- Study dates
- 31 May 2017to 8 Jan 2018
- 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 1 year to 10 years
- All sexes
- No healthy volunteers
- Child
Study population: Pediatric patients
Who may be able to join
- ASA 1, 2
- Scheduled surgery under general anesthesia
Who cannot join
- Intraoral disease
- Congenital anomaly
- C-spine injury
- Patients who need Rapid sequence induction
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Ajou university school of medicine
Suwon, Gyeonggi-do, 16499
About this study
Official title: A Comparison of Pentax AWS Videolaryngoscopy and Macintosh Laryngoscopy for Orotracheal Intubation in Children: a Randomized Controlled Trial
Comparison of Intubation using Pentax (Pentas AWS, Pentax, Tokyo, Japan) and Macintoch in pediatric patients
Read the detailed description
Pentax video laryngoscope (Pentas AWS, Pentax, Tokyo, Japan) is one of indirect optical laryngoscopes which is recently developed. Several studies have shown that the Pentax-AWS® provides full views of the glottis in the majority of patients. It makes successful tracheal intubation in patients after failed intubation using a Macintosh laryngoscope.
In pediatric patients who is expected to be difficult to intubate, Pentax makes successful intubation.
- Conditions
- Intubation;Difficult
- Being tested
- Pentax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PentaxDevice
Intubation using Pentax video laryngoscope in Pentax group
| Study group | Role | What they receive |
|---|---|---|
| Pentax group | Intubation using Pentax Receives: Device: Pentax | |
| Macintosh group | Intubation using Macintosh |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intubation time
from laryngoscope pass incisors to end tidal CO2 appears
Measured: less than 10 minute
Secondary outcomes (1)
Intubation difficulty score
IDS parameter is Number of attempts > 1 = N1 Number of operators >1 = N2 Number of alternative techniques = N3 Cormack and Lehane grade minus 1 = N4 Operator perception of lifting force required Normal N5 = 0 Greater than in routine practice N5=1 Laryngeal pressure applied Not applied N6=0 Applied N6=1 Vocal core mobility Abduction N7=0 Adduction \&/or impending tube passage N7=1 Total IDS = sum of scores N1~N7
Measured: less than 10 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2017
- Study start31 May 2017
- Primary completion5 Dec 2017
- Study completion8 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intubation;DifficultStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, In-kyong Yi, Ajou University School of Medicine
- Investigators
- Jong Yeop Kim, MD, Principal investigator, Ajou University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03118622
- Sponsor's protocol ID
- AJIRB-TEMP-TEMP-17-170
- Acronym
- Pentax
- Status last verified
- Jan 2018
- First submitted
- 13 Apr 2017
- Last updated
- 11 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yi IK, Kwak HJ, Kim KM, Ahn SH, Lee SY, Kim JY. Comparison of Pentax Airway Scope and Macintosh laryngoscope for orotracheal intubation in children: A randomised non-inferiority trial. Acta Anaesthesiol Scand. 2019 Aug;63(7):853-858. doi: 10.1111/aas.13368. Epub 2019 Mar 22.
PubMed 30900242
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Pentax AWS Videolaryngoscopy and Macintosh Laryngoscopy for Orotracheal Intubation in Children: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03118622
- Acronym / sponsor ID
- Pentax / AJIRB-TEMP-TEMP-17-170
- Conditions
- Intubation;Difficult
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Study start
- 31 May 2017 (actual)
- Primary completion
- 5 Dec 2017 (actual)
- Study completion
- 8 Jan 2018 (actual)
- First posted
- 18 Apr 2017 (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.
Comparison of Intubation using Pentax (Pentas AWS, Pentax, Tokyo, Japan) and Macintoch in pediatric patients
Detailed description
Pentax video laryngoscope (Pentas AWS, Pentax, Tokyo, Japan) is one of indirect optical laryngoscopes which is recently developed. Several studies have shown that the Pentax-AWS® provides full views of the glottis in the majority of patients. It makes successful tracheal intubation in patients after failed intubation using a Macintosh laryngoscope.
In pediatric patients who is expected to be difficult to intubate, Pentax makes successful intubation.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pentax group | – | Device: PentaxIntubation using Pentax |
| Macintosh group | – | –Intubation using Macintosh |
Who may qualify
- Ages
- 1 year to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Pediatric patients
Key inclusion criteria (2 listed)
- ASA 1, 2
- Scheduled surgery under general anesthesia
Key exclusion criteria (4 listed)
- Intraoral disease
- Congenital anomaly
- C-spine injury
- Patients who need Rapid sequence induction
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 |
|---|---|---|
| PentaxIntubation using Pentax video laryngoscope in Pentax group | Device | Pentax group |
Primary outcome
Intubation time
Time frame: less than 10 minute
from laryngoscope pass incisors to end tidal CO2 appears
1 secondary outcome
Intubation difficulty score
Time frame: less than 10 minute
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2018.
- Derived from this study: PubMed 30900242Yi IK, Kwak HJ, Kim KM, Ahn SH, Lee SY, Kim JY. Comparison of Pentax Airway Scope and Macintosh laryngoscope for orotracheal intubation in children: A randomised non-inferiority trial. Acta Anaesthesiol Scand. 2019 Aug;63(7):853-858. doi: 10.1111/aas.13368. Epub 2019 Mar 22.
- Individual participant dataSharing planned: No
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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.
Jong Yeop Kim, MD principal investigator
Ajou University School of Medicine
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 Intubation;Difficult, run by Ajou University School of Medicine at 1 site in South Korea.
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 4 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: finished, as of the sponsor's last update on 11 Jan 2018. 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 South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intubation time (time frame: less than 10 minute). 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 NCT03118622, which also lists 1 linked publication.
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 11 Jan 2018; AzTrials last refreshed its copy on 27 Oct 2026.