Intubation; Difficult or FailedNCT04936516
McGrath vs. C-MAC Video Laryngoscopy Comparison in Endotracheal Tube Insertion
A study testing Endotracheal intubation in people with Intubation; Difficult or Failed, run by Udayana University at 1 site in Indonesia.
Trial summary
Tracheal intubation is commonly performed using a standard Macintosh blade, but recently there has been advanced technology using video laryngoscopy (VL).In this modern era, there are various types of available VL to make it easier for anesthesiologists to perform intubation, especially in patients with difficult… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Intubation; Difficult or Failed
- What is being tested?
- Endotracheal intubation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Aug 2021to 14 Oct 2021
- 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
- Elective surgery patients without neck and face trauma
- Undergo surgery requiring general anesthesia with endotracheal intubation
- Patients with physical status ASA I-III
- Patients aged 18-65 years
- Nutritional status (BMI < 35 Kg/m2)
Who cannot join
- Patients refusal to be included in the study
- Patients with cervical spine instability
- Anatomical and structural abnormalities of the maxillary teeth
- Thyromental distance <6 cm and inter-incisor distance <3.5 cm
- History of difficult intubation
- LEMON criteria ≥ 3
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness Comparison Between McGrath and C-MAC Video Laryngoscope in Endotracheal Tube Insertion
Tracheal intubation is commonly performed using a standard Macintosh blade, but recently there has been advanced technology using video laryngoscopy (VL).In this modern era, there are various types of available VL to make it easier for anesthesiologists to perform intubation, especially in patients with difficult airway anatomy.
Various studies showed different results regarding the effectiveness of both C-MAC® and McGrath®, by assessing the comparison of the effectiveness, valuable information will be obtained for further consideration by experts in choosing the best tools in the future.
- Conditions
- Intubation; Difficult or Failed
- Being tested
- Endotracheal intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endotracheal intubationDevice
Endotracheal intubation using either McGrath or C-MAC video laryngoscopy
| Study group | Role | What they receive |
|---|---|---|
| McGrath Video Laryngoscope | Active comparator | Not described Receives: Device: Endotracheal intubation |
| C-MAC Video Laryngoscope | Active comparator | Not described Receives: Device: Endotracheal intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intubation time
Time required to perform intubation until endotracheal tube is properly positioned
Measured: From first intubation attempt until successful intubation, an average of one minute
Ease of intubation
Difficulty level of intubation, scores 1-2, 1=effortless, 2=difficult
Measured: From first intubation attempt until successful intubation, an average of two minutes
Secondary outcomes (3)
Number of intubation attempts
The number of times required for a successful intubation
Measured: From first intubation attempt until successful intubation, an average of one minute
Glottic visualization
Visualization of glottic assessed by the POGO (Percentage of Glottis Opening) score, 1=best, 4=worst
Measured: During first intubation attempt, an average of 30 seconds
Complications of intubation
Includes orotracheal trauma, presence of blood in the blades, laryngospasm, bradycardia
Measured: From first intubation attempt until successful intubation, an average of one minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2021
- Study start1 Aug 2021
- Primary completion30 Sep 2021
- Study completion14 Oct 2021
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
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Udayana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Ryalino, MD, Udayana University
- Investigators
- Tjokorda GA Senapathi, Dr, Study chair, Udayana UniversityJhoni P Pasaribu, Study director, Udayana UniversityChristopher Ryalino, Principal investigator, Udayana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04936516
- Sponsor's protocol ID
- UNUD-CTR-FK110621-001
- Status last verified
- Oct 2021
- First submitted
- 10 Jun 2021
- Last updated
- 19 Oct 2021
- 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 19 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness Comparison Between McGrath and C-MAC Video Laryngoscope in Endotracheal Tube Insertion
- ClinicalTrials.gov ID
- NCT04936516
- Acronym / sponsor ID
- UNUD-CTR-FK110621-001
- Conditions
- Intubation; Difficult or Failed
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Udayana UniversityUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 14 Oct 2021 (actual)
- First posted
- 23 Jun 2021 (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.
Tracheal intubation is commonly performed using a standard Macintosh blade, but recently there has been advanced technology using video laryngoscopy (VL).In this modern era, there are various types of available VL to make it easier for anesthesiologists to perform intubation, especially in patients with difficult airway anatomy.
Various studies showed different results regarding the effectiveness of both C-MAC® and McGrath®, by assessing the comparison of the effectiveness, valuable information will be obtained for further consideration by experts in choosing the best tools in the future.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| McGrath Video Laryngoscope | Active comparator | Device: Endotracheal intubation |
| C-MAC Video Laryngoscope | Active comparator | Device: Endotracheal intubation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Elective surgery patients without neck and face trauma
- Undergo surgery requiring general anesthesia with endotracheal intubation
- Patients with physical status ASA I-III
- Patients aged 18-65 years
- Nutritional status (BMI < 35 Kg/m2)
Key exclusion criteria (6 listed)
- Patients refusal to be included in the study
- Patients with cervical spine instability
- Anatomical and structural abnormalities of the maxillary teeth
- Thyromental distance <6 cm and inter-incisor distance <3.5 cm
- History of difficult intubation
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 |
|---|---|---|
| Endotracheal intubationEndotracheal intubation using either McGrath or C-MAC video laryngoscopy | Device | C-MAC Video Laryngoscope, McGrath Video Laryngoscope |
Primary outcome
Intubation time
Time frame: From first intubation attempt until successful intubation, an average of one minute
Time required to perform intubation until endotracheal tube is properly positioned
Ease of intubation
Time frame: From first intubation attempt until successful intubation, an average of two minutes
Difficulty level of intubation, scores 1-2, 1=effortless, 2=difficult
3 secondary outcomes
Number of intubation attempts
Time frame: From first intubation attempt until successful intubation, an average of one minute
Glottic visualization
Time frame: During first intubation attempt, an average of 30 seconds
Complications of intubation
Time frame: From first intubation attempt until successful intubation, an average of one minute
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 Oct 2021.
- 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.
Tjokorda GA Senapathi, Dr study chair
Udayana University
Jhoni P Pasaribu study director
Udayana University
Christopher Ryalino principal investigator
Udayana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endotracheal intubation in people with Intubation; Difficult or Failed, run by Udayana University at 1 site in Indonesia.
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 5 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 19 Oct 2021. 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 Indonesia. 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?
Intubation time (time frame: From first intubation attempt until successful intubation, an average of one minute). The study lists 2 primary outcomes in all. 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 Oct 2021.