Difficult Mask VentilationNCT04759300
Effectiveness of C-MAC Video-stylet Versus C-MAC D- Blade Video-laryngoscope for Tracheal Intubation
A study testing C-MAC VS and C-MAC VL D -blade in people with Difficult Mask Ventilation and Difficult Intubation, run by Alexandria University at 1 site in Egypt.
Trial summary
Videolaryngoscopy provides a better laryngeal view and do not need airway alignment for tracheal intubation. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Difficult Mask Ventilation, Difficult Intubation
- What is being tested?
- C-MAC VS and C-MAC VL D -blade
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jan 2022to Jul 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients with BMI ≥ 30 kg/m2,
- presence of any predictors of difficult intubation;
- Mallampati score > =3;
- inter-incisor distance < 3 cm;
- thyromental distance < 6 cm;
- neck extension < 80°from neck flexion;
- cervical spine instability; history of difficult endotracheal intubation or difficult mask ventilation
Who cannot join
- patients have increased risk of pulmonary aspiration;
- have significant medical diseases in term of cardiac, respiratory, hepatic, renal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of C-MAC Video-stylet Versus C-MAC D- Blade Video-laryngoscope for Tracheal Intubation in Patients With Predicted Difficult Airway: Randomized Comparative Study
Videolaryngoscopy provides a better laryngeal view and do not need airway alignment for tracheal intubation.
Read the detailed description
The C-MAC-VS can be connected easily to the same C- MAC monitor and Pocket Monitor without requiring any additional light source and camera. This device is great for cases with limited mouth opening, airway obstruction and difficult intubation. C-MAC-VS has no lumens so it's very easy to clean and it can accommodates a size ETT 6.0 and greater.
- Conditions
- Difficult Mask Ventilation, Difficult Intubation
- Being tested
- C-MAC VS, C-MAC VL D -blade
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C-MAC VSDevice
patients undergoing tracheal intubation using the C-MAC VS
C-MAC VL D -bladeDevice
patients undergoing intubation using the C-MAC VL D-blade.
| Study group | Role | What they receive |
|---|---|---|
| Group C-MAC VS | Active comparator | patients undergoing tracheal intubation using the C-MAC VS. Receives: Device: C-MAC VS |
| Group C-MAC VL D -blade | Placebo comparator | patients undergoing intubation using the C-MAC VL D-blade. Receives: Device: C-MAC VL D -blade |
What is being measured
The primary outcome is the main question the study is designed to answer.
duration of intubation procedure
assess duration of intubation procedure by using C-MAC VS versus C-MAC D-blade in patients with anticipated difficult airway.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2021
- Study start10 Jan 2022
- Primary completionMay 2022 (estimated)
- Study completionJul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Difficult Mask VentilationStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The patients will be randomly assigned into two equal groups using computer-generated randomization technique. Group C-MAC VS (VS group) included patients undergoing tracheal intubation using the C-MAC VS. Group C-MAC VL D -blade (D group) included patients undergoing intubation using the C-MAC VL D-blade.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, rehab zayed, Alexandria University
- Investigators
- rehab A. Abd Elaziz, Ass.Prof., Principal investigator, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04759300
- Sponsor's protocol ID
- 0304844
- Status last verified
- May 2022
- First submitted
- 15 Feb 2021
- Last updated
- 1 Jun 2022
- 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 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of C-MAC Video-stylet Versus C-MAC D- Blade Video-laryngoscope for Tracheal Intubation in Patients With Predicted Difficult Airway: Randomized Comparative Study
- ClinicalTrials.gov ID
- NCT04759300
- Acronym / sponsor ID
- 0304844
- Conditions
- Difficult Mask Ventilation, Difficult Intubation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- May 2022 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 18 Feb 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.
Videolaryngoscopy provides a better laryngeal view and do not need airway alignment for tracheal intubation.
Detailed description
The C-MAC-VS can be connected easily to the same C- MAC monitor and Pocket Monitor without requiring any additional light source and camera. This device is great for cases with limited mouth opening, airway obstruction and difficult intubation. C-MAC-VS has no lumens so it's very easy to clean and it can accommodates a size ETT 6.0 and greater.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- The patients will be randomly assigned into two equal groups using computer-generated randomization technique. Group C-MAC VS (VS group) included patients undergoing tracheal intubation using the C-MAC VS. Group C-MAC VL D -blade (D group) included patients undergoing intubation using the C-MAC VL D-blade.
| Arm | Type | Receives |
|---|---|---|
| Group C-MAC VS | Active comparator | Device: C-MAC VSpatients undergoing tracheal intubation using the C-MAC VS. |
| Group C-MAC VL D -blade | Placebo comparator | Device: C-MAC VL D -bladepatients undergoing intubation using the C-MAC VL D-blade. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- patients with BMI ≥ 30 kg/m2,
- presence of any predictors of difficult intubation;
- Mallampati score > =3;
- inter-incisor distance < 3 cm;
- thyromental distance < 6 cm;
Key exclusion criteria (2 listed)
- patients have increased risk of pulmonary aspiration;
- have significant medical diseases in term of cardiac, respiratory, hepatic, renal
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 VSpatients undergoing tracheal intubation using the C-MAC VS | Device | Group C-MAC VS |
| C-MAC VL D -bladepatients undergoing intubation using the C-MAC VL D-blade. | Device | Group C-MAC VL D -blade |
Primary outcome
duration of intubation procedure
Time frame: 10 minutes
assess duration of intubation procedure by using C-MAC VS versus C-MAC D-blade in patients with anticipated difficult airway.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2022.
Related trials for Difficult Mask Ventilation
Recruiting
Tulip Airway in Difficult Mask Ventilation (TADMV)
Difficult Mask Ventilation, Airway Devices
Not yet recruitingObservational study
Ultrasound vs Clinical Parameters for Difficult Airway Prediction in Obesity
Obesity (BMI > 35), Difficult Airway
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.
rehab A. Abd Elaziz, Ass.Prof. principal investigator
Alexandria 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 C-MAC VS and C-MAC VL D -blade in people with Difficult Mask Ventilation and Difficult Intubation, run by Alexandria University at 1 site in Egypt.
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 2 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 1 Jun 2022. 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 Egypt. 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. Some participants in this study may receive a placebo. 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?
duration of intubation procedure (time frame: 10 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 1 Jun 2022; AzTrials last refreshed its copy on 30 Oct 2026.