Intubation; Difficult or FailedNCT06119360
Comparison of Two Different Lightwand Intubation Techniques in Cervical Immobilized Patients
A study testing Face-to-face approach and Conventional approach in people with Intubation; Difficult or Failed, run by Kyung Hee University Hospital at Gangdong at 1 site in South Korea.
Trial summary
This study compares two different approaches of lightwand intubation techniques in cervical immobilized patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intubation; Difficult or Failed
- What is being tested?
- Face-to-face approach and Conventional approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 Dec 2018to 31 Aug 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adults with American Society of Anesthesiologists physical status 1-3
- patients who received scheduled spine surgery under general anesthesia
Who cannot join
- patients with body mass index <18.5 kg/m2 or >35.0 kg/m2,
- patients who previously had head and neck surgery,
- patients who are at high risk of aspiration,
- patients with pathologic conditions such as tumors, polyps, or inflammation in the airway,
- patients who cannot sit due to severe spine deformity,
- patients who have compromised cardiopulmonary function patients with clinically significant neurovascular disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Intubation Success Rate Between Two Techniques Using Lightwand in Patients Undergoing Spine Surgery: Conventional vs. Face-to-face Technique
This study compares two different approaches of lightwand intubation techniques in cervical immobilized patients.
Read the detailed description
This study compares two approaches in lightwand intubation techniques in cervical immobilized patients. One is a conventional approach that involves scooping movement with mandible protraction. The other is a face-to-face approach that inserts lightwand with a front-facing position. This study is conducted as a randomized, prospective, single-blinded design.
- Conditions
- Intubation; Difficult or Failed
- Being tested
- Face-to-face approach, Conventional approach
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Face-to-face approachProcedure or surgery
A front-facing approach and insert the lightwand following the patient's tongue base curvature without scooping movement
Conventional approachProcedure or surgery
Patients were positioned supine and the intubator stood above the patient's head. Opening the mouth and slightly pulling the mandible with one hand, the intubator inserted the lightwand-tracheal tube assembly at midline into the patient's mouth under the ambient light being turned off. To identify the location of the lighted tip, the intubator could move the lightwand back and forth gently, Once the red light of the tip was located at the midline of the patient's neck, the pre-launched tube was inserted smoothly into the patient's airway unless there was no resistance
| Study group | Role | What they receive |
|---|---|---|
| Group Conventional | Other | Conventional approach using group in lightwand intubation Receives: Procedure: Conventional approach |
| Group Face-to-Face | Other | Face-to-face approach using group in lightwand intubation Receives: Procedure: Face-to-face approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Initial success rate
Intubation success rate at the first attempt
Measured: during intubation
Secondary outcomes (1)
Intubation time
Total time to the successful intubation
Measured: during intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start12 Dec 2018
- Primary completion13 Feb 2019
- Study completion31 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intubation; Difficult or FailedStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 176 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 Suh, Principal investigator, Kyung Hee University Hospital at Gangdong-gu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06119360
- Sponsor's protocol ID
- KHNMC 2018-10-011-002
- Status last verified
- Nov 2023
- First submitted
- 30 Oct 2023
- Last updated
- 7 Nov 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 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Intubation Success Rate Between Two Techniques Using Lightwand in Patients Undergoing Spine Surgery: Conventional vs. Face-to-face Technique
- ClinicalTrials.gov ID
- NCT06119360
- Acronym / sponsor ID
- KHNMC 2018-10-011-002
- Conditions
- Intubation; Difficult or Failed
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Kyung Hee University Hospital at GangdongUniversity, hospital or other
- Study start
- 12 Dec 2018 (actual)
- Primary completion
- 13 Feb 2019 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 7 Nov 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.
This study compares two different approaches of lightwand intubation techniques in cervical immobilized patients.
Detailed description
This study compares two approaches in lightwand intubation techniques in cervical immobilized patients. One is a conventional approach that involves scooping movement with mandible protraction. The other is a face-to-face approach that inserts lightwand with a front-facing position. This study is conducted as a randomized, prospective, single-blinded design.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Conventional | Other | Procedure: Conventional approachConventional approach using group in lightwand intubation |
| Group Face-to-Face | Other | Procedure: Face-to-face approachFace-to-face approach using group in lightwand intubation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- adults with American Society of Anesthesiologists physical status 1-3
- patients who received scheduled spine surgery under general anesthesia
Key exclusion criteria (6 listed)
- patients with body mass index <18.5 kg/m2 or >35.0 kg/m2,
- patients who previously had head and neck surgery,
- patients who are at high risk of aspiration,
- patients with pathologic conditions such as tumors, polyps, or inflammation in the airway,
- patients who cannot sit due to severe spine deformity,
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 |
|---|---|---|
| Face-to-face approachA front-facing approach and insert the lightwand following the patient's tongue base curvature without scooping movement | Procedure or surgery | Group Face-to-Face |
| Conventional approachPatients were positioned supine and the intubator stood above the patient's head. Opening the mouth and slightly pulling the mandible with one hand, the intubator inserted the lightwand-tracheal tube assembly at midline into the patient's mouth under the ambient light being turned off. To identify the location of the lighted tip, the intubator could move the lightwand back and forth gently, Once the red light of the tip was located at the midline of the patient's neck, the pre-launched tube was inserted smoothly into the patient's airway unless there was no resistance | Procedure or surgery | Group Conventional |
Primary outcome
Initial success rate
Time frame: during intubation
Intubation success rate at the first attempt
1 secondary outcome
Intubation time
Time frame: during intubation
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 7 Nov 2023.
- Individual participant dataSharing planned: No
Related trials for Intubation; Difficult or Failed
Not yet recruitingObservational study
Can the "Face Index"; an Anthropometric Measurement, Predict Difficult Laryngoscopy and Intubation?
Anesthesia Intubation Complication, Laryngoscopy
RecruitingObservational study
PrediSuisse: Automatized Assessment of Difficult Airway
Anesthesia, Intubation; Difficult or Failed
RecruitingObservational study
Difficult Airway Prediction by Integrating STOP-BANG Criteria
Ventilatory Defect, Intubation; Difficult or Failed
RecruitingObservational study
Improving Safety and Quality of Tracheal Intubation Practice in Pediatric ICUs
Failed or Difficult Intubation, Sequela, Intubation; Difficult
Active, not recruitingObservational study
Data-driven Development of a Core Dataset for Difficult Airway Alerts
Airway Management, Intubation; Difficult or Failed
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 Suh principal investigator
Kyung Hee University Hospital at Gangdong-gu
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Face-to-face approach and Conventional approach in people with Intubation; Difficult or Failed, 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 6 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 7 Nov 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?
Initial success rate (time frame: during intubation). 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 7 Nov 2023.