- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07568743
ProVu Video Stylet With Versus Without the Fekry Airway
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Reham Ali Abdelrahman, Assistant Professor, M.D.
- Phone Number: 01009136408
- Email: rehamali72@hotmail.com
Study Contact Backup
- Name: Reham Ali Abdelhaleem Abdelrahman, M.D. 00201009136408, M.D.
- Email: rehamali72@hotmail.com
Study Locations
-
-
-
Cairo, Egypt, 11562
- Recruiting
- Reham Ali Abdelhaleem Abdelrahman
-
Contact:
- Reham AA Abdelrahman, M.D.
- Phone Number: 01009136408
- Email: rehamali72@hotmail.com
-
Cairo, Egypt, 11562
- Not yet recruiting
- Faculty of Medicine-Cairo University
-
Contact:
- Reham Ali Abdelhaleem Abdelrahman, M.D. 00201009136408 Reham Ali Abdelhaleem Abdelrahman, M.D. 00201009136408, M.D.
- Phone Number: 01009136408
- Email: rehamali72@hotmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
• 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.
Exclusion Criteria:
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.
- Facial or oropharyngeal deformities.
- Allergy or contraindication to study medications.
- Refusal to participate.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Group C (n=55): Intubation using the ProVu video stylet without the Fekry Airway.
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
|
Group F (n =55): endotracheal Intubation assisted by the ProVu video stylet and using Fekry Airway
|
|
Other: Group F (n =55): endotracheal Intubation assisted by the ProVu video stylet and using Fekry Airway
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.
|
Group C (n=55): Intubation using the ProVu video stylet without the Fekry Airway.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
within 15 minutes preoperatively
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Reham Ali Abdelrahman, Cairo University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- IDDS-2026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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