VideolaryngoscopyD&XbladeNCT03826706
Comparison Of Videolaryngoscopes In Double Lumen Tube
A study testing C-MAC Videolaryngoscope D blade and McGrath MAC Videolaryngoscope X3 blade in people with Videolaryngoscopy and Double Lumen Tube, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
Along with the technological advances in medicine, videolaryngoscope is the most commonly preferred technique for intubation with double lumen tube. The use of Storz C-MAC D Blade and McGrath MAC X3 Blade videolaryngoscope were compared in intubation of single lung ventilation patients who underwent chest surgery in… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Videolaryngoscopy, Double Lumen Tube, One-lung Ventilation
- What is being tested?
- C-MAC Videolaryngoscope D blade and McGrath MAC Videolaryngoscope X3 blade
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Feb 2019to 10 Apr 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiology score III,
- 18-65 years,
- BMI> 40
- Patients who was intubated with double lumen tube.
Who cannot join
- American Society of Anesthesiology IV,
- Under 18 years,
- Over 65 years,
- Under BMI<40
- Obstetric patients,
- Uncontrolled cerebrovascular disease,
- Patients who refused written informed consent forms
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Of Storz C-Mac® D Blade Videolaryngoscope With McGrath® X3 Blade Videolaryngoscope In Double Lumen Tube Patients
Along with the technological advances in medicine, videolaryngoscope is the most commonly preferred technique for intubation with double lumen tube. The use of Storz C-MAC D Blade and McGrath MAC X3 Blade videolaryngoscope were compared in intubation of single lung ventilation patients who underwent chest surgery in terms of duration of intubation, hemodynamic response and intubation-induced complications.
Read the detailed description
It is very important for anesthesiologists to evaluate and make the airway safe in order to start and continue surgical operations. Endotracheal intubation has many important reasons such as ensuring airway control safely during surgical procedure, increasing the depth of anesthesia, need interventions for surgical or anesthetic complications, reduction of dead space, reduction of respiratory effort and prevention of aspiration risk. Videolaryngoscope, developed in recent years and beginning to take place in the algorithms, facilitate difficult airway management and hence intubation.
The use of videolaryngoscope in patients with intubation such as double lumen tube, has been frequently reported in the literature. McGrath videolaryngoscope has a high-resolution video camera, a length-adjustable angle blade, and a light source at the tip of the blade. At the same time, the C-MAC videolaryngoscope is another advanced videolaryngoscope with a better quality video and camera system and improves the performance of videolaryngoscope with some technological changes. In this prospective controlled clinical study, the purpose is to compare C-MAC videolaryngoscope with D blade and McGrath MAC videolaryngoscope with X3 blade in respect to duration of intubation, haemodynamic response, and adverse events associated with intubation of patients undergoing lung surgery.
- Conditions
- Videolaryngoscopy, Double Lumen Tube, One-lung Ventilation
- Being tested
- C-MAC Videolaryngoscope D blade, McGrath MAC Videolaryngoscope X3 blade
- Keywords
- Videolaryngoscopy, Double lumen tube, One-lung ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C-MAC Videolaryngoscope D bladeDevice
C-MAC videolaryngoscope D blade An intubating device that is used for endotracheal intubation. Endotracheal intubation was applied by anesthesiologist with C-MAC videolaryngoscope.
McGrath MAC Videolaryngoscope X3 bladeDevice
McGrath MAC videolaryngoscope X blade An intubating device that is used for endotracheal intubation. Endotracheal intubation was applied by anesthesiologist with McGrath MAC videolaryngoscope.
| Study group | Role | What they receive |
|---|---|---|
| C-MAC Videolaryngoscope D blade | Active comparator | Patients was intubated with C-MAC videolaryngoscope D blade. Receives: Device: C-MAC Videolaryngoscope D blade; Device: McGrath MAC Videolaryngoscope X3 blade |
| McGrath MAC Videolaryngoscope X3 blade | Active comparator | Patients was intubated with McGrath MAC Videolaryngoscope X3 blade Receives: Device: C-MAC Videolaryngoscope D blade; Device: McGrath MAC Videolaryngoscope X3 blade |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to intubation
Time to intubation was defined as the time from when the anesthesiologist picked up the videolaryngoscope to when the anesthesiologist successfully placed the endotracheal tube through the vocal cords
Measured: From beginning of holding videolaryngoscope to seeing two meaningful end-tidal carbon dioxide levels up to 3 minutes
Secondary outcomes (3)
Heart Rate
Heart Rate
Measured: From beginning of Anesthesia induction to 5th minutes of intubation
Mean Arterial Pressure
Mean Arterial Pressure
Measured: At beginning of Anesthesia induction, 1st, 2nd, 3th and 5th minutes of intubation
Adverse Events
Bleeding in the mouth, edema in the mouth, burst of intubation tube cuff, external laryngeal press, presence of head position change, laryngospasm, hypoxia, hoarseness, throat ache
Measured: During the first 24 hour postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2019
- Study start15 Feb 2019 (estimated)
- Primary completion30 Mar 2019 (estimated)
- Study completion10 Apr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VideolaryngoscopyStudies of the same condition, open and under way.
- More trials run by Inonu UniversityThe sponsor's other registered studies.
