NCT05751590

Brief Summary

In spite of the development of a lot of airway devices in the past 2 decades, tracheal intubation problems were the most common primary airway problems. The GlideScope® Video Laryngoscope (Verathon, Bothell, WA) is a video laryngoscopy system with a two-segment blade, the distal portion of which houses a charge-coupled device that contains a micro-video camera that transmits images to a 7-inch video liquid crystal display (LCD) monitor. The GlideScope® can be used for routine intubation but is also commonly used as an alternative device for difficult or failed airways. It is particularly useful in cases where cervical motion or mouth opening is limited, preventing creation of a "straight line" of sight from the operator to the glottis . GlideScope improves the laryngeal view as one of its advantages due to the blade angle of 60° which is designed to improve the glottic view without the need of alignment of the oral, pharyngeal, and tracheal axes and also without adding additional lifting force. Fibreoptic intubation with a flexible bronchoscope is an important airway management skill in which anaesthesiologists should be proficient. Unfortunately, clinical experience shows that even with reasonable experience and practice, fibreoptic intubation can be challenging. It requires a high degree of manual dexterity, an ability to manoeuvre quickly under stressful clinical situations, and rigorous training and practice to maintain a high level of skill. Thus, whereas fibreoptic intubatThus, whereas fibreoptic intubation can be used rapidly for intubation, video laryngoscopy may be an effective alternative, especially in patients with an anticipated difficult airway. However, it remains unclear whether video-assisted airway management using the GlideScope provides significant advantages over flexible bronchoscopy in patients with potentially difficult airways , Video laryngoscopy is increasingly used for difficult airway management in anaesthesia, intensive care units and emergency departments. Recently, video laryngoscopy has been incorporated into various difficult airway management algorithms, being recommended as one of the initial steps in the management of difficult airways .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 21, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 2, 2023

Completed
8 days until next milestone

Study Start

First participant enrolled

March 10, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2024

Completed
Last Updated

July 30, 2024

Status Verified

July 1, 2024

Enrollment Period

1.3 years

First QC Date

February 21, 2023

Last Update Submit

July 29, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Endotracheal intubation

    Intubation time is defined as the time from insertion of either the GlideScope combined with the Fiberoptic broncscopy or the Fiberoptic broncscopy alone into the mouth, to the time when end tidal CO2 exceeded (20 mmHg)

    1st seconds till succesfull intubation

Study Arms (2)

Glidescope + Fiberoptic broncscopy

ACTIVE COMPARATOR
Device: comined use of gliddescope and fiberoptic broncscopy

Fiberoptic broncscopy

ACTIVE COMPARATOR
Device: fiberoptic bronscopy

Interventions

endotrachotreal intubation will be done by combined use of Glidescope and Fiberoptic broncscopy

Glidescope + Fiberoptic broncscopy

endotrachotreal intubation will be done by Fiberoptic broncscopy

Fiberoptic broncscopy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients who will be scheduled for elective surgery requiring orotracheal or nasotracheal intubation with anticipated difficult intubation.
  • physical status American Society of Anesthesiologists (ASA) I - III.

You may not qualify if:

  • Patients who refuse to participate
  • patients with body mass index (BMI) \>35 kg/m2
  • coagulopathy, severe thrombocytopenia \<50×103.
  • Pregnant females
  • physical status American Society of Anesthesiologists (ASA)\>IV
  • patients requiring rapid sequence induction
  • patients with closed mouth opening who are candidates only for nasal intubation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University hospitals

Cairo, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

February 21, 2023

First Posted

March 2, 2023

Study Start

March 10, 2023

Primary Completion

June 15, 2024

Study Completion

June 15, 2024

Last Updated

July 30, 2024

Record last verified: 2024-07

Locations