Intubation ComplicationNCT04948294
Comparison of the Intubation Condition Between Two Different Types of Video Laryngoscope Blades
A study testing Channeled blade and Non-channeled blade in people with Intubation Complication, run by Kyung Hee University Hospital at Gangdong at 1 site in South Korea.
Trial summary
The present study compares two different types of videolaryngoscope blade, which is a channeled and non-channeled blade. The purpose of the study is to investigate the effect of the type of videolaryngoscope blade on the intubation condition. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Intubation Complication
- What is being tested?
- Channeled blade and Non-channeled blade
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteSouth Korea
- Study dates
- 22 Aug 2018to 31 Dec 2021
- Phase
- Interventional
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients receiving tracheal intubation for general anesthesia
- Patients with physical status 1, 2, or 3 by American Society of Anesthesiologists Physical Status.
Who cannot join
- Body mass index <18.5 kg/m2 or >35 kg/m2
- Patients with a history of airway surgery
- Patients with increased risk of aspiration
- Patients who have any pathology (polyp, tumor, or inflammation) in the upper airway and larynx
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Intubation Condition Between Using Two Types of Blade in Patients Receiving Tracheal Intubation Using Videolaryngoscope: Channeled Blade vs. Non-channeled Blade
The present study compares two different types of videolaryngoscope blade, which is a channeled and non-channeled blade. The purpose of the study is to investigate the effect of the type of videolaryngoscope blade on the intubation condition.
Read the detailed description
In tracheal intubation for general anesthesia, one of the two types of the blade during a video laryngoscopy can be used, one is a channeled blade that has a channel for tracheal tube launching, the other is a non-channeled blade. In the present study, the outcomes by using two types of the videolaryngoscope blade such as the intubation condition, intubation time, first-pass rate, and the incidence of intubation-related complications were compared.
- Conditions
- Intubation Complication
- Being tested
- Channeled blade, Non-channeled blade
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Channeled bladeDevice
In the present group, a tracheal tube was launched in the channel of the blade before tracheal intubation
Non-channeled bladeDevice
In the present group, a tracheal tube was not launched in the videolaryngoscope blade before tracheal intubation
| Study group | Role | What they receive |
|---|---|---|
| Channeled group | Experimental | Group of patients using a channeled blade for videolaryngoscopy Receives: Device: Channeled blade |
| Non-channeled group | Active comparator | Group of patients using a non-channeled blade (standard type) for videolaryngoscopy Receives: Device: Non-channeled blade |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intubation time
the time for tracheal intubation
Measured: Immediately after tracheal intubation completed
Secondary outcomes (2)
First-pass rate
the success rate of tracheal intubation with one attempt
Measured: Immediately after tracheal intubation completed
Intubation-related complications
the incidence of overall complications related with tracheal intubation
Measured: within 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2021
- Study start22 Aug 2018
- Primary completion15 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intubation ComplicationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients requiring tracheal intubation for general anesthesia
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyung Hee University Hospital at Gangdong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyungseok Seo, Kyung Hee University Hospital at Gangdong
- Investigators
- Hyungseok Seo, MD, PhD, Principal investigator, Kyung Hee University Hospital at Gangdong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04948294
- Sponsor's protocol ID
- KHNMC 2019-07-020-001
- Status last verified
- Oct 2023
- First submitted
- 26 Jun 2021
- Last updated
- 27 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Intubation Condition Between Using Two Types of Blade in Patients Receiving Tracheal Intubation Using Videolaryngoscope: Channeled Blade vs. Non-channeled Blade
- ClinicalTrials.gov ID
- NCT04948294
- Acronym / sponsor ID
- KHNMC 2019-07-020-001
- Conditions
- Intubation Complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Kyung Hee University Hospital at GangdongUniversity, hospital or other
- Study start
- 22 Aug 2018 (actual)
- Primary completion
- 15 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 1 Jul 2021 (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 present study compares two different types of videolaryngoscope blade, which is a channeled and non-channeled blade. The purpose of the study is to investigate the effect of the type of videolaryngoscope blade on the intubation condition.
Detailed description
In tracheal intubation for general anesthesia, one of the two types of the blade during a video laryngoscopy can be used, one is a channeled blade that has a channel for tracheal tube launching, the other is a non-channeled blade. In the present study, the outcomes by using two types of the videolaryngoscope blade such as the intubation condition, intubation time, first-pass rate, and the incidence of intubation-related complications were compared.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients requiring tracheal intubation for general anesthesia
| Arm | Type | Receives |
|---|---|---|
| Channeled group | Experimental | Device: Channeled bladeGroup of patients using a channeled blade for videolaryngoscopy |
| Non-channeled group | Active comparator | Device: Non-channeled bladeGroup of patients using a non-channeled blade (standard type) for videolaryngoscopy |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients receiving tracheal intubation for general anesthesia
- Patients with physical status 1, 2, or 3 by American Society of Anesthesiologists Physical Status.
Key exclusion criteria (4 listed)
- Body mass index <18.5 kg/m2 or >35 kg/m2
- Patients with a history of airway surgery
- Patients with increased risk of aspiration
- Patients who have any pathology (polyp, tumor, or inflammation) in the upper airway and larynx
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 |
|---|---|---|
| Channeled bladeIn the present group, a tracheal tube was launched in the channel of the blade before tracheal intubation | Device | Channeled group |
| Non-channeled bladeIn the present group, a tracheal tube was not launched in the videolaryngoscope blade before tracheal intubation | Device | Non-channeled group |
Primary outcome
Intubation time
Time frame: Immediately after tracheal intubation completed
the time for tracheal intubation
2 secondary outcomes
First-pass rate
Time frame: Immediately after tracheal intubation completed
Intubation-related complications
Time frame: within 24 hours after surgery
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 27 Oct 2023.
- Individual participant dataSharing planned: No
Related trials for Intubation Complication
Recruiting
Smart Checklist Implementation for Pediatric Tracheal Intubations in the ICU- Multicenter Study
Intubation Complication
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The ED-AWARENESS-2 Trial
Awareness, Mechanical Ventilation
RecruitingObservational study
Cardiovascular History and Hemodynamic Complications After Intubation in ICU
Hemodynamic Complications
Not yet recruiting
Postoperative Pulmonary Complications After Use of Supraglottic Airway Devices and Neuromuscular Blockade
Postoperative Pulmonary Complications
Not yet recruiting
Establish Whether Hyperangulated Videolaryngoscopy (HAVL) Can be Used to Facilitate Tracheal Intubation Effectively and Safely in Unselected Adult Patients; Describe the Population in Whom HAVL Fails to Facilitate Tracheal Intubation Successfully, Identifying Any Contributory Characteristics.
Intubation Skill, Intubation Complications
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.
Hyungseok Seo, MD, PhD principal investigator
Kyung Hee University Hospital at Gangdong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Channeled blade and Non-channeled blade in people with Intubation Complication, run by Kyung Hee University Hospital at Gangdong 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 27 Oct 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 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: Immediately after tracheal intubation completed). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Oct 2023.