Difficult IntubationNCT02805569
Comparison of Intubation Conditions of the Articulating Stylet and Intubating Stylet Guided Videolaryngoscopy
A study testing articulating stylet and conventional stylet in people with Difficult Intubation, run by Diskapi Teaching and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Indirect videolaryngoscopes provide an improved view of the glottis. Unfortunately enhanced video blade angulation leads to difficulty in passage of the endotracheal tube (ETT) towards the larynx around the steep blade angulation despite adequate visualization of the glottis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Difficult Intubation
- What is being tested?
- articulating stylet and conventional stylet
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jun 2016to Feb 2018
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA 1-2 physical status (Anticipated difficult airway) ADA scores >6 Elective surgery
Who cannot join
- ASA 3-4 physical status Immobilizedcervical spine
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ministry of Health Diskapi Yıldırım Beyazıt Training and Research Hospital Ankara, Turkey
Ankara, 06110
About this study
Official title: Comparison of Intubation Conditions of the Articulating Stylet and Intubating Stylet Guided Videolaryngoscopy in Patients With Difficult Airway
Indirect videolaryngoscopes provide an improved view of the glottis. Unfortunately enhanced video blade angulation leads to difficulty in passage of the endotracheal tube (ETT) towards the larynx around the steep blade angulation despite adequate visualization of the glottis. Pre-shaping the ETT with the rigit malleable stylet is recommended. The investigators hypothesized that using articulating stylet (AS) would enhance first attempt intubation, shorten the intubation time, reduce the possibility of the soft tissue trauma compared to conventional intubation stylet (IS) in patients with difficult airway .
Read the detailed description
Patients with known airway difficulty (anticipated difficult airway (ADA) score >6) will be included to the study.
All patients will receive general anesthesia for a variety of elective surgical procedure. Tracheal intubation will be performed by senior anesthesiologist. Patients will be intubated using AS-videolaryngoscope (n= 24) or IS-videolaryngoscope (n=24) randomly. Patients demographic details (age 18-65 yr, body mass index, ASA phisical status), ADA scores, Cormack-Lehane scores, intubation difficulty scores, intubation attempts, intubation time, hemodynamic variables, sore throat, anesthesiologists satisfaction will be recorded.
- Conditions
- Difficult Intubation
- Being tested
- articulating stylet, conventional stylet
- Keywords
- videolaryngoscope, intubation stylet, articulating stylet, difficult airway
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
articulating styletDevice
patient who intubated with articulating stylet
conventional styletDevice
patient who intubated with conventional stylet
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | articulating stylet Receives: Device: articulating stylet |
| group C | Active comparator | conventional stylet Receives: Device: conventional stylet |
What is being measured
The primary outcome is the main question the study is designed to answer.
intibation time
Total intubation time (second)
Measured: Through intubation completion, an avarage of 5 minutes
Secondary outcomes (1)
tracheal intubation attempts
number of intubation attempts
Measured: Through intubation completion, an avarage of 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionFeb 2018
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Difficult IntubationStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diskapi Teaching and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, derya özkan, Diskapi Teaching and Research Hospital
- Investigators
- Derya Özkan, MD, Principal investigator, Ministry of Health Diskapi Yıldırım Beyazıt Training and Research Hospital Ankara, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02805569
- Sponsor's protocol ID
- 27/28
- Status last verified
- Apr 2018
- First submitted
- 13 Jun 2016
- Last updated
- 3 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Adnet F, Borron SW, Racine SX, Clemessy JL, Fournier JL, Plaisance P, Lapandry C. The intubation difficulty scale (IDS): proposal and evaluation of a new score characterizing the complexity of endotracheal intubation. Anesthesiology. 1997 Dec;87(6):1290-7. doi: 10.1097/00000542-199712000-00005.
