AnesthesiaNCT05751590
Combined Use of Glidescope With Fiber Optic Broncscopy Versus Fiber Optic Alone in Difficult Intubation
A study testing comined use of gliddescope and fiberoptic broncscopy and fiberoptic bronscopy in people with Anesthesia, run by Ain Shams University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- comined use of gliddescope and fiberoptic broncscopy and fiberoptic bronscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Mar 2023to 15 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Combined Use of Glidescope With Fiber Optic Broncscopy Versus Fiber Optic Alone in Difficult Intubation: a Randomized Clinical Trial
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 .
Read more
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 .
- Conditions
- Anesthesia
- Being tested
- comined use of gliddescope and fiberoptic broncscopy, fiberoptic bronscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
comined use of gliddescope and fiberoptic broncscopyDevice
endotrachotreal intubation will be done by combined use of Glidescope and Fiberoptic broncscopy
fiberoptic bronscopyDevice
endotrachotreal intubation will be done by Fiberoptic broncscopy
| Study group | Role | What they receive |
|---|---|---|
| Glidescope + Fiberoptic broncscopy | Active comparator | Not described Receives: Device: comined use of gliddescope and fiberoptic broncscopy |
| Fiberoptic broncscopy | Active comparator | Not described Receives: Device: fiberoptic bronscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 1st seconds till succesfull intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2023
- Study start10 Mar 2023
- Primary completion15 Jun 2024
- Study completion15 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amin Mohammed Alansary Amin Ahmed Helwa, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05751590
- Sponsor's protocol ID
- FMASU R08/2023
- Status last verified
- Jul 2024
- First submitted
- 21 Feb 2023
- Last updated
- 30 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Use of Glidescope With Fiber Optic Broncscopy Versus Fiber Optic Alone in Difficult Intubation: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05751590
- Acronym / sponsor ID
- FMASU R08/2023
- Conditions
- Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 10 Mar 2023 (actual)
- Primary completion
- 15 Jun 2024 (actual)
- Study completion
- 15 Jun 2024 (actual)
- First posted
- 2 Mar 2023 (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.
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 .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glidescope + Fiberoptic broncscopy | Active comparator | Device: comined use of gliddescope and fiberoptic broncscopy |
| Fiberoptic broncscopy | Active comparator | Device: fiberoptic bronscopy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| comined use of gliddescope and fiberoptic broncscopyendotrachotreal intubation will be done by combined use of Glidescope and Fiberoptic broncscopy | Device | Glidescope + Fiberoptic broncscopy |
| fiberoptic bronscopyendotrachotreal intubation will be done by Fiberoptic broncscopy | Device | Fiberoptic broncscopy |
Primary outcome
Endotracheal intubation
Time frame: 1st seconds till succesfull 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing comined use of gliddescope and fiberoptic broncscopy and fiberoptic bronscopy in people with Anesthesia, run by Ain Shams University at 1 site 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 2 inclusion and 7 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: finished, as of the sponsor's last update on 30 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endotracheal intubation (time frame: 1st seconds till succesfull intubation). 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 30 Jul 2024.