Intubation; Difficult or FailedNCT06011967
Intubation with Different Angled Intubation Tubes Using C-macr D Blade Videolaringoscope;
A study testing Intubation using C-MAC D blade videolariyngoscope in people with Intubation; Difficult or Failed and Sore-throat, run by Yeditepe University at 1 site in Turkey (Türkiye).
Trial summary
In this study we compared post-operative sore throat, ease and time of intubation, hoarseness, subglottic damage and hemodynamic changes to orotracheal intubation using three different intubation stylets with C-MAC R videolaryngoscope D- blade. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Intubation; Difficult or Failed, Sore-throat, Hoarseness
- What is being tested?
- Intubation using C-MAC D blade videolariyngoscope
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2021to 13 Jun 2022
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ASA score I-II
- Elective operations
- Supine pozition
- 18-65 years
- No history of surgery in the last 6 months
- No history of airway related surgery
- No anticipated difficult airway
Who cannot join
- Abdomen, thorax, head-neck surgeries
- Smoker
- Chronic alcohol abuse
- Occupational inhaler agent exposure
- Patients with malignancies
- Patients with a history of radiotheraphy to head-neck region
Show all 10Show fewer
- Patients with congenital anomalies at head-neck region
- Patients with diagnosed abnormalites of head -neck movements
- Non-cooperatied patients
- Non-oriented patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intubation with Different Angled Intubation Tubes Using C-macr D Blade Videolaringoscope; Evaluation of the Effect on Post-operative Sore Throat, Ease and Time of Intubation, Hoarseness, Subglottic Damage and Hemodynamic Changes : a Prospective Randomized Study
In this study we compared post-operative sore throat, ease and time of intubation, hoarseness, subglottic damage and hemodynamic changes to orotracheal intubation using three different intubation stylets with C-MAC R videolaryngoscope D- blade.
Read the detailed description
In this study we compared the ease of intubation, time needed for intubation, subglottic damage, postoperaitve sore throat, hoarseness and hemodynamic response to orotracheal intubation using three different intubation stylets with C-MAC R videolaryngoscope D- blade. After the approval of the Ethics Committee, patients were randomized into three groups with closed envelope technique. In Group A endotracheal tube (ETT) is shaped into an angel of 90 degrees, in Group B 80 degrees and in Group C 60 degrees with three different stylets. Laryngoscopy was performed using D-Blade in all 3 groups. Heart rate and blood pressure before and after intubation, time from the entrance of the laryngoscope into the mouth to the passage of the vocal cords, time from the appearance of the cords to intubation, Cormack-Lehane (C-L) classification were recorded. Subglottic damage was examined with fiberoptic bronchoscope. Patients were evaluated regarding postoperative sore throat and hoarsness at 30 minutes, 4, 12, 24 hours postoperatively.
- Conditions
- Intubation; Difficult or Failed, Sore-throat, Hoarseness
- Being tested
- Intubation using C-MAC D blade videolariyngoscope
- Keywords
- Videolaryngoscope,, Intubation, C-MAC R Videolaryngoscope,, D- Blade, Subglottic damage, Postoperative sore throat,, Hoarsness
- Medical subject headings
- Pharyngitis, Hoarseness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intubation using C-MAC D blade videolariyngoscopeOther
all patients were intubated using the C-MAC D-Blade videolaryngoscope but for each group the intubation tubes were angled in different degrees. First group was intubated using the stylet of 60 degrees, second group was intubated using the stylet of 80 degrees and the third group was intubated using the stylet of 90 degrees.
| Study group | Role | What they receive |
|---|---|---|
| Group A : 90 degree | Active comparator | In this group patients were intubated using a 90 degree angled stylet with C-MAC D- Blade videolaryngoscope Receives: Other: Intubation using C-MAC D blade videolariyngoscope |
| Group B : 80 degree | Active comparator | In this group patients were intubated using a 80 degree angled stylet with C-MAC D- Blade videolaryngoscope Receives: Other: Intubation using C-MAC D blade videolariyngoscope |
| Group C: 60 degree | Active comparator | In this group patients were intubated using a 60 degree angled stylet with C-MAC D- Blade videolaryngoscope Receives: Other: Intubation using C-MAC D blade videolariyngoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
sore throat
For evaluation of sore throat, the patients were asked whether they had any throat pain. The severity of sore throat was graded as follows: 1: no sore throat, 2: minimal, 3: moderate, 4: severe
Measured: 30 minutes, 4 hour, 12 hour, 24 hour
Secondary outcomes (2)
Ease of intubation
For evaluation of the ease of intubation modified intubation difficulty score was used.
