Difficult Mask VentilationNCT04759287
Effectiveness of C-MAC Video-stylet Versus Fiberoptic Bronchoscope for Awake Intubation
A study testing C-MAC VS and flexible fibreoptic bronchoscope in people with Difficult Mask Ventilation and Difficult Intubation, run by rehab zayed at 1 site in Egypt.
Trial summary
C-MAC- Video Stylet is a completely new type of video endoscope. It combines the advantages of both rigid and flexible intubation endoscopes. 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 flexible fibreoptic bronchoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Nov 2020to 1 Jun 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 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 Fiberoptic Bronchoscope for Awake Intubation in Patients With Predicted Difficult Airway
C-MAC- Video Stylet is a completely new type of video endoscope. It combines the advantages of both rigid and flexible intubation endoscopes.
Read the detailed description
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.
- Conditions
- Difficult Mask Ventilation, Difficult Intubation
- Being tested
- C-MAC VS, flexible fibreoptic bronchoscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C-MAC VSDevice
The first group (VS group) will include patients undergoing awake intubation using the C-MAC VS
flexible fibreoptic bronchoscopeDevice
The second control group (FOB group) will include patients undergoing awake intubation using the flexible fibreoptic bronchoscope.
| Study group | Role | What they receive |
|---|---|---|
| VS group | Active comparator | include patients undergoing awake intubation using the C-MAC VS Receives: Device: C-MAC VS |
| FOB group | Placebo comparator | will include patients undergoing awake intubation using the flexible fibreoptic bronchoscope. Receives: Device: flexible fibreoptic bronchoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
the time required for a wake intubation
assess the time required for a wake intubation using C-MAC VS versus FOB 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 start20 Nov 2020
- Primary completion20 May 2021 (estimated)
- Study completion1 Jun 2021 (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. The first group (VS group) will include patients undergoing awake intubation using the C-MAC VS. The second control group (FOB group) will include patients undergoing awake intubation using the flexible fibreoptic bronchoscope.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- rehab zayed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, rehab zayed, Alexandria University
- Investigators
- rehab A. Abd Elaziz, Ass.Prof., Principal investigator, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04759287
- Sponsor's protocol ID
- 0304792
- Status last verified
- Feb 2021
- First submitted
- 15 Feb 2021
- Last updated
- 18 Feb 2021
- 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 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of C-MAC Video-stylet Versus Fiberoptic Bronchoscope for Awake Intubation in Patients With Predicted Difficult Airway
- ClinicalTrials.gov ID
- NCT04759287
- Acronym / sponsor ID
- 0304792
- Conditions
- Difficult Mask Ventilation, Difficult Intubation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- rehab zayedUniversity, hospital or other
- Study start
- 20 Nov 2020 (actual)
- Primary completion
- 20 May 2021 (estimated)
- Study completion
- 1 Jun 2021 (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.
C-MAC- Video Stylet is a completely new type of video endoscope. It combines the advantages of both rigid and flexible intubation endoscopes.
Detailed description
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.
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. The first group (VS group) will include patients undergoing awake intubation using the C-MAC VS. The second control group (FOB group) will include patients undergoing awake intubation using the flexible fibreoptic bronchoscope.
| Arm | Type | Receives |
|---|---|---|
| VS group | Active comparator | Device: C-MAC VSinclude patients undergoing awake intubation using the C-MAC VS |
| FOB group | Placebo comparator | Device: flexible fibreoptic bronchoscopewill include patients undergoing awake intubation using the flexible fibreoptic bronchoscope. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 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 VSThe first group (VS group) will include patients undergoing awake intubation using the C-MAC VS | Device | VS group |
| flexible fibreoptic bronchoscopeThe second control group (FOB group) will include patients undergoing awake intubation using the flexible fibreoptic bronchoscope. | Device | FOB group |
Primary outcome
the time required for a wake intubation
Time frame: 10 minutes
assess the time required for a wake intubation using C-MAC VS versus FOB 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 18 Feb 2021.
Related trials for Difficult Mask Ventilation
Not yet recruitingObservational study
Preoperative Frailty and Suboptimal Mask Ventilation in Cardiac Surgery Patients
Frailty, Suboptimal Mask Ventilation
Not yet recruitingObservational study
Prediction of Difficult Mask Ventilation in Obese Population Undergoing Emergency Surgery
Difficult Airway Management
Recruiting
Tulip Airway in Difficult Mask Ventilation (TADMV)
Difficult Mask Ventilation, Airway Devices
Not yet recruitingObservational study
Perioperative Respiratory Adverse Events in Cleft Lip and Palate Surgery: Incidence, Risk Factors, and Clinical Scoring
Cleft Palate, Cleft Lip
Active, not recruitingObservational study
The Impact of Ultrasound Measurements in Predicting Difficult Airway on Videolaryngoscopy Success
Ultrasonography, 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 flexible fibreoptic bronchoscope in people with Difficult Mask Ventilation and Difficult Intubation, run by rehab zayed 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 8 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 18 Feb 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 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?
the time required for a wake intubation (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 18 Feb 2021.