Intubation; Difficult or FailedNCT07255235
Comparison Between C-mac,Pentax Video Laryngoscopes and Machintosh Laryngoscope
An observational study of Intubation; Difficult or Failed, run by Minia University at 1 site in Egypt.
Trial summary
Asses and compare the practility and the level of difficulty in using C-mac and pentax video-laryngoscopes or the traditional Macintoch laryngoscope in intubation in ICU patients while wearing face shield Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Intubation; Difficult or Failed
- How many people
- 84 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2025to 28 Feb 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients between age 18 - 65 year who will need elective orotracheal intubation will be included in the study after collection of data relevant to intubation except: * Patients with BMI > 35. * Pregnant and lactating patients. * Burn and facial trauma patients. * Suspected or confirmed spine injury. * Presence of any predictors or history of difficult intubation.
Who may be able to join
- All patients between age 18 - 65 year who will need elective orotracheal intubation will be included in the study after collection of data relevant to intubation
Who cannot join
- • Patients with BMI > 35.
- Pregnant and lactating patients.
- Burn and facial trauma patients.
- Suspected or confirmed spine injury.
- Presence of any predictors or history of difficult intubation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Faculty of Medicine Minia University
Ma‘şarat Samālūţ, Minya Governorate, 61511
Dr omyma S Professor and head of department of Anesthesia, +201061762894, mahmoudmai481@gmail.com
Mai M Mohamed Ali
About this study
Official title: Comparative Evaluation of C-Mac, Pentax Video Laryngoscopes, and Macintosh Laryngoscope in Endotracheal Intubation in Intensive Care Unit Wearing a Face Shield.
Asses and compare the practility and the level of difficulty in using C-mac and pentax video-laryngoscopes or the traditional Macintoch laryngoscope in intubation in ICU patients while wearing face shield
Read the detailed description
The endotracheal intubation will be performed with anesthesiologist working in ICU previously trained and experienced in videolaryngoscopy and will be classified according to their skill into 3 groups: Junior (1 year up to 3 year) senior, (3 year up to 8 years) and consultant (more than 8 years) experience. All the laryngoscopist groups will equally attend in performing intubation of the studied group. After the patient consent, the allocation will be opened and preparation for intubation will start. All the intubations will be performed with the presence of two laryngoscopist: one of them at least senior or consultant. After confirmation of well working standard monitoring (ECG, blood pressure, Spo2 and End-tidal CO2) and preoxygenation with 100% oxygen, induction with propofol (1-2 mg/kg) and rocuronium (0.9 mg/kg) will be achieved by an assistant.
While wearing head-fitted face shield, the anesthetist will perform intubation with suitable sized laryngoscopy blade and endotracheal tube. Successful placement of ETT will be confirmed by both auscaltation and capnography (normal appearing waveform over four or more breathing cycles). During endotracheal intubation, anesthesiologists will be permitted to make ergonomic adjustments, such as altering the bed height, position of the patient head and utilize external laryngeal manipulations, equipment adjustment and use of stylet based on their personal preferences. After three failed attempts of intubation, alternative techniques will be used and subsequently, they will not be included in the analysis. Alternative techniques such as gum elastic bougie, laryngeal mask airway (LMA), Cricothyrotomy set will be ready to any unexpected difficult airway. An intubation attempt is defined as introduction of laryngoscope and its subsequent removal with or without endotracheal tube (ETT) placement. Correct placement of ETT in first attempt by an individual laryngoscopist will be defined as first-pass successful intubation.
