Single Lung VentilationNCT04757558
C-MAC Video-stylet for Double- Lumen Tracheal Intubation
A study testing C-MAC video-stylet and Macintosh laryngoscope in people with Single Lung Ventilation and Thoracic Anesthesia, run by Alexandria University at 1 site in Egypt.
Trial summary
C-MAC Video Stylet secures the airway. It is a completely new type of video endoscope, it combines the advantages of both rigid and flexible intubation endoscopes. Video allows everyone involved in the intubation to visualize the anatomy simultaneously which facilitates communication and teamwork. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Single Lung Ventilation, Thoracic Anesthesia
- What is being tested?
- C-MAC video-stylet and Macintosh laryngoscope
- 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 Dec 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
- aged 18-60 years,
- of both sex
- of American Society of Anesthesiologists (ASA) physical Status II and III
- undergoing elective intra-thoracic surgeries requiring double lumen intubation. BMI -< 35 kg/m2,
- with Mallampati score of 1 or 2
Who cannot join
- 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
- r difficult mask ventilation; - severe pulmonary ventilation dysfunction
- risk of pulmonary aspiration.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: C-MAC Video-stylet for Double- Lumen Tracheal Intubation: a Prospective Randomized Study
C-MAC Video Stylet secures the airway. It is a completely new type of video endoscope, it combines the advantages of both rigid and flexible intubation endoscopes. Video allows everyone involved in the intubation to visualize the anatomy simultaneously which facilitates communication and teamwork.
Read the detailed description
It can be connected easily to the same C- MAC monitor and Pocket Monitor without requiring any additional light source and camera. Video allows everyone involved in the intubation to visualize the anatomy simultaneously which facilitates communication and teamwork. The device has no lumens so it's very easy to clean. Basically if you can get a tube between the cheek and teeth you can intubate the patient.
- Conditions
- Single Lung Ventilation, Thoracic Anesthesia
- Being tested
- C-MAC video-stylet, Macintosh laryngoscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C-MAC video-styletDevice
Patients will be randomly assigned two group 40 patients each, C-MAC-VS group (VS group) (Karl Storz GmbHand Co.KG, Germany), and control group (C group). This will be done using a closed envelope technique using a computer-generated block randomization method.
Macintosh laryngoscopeDevice
Patients will be randomly assigned two group 40 patients each, C-MAC-VS group (VS group) (Karl Storz GmbHand Co.KG, Germany), and control group (C group). This will be done using a closed envelope technique using a computer-generated block randomization method.
| Study group | Role | What they receive |
|---|---|---|
| C-MAC-VS group | Active comparator | C-MAC-VS will be used to facilitate intubation Receives: Device: C-MAC video-stylet |
| control group | Placebo comparator | direct laryngoscopy using Macintosh laryngoscope will be done for DLT insertion. Receives: Device: Macintosh laryngoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
the time taken for intubation (TTI) by C-MAC-VS
timing for intubation
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2021
- Study start20 Dec 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 Single Lung VentilationStudies of the same condition, open and under way.
- More trials run by Alexandria 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 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
- NCT04757558
- Sponsor's protocol ID
- 0304793
- Status last verified
- Feb 2021
- First submitted
- 13 Feb 2021
- Last updated
- 17 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 17 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- C-MAC Video-stylet for Double- Lumen Tracheal Intubation: a Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT04757558
- Acronym / sponsor ID
- 0304793
- Conditions
- Single Lung Ventilation, Thoracic Anesthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 20 Dec 2020 (actual)
- Primary completion
- 20 May 2021 (estimated)
- Study completion
- 1 Jun 2021 (estimated)
- First posted
- 17 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 secures the airway. It is a completely new type of video endoscope, it combines the advantages of both rigid and flexible intubation endoscopes. Video allows everyone involved in the intubation to visualize the anatomy simultaneously which facilitates communication and teamwork.
Detailed description
It can be connected easily to the same C- MAC monitor and Pocket Monitor without requiring any additional light source and camera. Video allows everyone involved in the intubation to visualize the anatomy simultaneously which facilitates communication and teamwork. The device has no lumens so it's very easy to clean. Basically if you can get a tube between the cheek and teeth you can intubate the patient.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| C-MAC-VS group | Active comparator | Device: C-MAC video-styletC-MAC-VS will be used to facilitate intubation |
| control group | Placebo comparator | Device: Macintosh laryngoscopedirect laryngoscopy using Macintosh laryngoscope will be done for DLT insertion. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- aged 18-60 years,
- of both sex
- of American Society of Anesthesiologists (ASA) physical Status II and III
- undergoing elective intra-thoracic surgeries requiring double lumen intubation. BMI -< 35 kg/m2,
- with Mallampati score of 1 or 2
Key exclusion criteria (8 listed)
- Mallampati score > =3;
- inter-incisor distance < 3 cm;
- thyromental distance < 6 cm;
- neck extension < 80°from neck flexion;
- cervical spine instability;
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 video-styletPatients will be randomly assigned two group 40 patients each, C-MAC-VS group (VS group) (Karl Storz GmbHand Co.KG, Germany), and control group (C group). This will be done using a closed envelope technique using a computer-generated block randomization method. | Device | C-MAC-VS group |
| Macintosh laryngoscopePatients will be randomly assigned two group 40 patients each, C-MAC-VS group (VS group) (Karl Storz GmbHand Co.KG, Germany), and control group (C group). This will be done using a closed envelope technique using a computer-generated block randomization method. | Device | control group |
Primary outcome
the time taken for intubation (TTI) by C-MAC-VS
Time frame: 5 minutes
timing for intubation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2021.
Related trials for Single Lung Ventilation
Recruiting
Hyperangulated vs Standard Videolaryngoscopy vs Direct Laryngoscopy for Double-Lumen Endobronchial Tube Intubation
Endobronchial Intubation, Double Lumen Tube Intubation
Not yet recruiting
The OXY-VENT Study
Cardiac Arrest (CA), Cardiopulmonary Resuscitation (CPR)
Not yet recruiting
Flow-Controlled Ventilation to Improve Postoperative Pulmonary Outcome After Thoracic Surgery
Mechanical Ventilation, Postoperative Pulmonary Complications (PPCs)
RecruitingObservational study
Association of Inspiratory Effort With Dyspnea During Assisted Mechanical Ventilation in Critically Ill Patients
Dyspnea During Mechanical Ventilation, Inspiratory Effort
Not yet recruitingObservational study
Effect of Automated Oxygen Control on Early-childhood Lung Mechanics
Prematurity, Respiratory Distress Neonatal
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 video-stylet and Macintosh laryngoscope in people with Single Lung Ventilation and Thoracic Anesthesia, 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 5 inclusion and 8 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 17 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 taken for intubation (TTI) by C-MAC-VS (time frame: 5 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 17 Feb 2021.