ProVu Video Stylet With Versus Without the Fekry Airway

May 5, 2026 updated by: Reham Ali Abdelhaleem Abdelrahman, Cairo University

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
130

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Reham Ali Abdelrahman, Assistant Professor, M.D.
  • Phone Number: 01009136408
  • Email: rehamali72@hotmail.com

Study Contact Backup

Study Locations

  • Egypt
      • Cairo, Egypt, 11562
        • Recruiting
        • Reham Ali Abdelhaleem Abdelrahman
        • Contact:
      • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Device: ProVu video stylet and Fekry 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.
Device: ProVu video stylet
Group C (n=55): Intubation using the ProVu video stylet without the Fekry Airway.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cairo University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Reham Ali Abdelrahman, Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 10, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 10, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 10, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 24, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 1, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 6, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IDDS-2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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