ProVu Video Stylet With Versus Without the Fekry Airway

NCT07568743 | Not Yet Recruiting DMC

• 1 other identifier: IDDS-2026
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief 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 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

Outcome Measures

Primary Outcomes (1)

• 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

  up to 24 weeks

Study Arms (2)

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

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.

Device: ProVu video stylet

Interventions

ProVu video stylet DEVICE

Group C (n=55): Intubation using the ProVu video stylet without the Fekry Airway.

Group F (n =55): endotracheal Intubation assisted by the ProVu video stylet and using Fekry Airway

ProVu video stylet and Fekry Airway DEVICE

Group F (n =55): endotracheal Intubation assisted by the ProVu video stylet and using Fekry Airway

Group C (n=55): Intubation using the ProVu video stylet without the Fekry Airway.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Medicine-Cairo University

Cairo, 11562, Egypt

Location

Study Officials

• Reham Ali Abdelrahman

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Reham Ali Abdelrahman, Assistant Professor, M.D.

CONTACT

01009136408; rehamali72@hotmail.com

Reham Ali Abdelhaleem Abdelrahman, M.D. 00201009136408, M.D.

CONTACT

rehamali72@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesia, Surgical ICU and Pain Management-Faculty of Medicine-Cairo University

Study Record Dates

• First Submitted: April 24, 2026
• First Posted: May 6, 2026
• Study Start (Estimated): May 10, 2026
• Primary Completion (Estimated): September 10, 2026
• Study Completion (Estimated): October 10, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-05

Locations

EG (1)