Endotracheal IntubationNCT07568743
ProVu Video Stylet With Versus Without the Fekry Airway
A study testing ProVu video stylet and ProVu video stylet and Fekry Airway in people with Endotracheal Intubation and Video Rigid Stylet, run by Cairo University at 2 sites in Egypt.
Trial summary
This study aimed to compare assisted intubation using the ProVu video stylet device passing through Fekry airway versus intubation without the use of Fekry airway . The investigators hypothesized that endotracheal intubation assisted by ProVu video stylet using the Fekry airway as a conduit for intubation would… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Endotracheal Intubation, Video Rigid Stylet
- What is being tested?
- ProVu video stylet and ProVu video stylet and Fekry Airway
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 2 sitesEgypt
- Study dates
- 10 May 2026to 10 Oct 2026
- Phase
- Interventional
- 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
Who may be able to join
- • American Society of Anesthesiologists (ASA) physical status I, II.
- Patients scheduled for elective surgery requiring general anesthesia and orotracheal intubation of less than 2 hours duration .
- Ganzouri Airway score <3.
Who cannot join
- Patient with Active cardiac condition.
- Patient with airway congenital anomaly.
- Mallampati score III or IV.
- Body mass index (BMI) > 35 kg/m² (obesity).
- Limited cervical spine mobility.
- History of difficult intubation, upper airway surgery, or trauma.
Show all 9Show fewer
- Facial or oropharyngeal deformities.
- Allergy or contraindication to study medications.
- Refusal to participate.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Reham Ali Abdelhaleem Abdelrahman, M.D. 00201009136408, M.D. contact
Egypt2 sites, 2 recruiting
- Not yet recruiting
Faculty of Medicine-Cairo University
Cairo, 11562
Reham Ali Abdelhaleem Abdelrahman, M.D. 00201009136408 Reham Ali Abdelhaleem Abdelrahman, M.D. 00201009136408, M.D., 01009136408, rehamali72@hotmail.com
- Recruiting
Reham Ali Abdelhaleem Abdelrahman
Cairo, 11562
Reham AA Abdelrahman, M.D., 01009136408, rehamali72@hotmail.com
About this study
Official title: Comparison of Intubation Time and Performance Between the ProVu Video Stylet With Versus Without the Fekry Airway in Adults With Normal Airway: A Single-Blinded Randomized Controlled Trial
This study aimed to compare assisted intubation using the ProVu video stylet device passing through Fekry airway versus intubation without the use of Fekry airway .
The investigators hypothesized that endotracheal intubation assisted by ProVu video stylet using the Fekry airway as a conduit for intubation would improve the glottic visualization and the higher first attempt success rate when compared to endotracheal intubation assisted by ProVu video stylet without using the Fekry airway.
- Conditions
- Endotracheal Intubation, Video Rigid Stylet
- Being tested
- ProVu video stylet, ProVu video stylet and Fekry Airway
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProVu video styletDevice
Group C (n=55): Intubation using the ProVu video stylet without the Fekry Airway.
ProVu video stylet and Fekry AirwayDevice
Group F (n =55): endotracheal Intubation assisted by the ProVu video stylet and using Fekry Airway
| Study group | Role | What they receive |
|---|---|---|
| Group C (n=55): Intubation using the ProVu video stylet without the Fekry Airway. | Other | The ProVu™ video stylet's novelty is a manoeuvrable tip controlled by a bidirectional wheel enabling flexion and retroflexion both of the stylet and tracheal tube with a 95° range of movement. It requires a specific tracheal tube where a softer polyvinyl chloride material is utilised in its distal section underneath the cuff enabling the tip to be flexed. Both the tracheal tube and video stylet are single-use and come with a range of high-resolution reusable video displays for a shared view of the airway Receives: Device: ProVu video stylet and Fekry Airway |
| Group F (n =55): endotracheal Intubation assisted by the ProVu video stylet and using Fekry Airway | Other | The ProVu™ video stylet's novelty is a manoeuvrable tip controlled by a bidirectional wheel enabling flexion and retroflexion both of the stylet and tracheal tube with a 95° range of movement. It requires a specific tracheal tube where a softer polyvinyl chloride material is utilised in its distal section underneath the cuff enabling the tip to be flexed. Both the tracheal tube and video stylet are single-use and come with a range of high-resolution reusable video displays for a shared view of the airway Size10 of the FEKRY airway will be selected. Receives: Device: ProVu video stylet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to successful intubation
It is defined as time in seconds elapsing from touching assimply of ProVu video stylet to insisors (C group)or to Fekry Airway ( F group) till connecting the endotracheal tube to ventlatory circuate after removal of assimply
Measured: within 15 minutes preoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start10 May 2026 (estimated)
- Primary completion10 Sep 2026 (estimated)
- Study completion10 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endotracheal IntubationStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reham Ali Abdelhaleem Abdelrahman, Cairo University
- Investigators
- Reham Ali Abdelrahman, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07568743
- Sponsor's protocol ID
- IDDS-2026
- Status last verified
- May 2026
- First submitted
- 24 Apr 2026
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Intubation Time and Performance Between the ProVu Video Stylet With Versus Without the Fekry Airway in Adults With Normal Airway: A Single-Blinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07568743
- Acronym / sponsor ID
- IDDS-2026
- Conditions
- Endotracheal Intubation, Video Rigid Stylet
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 May 2026 (estimated)
- Primary completion
- 10 Sep 2026 (estimated)
- Study completion
- 10 Oct 2026 (estimated)
- First posted
- 6 May 2026 (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.