- 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmet Selim Ozkan, Inonu University
- Investigators
- Ahmet Selim Ozkan, Study director, Inonu University Medical Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03826706
- Sponsor's protocol ID
- Asozkan 4
- Acronym
- D&Xblade
- Status last verified
- Feb 2019
- First submitted
- 30 Jan 2019
- Last updated
- 5 Feb 2019
- 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 5 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Of Storz C-Mac® D Blade Videolaryngoscope With McGrath® X3 Blade Videolaryngoscope In Double Lumen Tube Patients
- ClinicalTrials.gov ID
- NCT03826706
- Acronym / sponsor ID
- D&Xblade / Asozkan 4
- Conditions
- Videolaryngoscopy, Double Lumen Tube, One-lung Ventilation
- Keywords
- Videolaryngoscopy, Double lumen tube, One-lung ventilation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 15 Feb 2019 (estimated)
- Primary completion
- 30 Mar 2019 (estimated)
- Study completion
- 10 Apr 2019 (estimated)
- First posted
- 1 Feb 2019 (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.
Along with the technological advances in medicine, videolaryngoscope is the most commonly preferred technique for intubation with double lumen tube. The use of Storz C-MAC D Blade and McGrath MAC X3 Blade videolaryngoscope were compared in intubation of single lung ventilation patients who underwent chest surgery in terms of duration of intubation, hemodynamic response and intubation-induced complications.
Detailed description
It is very important for anesthesiologists to evaluate and make the airway safe in order to start and continue surgical operations. Endotracheal intubation has many important reasons such as ensuring airway control safely during surgical procedure, increasing the depth of anesthesia, need interventions for surgical or anesthetic complications, reduction of dead space, reduction of respiratory effort and prevention of aspiration risk. Videolaryngoscope, developed in recent years and beginning to take place in the algorithms, facilitate difficult airway management and hence intubation.
The use of videolaryngoscope in patients with intubation such as double lumen tube, has been frequently reported in the literature. McGrath videolaryngoscope has a high-resolution video camera, a length-adjustable angle blade, and a light source at the tip of the blade. At the same time, the C-MAC videolaryngoscope is another advanced videolaryngoscope with a better quality video and camera system and improves the performance of videolaryngoscope with some technological changes. In this prospective controlled clinical study, the purpose is to compare C-MAC videolaryngoscope with D blade and McGrath MAC videolaryngoscope with X3 blade in respect to duration of intubation, haemodynamic response, and adverse events associated with intubation of patients undergoing lung surgery.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| C-MAC Videolaryngoscope D blade | Active comparator | Device: C-MAC Videolaryngoscope D blade, Device: McGrath MAC Videolaryngoscope X3 bladePatients was intubated with C-MAC videolaryngoscope D blade. |
| McGrath MAC Videolaryngoscope X3 blade | Active comparator | Device: C-MAC Videolaryngoscope D blade, Device: McGrath MAC Videolaryngoscope X3 bladePatients was intubated with McGrath MAC Videolaryngoscope X3 blade |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- American Society of Anesthesiology score III,
- 18-65 years,
- BMI> 40
- Patients who was intubated with double lumen tube.
Key exclusion criteria (7 listed)
- American Society of Anesthesiology IV,
- Under 18 years,
- Over 65 years,
- Under BMI<40
- Obstetric patients,
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 |
|---|---|---|
| C-MAC Videolaryngoscope D bladeC-MAC videolaryngoscope D blade An intubating device that is used for endotracheal intubation. Endotracheal intubation was applied by anesthesiologist with C-MAC videolaryngoscope. | Device | C-MAC Videolaryngoscope D blade, McGrath MAC Videolaryngoscope X3 blade |
| McGrath MAC Videolaryngoscope X3 bladeMcGrath MAC videolaryngoscope X blade An intubating device that is used for endotracheal intubation. Endotracheal intubation was applied by anesthesiologist with McGrath MAC videolaryngoscope. | Device | C-MAC Videolaryngoscope D blade, McGrath MAC Videolaryngoscope X3 blade |
Primary outcome
Time to intubation
Time frame: From beginning of holding videolaryngoscope to seeing two meaningful end-tidal carbon dioxide levels up to 3 minutes
Time to intubation was defined as the time from when the anesthesiologist picked up the videolaryngoscope to when the anesthesiologist successfully placed the endotracheal tube through the vocal cords
3 secondary outcomes
Heart Rate
Time frame: From beginning of Anesthesia induction to 5th minutes of intubation
Mean Arterial Pressure
Time frame: At beginning of Anesthesia induction, 1st, 2nd, 3th and 5th minutes of intubation
Adverse Events
Time frame: During the first 24 hour postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2019.
- Individual participant dataSharing planned: No
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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.
Ahmet Selim Ozkan study director
Inonu University Medical Faculty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing C-MAC Videolaryngoscope D blade and McGrath MAC Videolaryngoscope X3 blade in people with Videolaryngoscopy and Double Lumen Tube, run by Inonu 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 4 inclusion and 7 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 5 Feb 2019. 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?
Results are not available in the source record.
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?
Time to intubation (time frame: From beginning of holding videolaryngoscope to seeing two meaningful end-tidal carbon dioxide levels up to 3 minutes). 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 5 Feb 2019.