- Conditions
- Intubation; Difficult or Failed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| C-mac video laryngoscope group | Endotracheal intubation will be performed using the C-Mac video laryngoscope under ICU conditions, while wearing a face shield. The procedure aims to assess time to intubation, ease of use, and success rate. | |
| Pentax video-laryngoscope group | Endotracheal intubation will be performed using the Pentax video laryngoscope under ICU conditions, while wearing a face shield. The procedure aims to assess time to intubation, ease of use, and success rate. | |
| Machintosh laryngoscope group | Endotracheal intubation will be performed using the traditional Macintosh laryngoscope under ICU conditions, while wearing a face shield. The procedure aims to assess time to intubation, ease of use, and success rate. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of first pass of orotracheal intubation
Passage of the orotracheal tube from the first time confirmed By capnography
Measured: Untill the end of the study in average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2025
- Study start1 Dec 2025 (estimated)
- Primary completion30 Jan 2026 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Intubation; Difficult or FailedStudies of the same condition, open and under way.
- More trials run by Minia 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mai Mahmoud Mohamed Ali Mosa, Minia University
- Investigators
- Mai M Mohamed Ali, Principal investigator, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07255235
- Sponsor's protocol ID
- 1463
- Status last verified
- Nov 2025
- First submitted
- 24 Apr 2025
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Taboada M, Almeida X, Carinena A, Costa J, Carmona-Monge J, Agilda A, Barreiro L, Castillo J, Williams K, Segurola J, Alvarez J, Seoane-Pillado T. Complications and degree of difficulty of orotracheal intubation in the Intensive Care Unit before and after the establishment of an intubation protocol for critically ill patients: a prospective, observational study. Rev Esp Anestesiol Reanim (Engl Ed). 2024 Jan;71(1):17-27. doi: 10.1016/j.redare.2023.12.004. Epub 2023 Dec 15.
PubMed 38104962Vig S, Bhan S, Gupta N, Meena JK, Bhatnagar S. Comparison of Mc Grath-MAC and C-MAC video laryngoscopes for intubation in a COVID simulated mannequin by novice users wearing face protective gear: A randomized crossover trial. Saudi J Anaesth. 2021 Apr-Jun;15(2):131-136. doi: 10.4103/sja.sja_1058_20. Epub 2021 Apr 1.
PubMed 34188630
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of C-Mac, Pentax Video Laryngoscopes, and Macintosh Laryngoscope in Endotracheal Intubation in Intensive Care Unit Wearing a Face Shield.
- ClinicalTrials.gov ID
- NCT07255235
- Acronym / sponsor ID
- 1463
- Conditions
- Intubation; Difficult or Failed
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 30 Jan 2026 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 28 Nov 2025 (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.
Asses and compare the practility and the level of difficulty in using C-mac and pentax video-laryngoscopes or the traditional Macintoch laryngoscope in intubation in ICU patients while wearing face shield
Detailed description
The endotracheal intubation will be performed with anesthesiologist working in ICU previously trained and experienced in videolaryngoscopy and will be classified according to their skill into 3 groups: Junior (1 year up to 3 year) senior, (3 year up to 8 years) and consultant (more than 8 years) experience. All the laryngoscopist groups will equally attend in performing intubation of the studied group. After the patient consent, the allocation will be opened and preparation for intubation will start. All the intubations will be performed with the presence of two laryngoscopist: one of them at least senior or consultant. After confirmation of well working standard monitoring (ECG, blood pressure, Spo2 and End-tidal CO2) and preoxygenation with 100% oxygen, induction with propofol (1-2 mg/kg) and rocuronium (0.9 mg/kg) will be achieved by an assistant.