PubMed 9416711Suppan L, Tramer MR, Niquille M, Grosgurin O, Marti C. Alternative intubation techniques vs Macintosh laryngoscopy in patients with cervical spine immobilization: systematic review and meta-analysis of randomized controlled trials. Br J Anaesth. 2016 Jan;116(1):27-36. doi: 10.1093/bja/aev205. Epub 2015 Jun 30.
PubMed 26133898
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Intubation Conditions of the Articulating Stylet and Intubating Stylet Guided Videolaryngoscopy in Patients With Difficult Airway
- ClinicalTrials.gov ID
- NCT02805569
- Acronym / sponsor ID
- 27/28
- Conditions
- Difficult Intubation
- Keywords
- videolaryngoscope, intubation stylet, articulating stylet, difficult airway
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Diskapi Teaching and Research HospitalUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 20 Jun 2016 (estimated)
- 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.
Indirect videolaryngoscopes provide an improved view of the glottis. Unfortunately enhanced video blade angulation leads to difficulty in passage of the endotracheal tube (ETT) towards the larynx around the steep blade angulation despite adequate visualization of the glottis. Pre-shaping the ETT with the rigit malleable stylet is recommended. The investigators hypothesized that using articulating stylet (AS) would enhance first attempt intubation, shorten the intubation time, reduce the possibility of the soft tissue trauma compared to conventional intubation stylet (IS) in patients with difficult airway .
Detailed description
Patients with known airway difficulty (anticipated difficult airway (ADA) score >6) will be included to the study.
All patients will receive general anesthesia for a variety of elective surgical procedure. Tracheal intubation will be performed by senior anesthesiologist. Patients will be intubated using AS-videolaryngoscope (n= 24) or IS-videolaryngoscope (n=24) randomly. Patients demographic details (age 18-65 yr, body mass index, ASA phisical status), ADA scores, Cormack-Lehane scores, intubation difficulty scores, intubation attempts, intubation time, hemodynamic variables, sore throat, anesthesiologists satisfaction will be recorded.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Device: articulating styletarticulating stylet |
| group C | Active comparator | Device: conventional styletconventional stylet |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA 1-2 physical status (Anticipated difficult airway) ADA scores >6 Elective surgery
Key exclusion criteria (1 listed)
- ASA 3-4 physical status Immobilizedcervical spine
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 |
|---|---|---|
| articulating styletpatient who intubated with articulating stylet | Device | Group A |
| conventional styletpatient who intubated with conventional stylet | Device | group C |
Primary outcome
intibation time
Time frame: Through intubation completion, an avarage of 5 minutes
Total intubation time (second)
1 secondary outcome
tracheal intubation attempts
Time frame: Through intubation completion, an avarage of 5 minutes
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 3 Apr 2018.
- Results publication: PubMed 9416711Adnet F, Borron SW, Racine SX, Clemessy JL, Fournier JL, Plaisance P, Lapandry C. The intubation difficulty scale (IDS): proposal and evaluation of a new score characterizing the complexity of endotracheal intubation. Anesthesiology. 1997 Dec;87(6):1290-7. doi: 10.1097/00000542-199712000-00005.
- Results publication: PubMed 26133898Suppan L, Tramer MR, Niquille M, Grosgurin O, Marti C. Alternative intubation techniques vs Macintosh laryngoscopy in patients with cervical spine immobilization: systematic review and meta-analysis of randomized controlled trials. Br J Anaesth. 2016 Jan;116(1):27-36. doi: 10.1093/bja/aev205. Epub 2015 Jun 30.
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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.
Derya Özkan, MD principal investigator
Ministry of Health Diskapi Yıldırım Beyazıt Training and Research Hospital Ankara, Turkey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing articulating stylet and conventional stylet in people with Difficult Intubation, run by Diskapi Teaching and Research Hospital at 1 site in Turkey (Türkiye).
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 1 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 3 Apr 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 Turkey (Türkiye). 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?
intibation time (time frame: Through intubation completion, an avarage of 5 minutes). 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 NCT02805569, which also lists 2 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 3 Apr 2018.