Measured: 2 minutes
Subglottic damage
For evaluation of subglottic damage 4-point scaled subglottic damage score was used. grade 0, normal; grade 1, mucosal hyperaemia and oedema and/or slight submucosal haematoma; grade 2, moderately submucosal haematoma; grade 3, mucosal laceration and/or mucosal bleeding
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2023
- Study start15 Mar 2021
- Primary completion12 Jun 2022
- Study completion13 Jun 2022
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In this study we compared the ease of intubation, time needed for intubation, subglottic damage, postoperaitve sore throat, hoarseness and hemodynamic response to orotracheal intubation using three different angled intubation stylets with C-MAC R videolaryngoscope D- blade.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yeditepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alkım Gizem Yılmaz Selimoğlu, Principal investigator, Yeditepe UniversityFerdi Menda, Prof., Study director, yYeditepe Universitu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06011967
- Sponsor's protocol ID
- E-66175679-514.04.01-788907
- Status last verified
- Aug 2023
- First submitted
- 11 Aug 2023
- Last updated
- 19 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intubation with Different Angled Intubation Tubes Using C-macr D Blade Videolaringoscope; Evaluation of the Effect on Post-operative Sore Throat, Ease and Time of Intubation, Hoarseness, Subglottic Damage and Hemodynamic Changes : a Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT06011967
- Acronym / sponsor ID
- E-66175679-514.04.01-788907
- Conditions
- Intubation; Difficult or Failed, Sore-throat, Hoarseness
- Keywords
- Videolaryngoscope,, Intubation, C-MAC R Videolaryngoscope,, D- Blade, Subglottic damage, Postoperative sore throat,, Hoarsness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Yeditepe UniversityUniversity, hospital or other
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 12 Jun 2022 (actual)
- Study completion
- 13 Jun 2022 (actual)
- First posted
- 25 Aug 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.
In this study we compared post-operative sore throat, ease and time of intubation, hoarseness, subglottic damage and hemodynamic changes to orotracheal intubation using three different intubation stylets with C-MAC R videolaryngoscope D- blade.
Detailed description
In this study we compared the ease of intubation, time needed for intubation, subglottic damage, postoperaitve sore throat, hoarseness and hemodynamic response to orotracheal intubation using three different intubation stylets with C-MAC R videolaryngoscope D- blade. After the approval of the Ethics Committee, patients were randomized into three groups with closed envelope technique. In Group A endotracheal tube (ETT) is shaped into an angel of 90 degrees, in Group B 80 degrees and in Group C 60 degrees with three different stylets. Laryngoscopy was performed using D-Blade in all 3 groups. Heart rate and blood pressure before and after intubation, time from the entrance of the laryngoscope into the mouth to the passage of the vocal cords, time from the appearance of the cords to intubation, Cormack-Lehane (C-L) classification were recorded. Subglottic damage was examined with fiberoptic bronchoscope. Patients were evaluated regarding postoperative sore throat and hoarsness at 30 minutes, 4, 12, 24 hours postoperatively.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- In this study we compared the ease of intubation, time needed for intubation, subglottic damage, postoperaitve sore throat, hoarseness and hemodynamic response to orotracheal intubation using three different angled intubation stylets with C-MAC R videolaryngoscope D- blade.
| Arm | Type | Receives |
|---|---|---|
| Group A : 90 degree | Active comparator | Other: Intubation using C-MAC D blade videolariyngoscopeIn this group patients were intubated using a 90 degree angled stylet with C-MAC D- Blade videolaryngoscope |
| Group B : 80 degree | Active comparator | Other: Intubation using C-MAC D blade videolariyngoscopeIn this group patients were intubated using a 80 degree angled stylet with C-MAC D- Blade videolaryngoscope |
| Group C: 60 degree | Active comparator | Other: Intubation using C-MAC D blade videolariyngoscopeIn this group patients were intubated using a 60 degree angled stylet with C-MAC D- Blade videolaryngoscope |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- ASA score I-II
- Elective operations
- Supine pozition
- 18-65 years
- No history of surgery in the last 6 months
Key exclusion criteria (10 listed)
- Abdomen, thorax, head-neck surgeries
- Smoker
- Chronic alcohol abuse
- Occupational inhaler agent exposure
- Patients with malignancies
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 |
|---|---|---|
| Intubation using C-MAC D blade videolariyngoscopeall patients were intubated using the C-MAC D-Blade videolaryngoscope but for each group the intubation tubes were angled in different degrees. First group was intubated using the stylet of 60 degrees, second group was intubated using the stylet of 80 degrees and the third group was intubated using the stylet of 90 degrees. | Other | Group A : 90 degree, Group B : 80 degree, Group C: 60 degree |
Primary outcome
sore throat
Time frame: 30 minutes, 4 hour, 12 hour, 24 hour
For evaluation of sore throat, the patients were asked whether they had any throat pain. The severity of sore throat was graded as follows: 1: no sore throat, 2: minimal, 3: moderate, 4: severe
2 secondary outcomes
Ease of intubation
Time frame: 2 minutes
Subglottic damage
Time frame: 2 hours
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 19 Nov 2024.
- Individual participant dataSharing planned: Undecided
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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.
Alkım Gizem Yılmaz Selimoğlu principal investigator
Yeditepe University
Ferdi Menda, Prof. study director
yYeditepe Universitu
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intubation using C-MAC D blade videolariyngoscope in people with Intubation; Difficult or Failed and Sore-throat, run by Yeditepe University 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 7 inclusion and 10 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 19 Nov 2024. 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?
sore throat (time frame: 30 minutes, 4 hour, 12 hour, 24 hour). 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 19 Nov 2024.