While wearing head-fitted face shield, the anesthetist will perform intubation with suitable sized laryngoscopy blade and endotracheal tube. Successful placement of ETT will be confirmed by both auscaltation and capnography (normal appearing waveform over four or more breathing cycles). During endotracheal intubation, anesthesiologists will be permitted to make ergonomic adjustments, such as altering the bed height, position of the patient head and utilize external laryngeal manipulations, equipment adjustment and use of stylet based on their personal preferences. After three failed attempts of intubation, alternative techniques will be used and subsequently, they will not be included in the analysis. Alternative techniques such as gum elastic bougie, laryngeal mask airway (LMA), Cricothyrotomy set will be ready to any unexpected difficult airway. An intubation attempt is defined as introduction of laryngoscope and its subsequent removal with or without endotracheal tube (ETT) placement. Correct placement of ETT in first attempt by an individual laryngoscopist will be defined as first-pass successful intubation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| C-mac video laryngoscope group | – | –Endotracheal intubation will be performed using the C-Mac video laryngoscope under ICU conditions, while wearing a face shield. The procedure aims to assess time to intubation, ease of use, and success rate. |
| Pentax video-laryngoscope group | – | –Endotracheal intubation will be performed using the Pentax video laryngoscope under ICU conditions, while wearing a face shield. The procedure aims to assess time to intubation, ease of use, and success rate. |
| Machintosh laryngoscope group | – | –Endotracheal intubation will be performed using the traditional Macintosh laryngoscope under ICU conditions, while wearing a face shield. The procedure aims to assess time to intubation, ease of use, and success rate. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients between age 18 - 65 year who will need elective orotracheal intubation will be included in the study after collection of data relevant to intubation except: * Patients with BMI > 35. * Pregnant and lactating patients. * Burn and facial trauma patients. * Suspected or confirmed spine injury. * Presence of any predictors or history of difficult intubation.
Key inclusion criteria (1 listed)
- All patients between age 18 - 65 year who will need elective orotracheal intubation will be included in the study after collection of data relevant to intubation
Key exclusion criteria (5 listed)
- • Patients with BMI > 35.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Success rate of first pass of orotracheal intubation
Time frame: Untill the end of the study in average of 1 year
Passage of the orotracheal tube from the first time confirmed By capnography
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
- Results publication: PubMed 38104962Taboada M, Almeida X, Carinena A, Costa J, Carmona-Monge J, Agilda A, Barreiro L, Castillo J, Williams K, Segurola J, Alvarez J, Seoane-Pillado T. Complications and degree of difficulty of orotracheal intubation in the Intensive Care Unit before and after the establishment of an intubation protocol for critically ill patients: a prospective, observational study. Rev Esp Anestesiol Reanim (Engl Ed). 2024 Jan;71(1):17-27. doi: 10.1016/j.redare.2023.12.004. Epub 2023 Dec 15.
- Results publication: PubMed 34188630Vig S, Bhan S, Gupta N, Meena JK, Bhatnagar S. Comparison of Mc Grath-MAC and C-MAC video laryngoscopes for intubation in a COVID simulated mannequin by novice users wearing face protective gear: A randomized crossover trial. Saudi J Anaesth. 2021 Apr-Jun;15(2):131-136. doi: 10.4103/sja.sja_1058_20. Epub 2021 Apr 1.
- Individual participant dataSharing planned: Undecided
Related trials for Intubation; Difficult or Failed
Not yet recruitingObservational study
Can the "Face Index"; an Anthropometric Measurement, Predict Difficult Laryngoscopy and Intubation?
Anesthesia Intubation Complication, Laryngoscopy
RecruitingObservational study
PrediSuisse: Automatized Assessment of Difficult Airway
Anesthesia, Intubation; Difficult or Failed
RecruitingObservational study
Difficult Airway Prediction by Integrating STOP-BANG Criteria
Ventilatory Defect, Intubation; Difficult or Failed
RecruitingObservational study
Improving Safety and Quality of Tracheal Intubation Practice in Pediatric ICUs
Failed or Difficult Intubation, Sequela, Intubation; Difficult
Active, not recruitingObservational study
Data-driven Development of a Core Dataset for Difficult Airway Alerts
Airway Management, Intubation; Difficult or Failed
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.
Mai M Mohamed Ali principal investigator
Minia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intubation; Difficult or Failed, run by Minia 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 1 inclusion and 5 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: opening soon, as of the sponsor's last update on 5 Dec 2025. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mai M Mohamed Ali Mosa (+201000543376, mahmoudmai481@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate of first pass of orotracheal intubation (time frame: Untill the end of the study in average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07255235, which also lists 2 linked publications.
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 Dec 2025.