Intubation;DifficultNCT03514745
Comparison of Lighted Stylet and GlideScope for Double-lumen Endobronchial Intubation
A study testing GlideScope and Lighted stylet in people with Intubation;Difficult, run by SMG-SNU Boramae Medical Center at 1 site in South Korea.
Trial summary
We evaluate the GlideScope and lighted stylet for DLT intubation in terms of the intubation time, number of intubation attempts, difficulty in DLT advancement towards the glottis, postoperative sore throat and hoarseness, and hemodynamic responses during intubation in patients with predicted difficult airways. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Intubation;Difficult
- What is being tested?
- GlideScope and Lighted stylet
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- 6 May 2018to May 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients undergoing thoracic surgery requiring endobronchial intubation for one-lung ventilation
Who cannot join
- presence of sore throat and hoarseness
- requirements for postoperative mechanical ventilation
- at risk of aspiration.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul Metropolitan Government Seoul National University Boramae Medical Center
Seoul, 156-707
Jin-Young Hwang, M.D., +82-2-870-2518, mistyblue15@naver.com
About this study
Official title: Comparison of Lighted Stylet and GlideScope for Double-lumen Endobronchial Intubation in Patients With a Predicted Difficult Airway
We evaluate the GlideScope and lighted stylet for DLT intubation in terms of the intubation time, number of intubation attempts, difficulty in DLT advancement towards the glottis, postoperative sore throat and hoarseness, and hemodynamic responses during intubation in patients with predicted difficult airways.
- Conditions
- Intubation;Difficult
- Being tested
- GlideScope, Lighted stylet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlideScopeDevice
Endobronchial intubation is performed using the GlideScope.
Lighted styletDevice
Endobronchial intubation is performed using a lighted stylet.
| Study group | Role | What they receive |
|---|---|---|
| GlideScope group | Active comparator | After the induction of anesthesia, endobronchial intubation is performed using the GlideScope. Receives: Device: GlideScope |
| Lighted stylet group | Experimental | After the induction of anesthesia, endobronchial intubation is performed using a lighted stylet. Receives: Device: Lighted stylet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intubation time taken for endobronchial intubation
Intubation time is defined as the time elapsed from picking up GlideScope or lighted stylet to confirmation of successful intubation by capnometry.
Measured: During endobronchial intubation
Secondary outcomes (5)
Number of intubation attempts
Total intubation attempts are counted.
Measured: During endobronchial intubation
Difficulty of DLT advancement towards the glottis
It is categorised as very easy, easy, difficult, and very difficult
Measured: During endobronchial intubation
Resistance to DLT insertion through the glottis
It is categorized as none, mild, and moderate
Measured: During endobronchial intubation
The incidence and severity of postoperative sore throat
It is quantified by using a 100-point numerical rating scale (NRS, 0 [no pain], 100 [worst pain imaginable]).
Measured: At 1 and 24 hours after surgery
The incidence and severity of postoperative hoarseness
Hoarseness is defined as a voice quality different from the preoperative voice and graded as follows: none (no hoarseness), mild (recognized by the patient), moderate (obvious to the investigator), and severe (aphonia).
Measured: At 1 and 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 posted2 May 2018
- Study start6 May 2018
- Primary completion30 Apr 2019 (estimated)
- Study completionMay 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SMG-SNU Boramae Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-Young Hwang, SMG-SNU Boramae Medical Center
- Investigators
- Jin-Young Hwang, M.D., Ph.D., Study director, Seoul Metropolitan Government Seoup National University Boramae Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03514745
- Sponsor's protocol ID
- 20171227
- Status last verified
- Jul 2018
- First submitted
- 20 Apr 2018
- Last updated
- 3 Jul 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Lighted Stylet and GlideScope for Double-lumen Endobronchial Intubation in Patients With a Predicted Difficult Airway
- ClinicalTrials.gov ID
- NCT03514745
- Acronym / sponsor ID
- 20171227
- Conditions
- Intubation;Difficult
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- SMG-SNU Boramae Medical CenterUniversity, hospital or other
- Study start
- 6 May 2018 (actual)
- Primary completion
- 30 Apr 2019 (estimated)
- Study completion
- May 2019 (estimated)
- First posted
- 2 May 2018 (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.
We evaluate the GlideScope and lighted stylet for DLT intubation in terms of the intubation time, number of intubation attempts, difficulty in DLT advancement towards the glottis, postoperative sore throat and hoarseness, and hemodynamic responses during intubation in patients with predicted difficult airways.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GlideScope group | Active comparator | Device: GlideScopeAfter the induction of anesthesia, endobronchial intubation is performed using the GlideScope. |
| Lighted stylet group | Experimental | Device: Lighted styletAfter the induction of anesthesia, endobronchial intubation is performed using a lighted stylet. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adult patients undergoing thoracic surgery requiring endobronchial intubation for one-lung ventilation
Key exclusion criteria (3 listed)
- presence of sore throat and hoarseness
- requirements for postoperative mechanical ventilation
- at risk of aspiration.
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 |
|---|---|---|
| GlideScopeEndobronchial intubation is performed using the GlideScope. | Device | GlideScope group |
| Lighted styletEndobronchial intubation is performed using a lighted stylet. | Device | Lighted stylet group |
Primary outcome
Intubation time taken for endobronchial intubation
Time frame: During endobronchial intubation
Intubation time is defined as the time elapsed from picking up GlideScope or lighted stylet to confirmation of successful intubation by capnometry.
5 secondary outcomes
Number of intubation attempts
Time frame: During endobronchial intubation
Difficulty of DLT advancement towards the glottis
Time frame: During endobronchial intubation
Resistance to DLT insertion through the glottis
Time frame: During endobronchial intubation
The incidence and severity of postoperative sore throat
Time frame: At 1 and 24 hours after surgery
The incidence and severity of postoperative hoarseness
Time frame: At 1 and 24 hours after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2018.
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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.
Jin-Young Hwang, M.D., Ph.D. study director
Seoul Metropolitan Government Seoup National University Boramae Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GlideScope and Lighted stylet in people with Intubation;Difficult, run by SMG-SNU Boramae Medical Center 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 1 inclusion and 3 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 3 Jul 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jin-Young Hwang, M.D., Ph.D. (82-2-870-2518, mistyblue15@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intubation time taken for endobronchial intubation (time frame: During endobronchial 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 3 Jul 2018.