This study aimed to compare assisted intubation using the ProVu video stylet device passing through Fekry airway versus intubation without the use of Fekry airway .
The investigators hypothesized that endotracheal intubation assisted by ProVu video stylet using the Fekry airway as a conduit for intubation would improve the glottic visualization and the higher first attempt success rate when compared to endotracheal intubation assisted by ProVu video stylet without using the Fekry airway.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group C (n=55): Intubation using the ProVu video stylet without the Fekry Airway. | Other | Device: ProVu video stylet and Fekry AirwayThe ProVu™ video stylet's novelty is a manoeuvrable tip controlled by a bidirectional wheel enabling flexion and retroflexion both of the stylet and tracheal tube with a 95° range of movement. It requires a specific tracheal tube where a softer polyvinyl chloride material is utilised in its distal section underneath the cuff enabling the tip to be flexed. Both the tracheal tube and video stylet are single-use and come with a range of high-resolution reusable video displays for a shared view of the airway |
| Group F (n =55): endotracheal Intubation assisted by the ProVu video stylet and using Fekry Airway | Other | Device: ProVu video styletThe ProVu™ video stylet's novelty is a manoeuvrable tip controlled by a bidirectional wheel enabling flexion and retroflexion both of the stylet and tracheal tube with a 95° range of movement. It requires a specific tracheal tube where a softer polyvinyl chloride material is utilised in its distal section underneath the cuff enabling the tip to be flexed. Both the tracheal tube and video stylet are single-use and come with a range of high-resolution reusable video displays for a shared view of the airway Size10 of the FEKRY airway will be selected. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- • American Society of Anesthesiologists (ASA) physical status I, II.
Key exclusion criteria (9 listed)
- Patient with Active cardiac condition.
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 |
|---|---|---|
| ProVu video styletGroup C (n=55): Intubation using the ProVu video stylet without the Fekry Airway. | Device | Group F (n =55): endotracheal Intubation assisted by the ProVu video stylet and using Fekry Airway |
| ProVu video stylet and Fekry AirwayGroup F (n =55): endotracheal Intubation assisted by the ProVu video stylet and using Fekry Airway | Device | Group C (n=55): Intubation using the ProVu video stylet without the Fekry Airway. |
Primary outcome
Time to successful intubation
Time frame: within 15 minutes preoperatively
It is defined as time in seconds elapsing from touching assimply of ProVu video stylet to insisors (C group)or to Fekry Airway ( F group) till connecting the endotracheal tube to ventlatory circuate after removal of assimply
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 8 May 2026.
- Individual participant dataSharing planned: Undecided
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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.
Reham Ali Abdelhaleem Abdelrahman, M.D. 00201009136408, M.D. contact
Reham Ali Abdelrahman principal investigator
Cairo University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ProVu video stylet and ProVu video stylet and Fekry Airway in people with Endotracheal Intubation and Video Rigid Stylet, run by Cairo University at 2 sites 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 3 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Reham Ali Abdelrahman, Assistant Professor, M.D. (01009136408, rehamali72@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to successful intubation (time frame: within 15 minutes preoperatively). 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 8 May 2026.