Intubation; Difficult or FailedNCT05094453
Borescope Visually Assisted Intubation Through Fekry Intubating Airway
An observational study of Intubation; Difficult or Failed, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this study is to introduce the borescope visually assisted through Fekry oral Intubating airway as a new means of intubation. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Intubation; Difficult or Failed
- How many people
- 35 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2020to 10 Jul 2021
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study will enroll 35 anesthesia residents in their last year of residency and assistant lecturers in their first year of work who will try to intubate a manikin using the borescope visually assisted through Fekry oral Intubating airway.
Who may be able to join
- Anesthesia residents in the last year of residency.
- Anesthesia assistant lecturers in the first year of work.
Who cannot join
- Assistant lecturers who are in the career for more than one year.
- Paramedical personnels.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Borescope Visually Assisted Intubation Through Fekry Intubating Airway; a Prospective Randomized Controlled Study
The aim of this study is to introduce the borescope visually assisted through Fekry oral Intubating airway as a new means of intubation.
Read the detailed description
Endotracheal intubation is one of the fundamental skills that should be mastered by the anesthesiologist. One of the important causes of anesthesia related mortality and morbidity is difficult airway related events.
A key step in endotracheal intubation is the alignment of the oral, pharyngeal and laryngeal axes. More recently a 2-curve concept has been proposed, involving a primary (oro-pharyngeal curve) and a secondary (pharyngo-glotto-tracheal) curve. The need to align the visual axis to these axes is a common reason for poor visualization of the glottis and the difficulty encountered during endotracheal intubation. Video laryngoscopes (VLS) overcome this problem by allowing the viewer to see the glottis through a camera attached to a curved blade.
Several video laryngoscopes (VLS) are available in the market to facilitate endotracheal intubation. These devices are precluded by their cost and availability especially in developing countries.
Borescope is an instrument that is used to see through a small hole. The endoscope camera diameter is 5.5 mm and the cable is 1 m long with flexible fiber which could be bended as needed. It is illuminated by circumferentially arranged 6 LED lamps on the head of camera. The other end of cable is connected to Android smart phone (Samsung galaxy S5) which supports OTG (on-the-go) function.
Universal Serial Bus (USB) borescopes are commonly used in dental procedures as a dental imaging system.
Borescopes are rugged, waterproof and work on trickle power from USB ports of a laptop, computer or a Smartphone.
The Smartphone provides the power supply and processes the image. The resultant image can be viewed and recorded in any Smartphone by using a variety of free video capture available applications. The auto detect feature of Smartphones allows the image to appear as soon as the USB device is connected, thus requiring minimal time to set up. As the device is waterproof it can be easily sterilized by soap water and glutaraldehyde.
A low-cost VLS ("v-scope") using a straight Miller blade has been tried. The investigators attached an USB borescope to a Miller's blade by waterproof tapes and connected it to a smart phone via an USB-OTG (On the go) cable. Interestingly, it was compared with a conventional Miller blade for intubation and concluded that an ordinary borescope can be used as an effective VLS which is cost effective, easy to assemble and use and can provide acceptable glottis views even in the hands of non-experts.
A similar scope was described, but using a Macintosh blade, in February 2016. The device used the video processing capabilities of a personal computer to display real processing present in the ubiquitous smart phone, keeping the initial and recurring costs of the technique low.
Since economic consideration is very crucial in developing countries, this study is going to test a safe, low cost technique of visually assisted intubation using the Borescope and Fekry airway instead of the high cost offered by different video laryngoscopes (VLS) available in the market.
Fekry airway (Oral Intubating Airway; Egyptian Patent 28118):
Several modifications and versions of oro-pharyngeal airways were introduced into the market to facilitate fiberoptic intubation and easy removal of the airway after placement of ETT.
Fekry airway is a modification of the Williams airway. The modification made to the Williams airway is that the roof of the proximal cylindrical tunnel is removed thus the airway became open anteriorly. This modification offers the following advantages: it allows easy one step insertion of the tube. Also it facilitates the airway removal after ETT insertion without need to remove the international connection of the ETT. Thus Fekry airway can be easily removed from around the tube while it is connected to anesthesia machine (this reduces the risk of inadvertent ETT dislodgement during airway removal).
This study is introducing a novel way to replace the high cost videolaryngoscopy to be used for safe educational purposes and management of difficult airway scenarios.
Our hypothesis is that the borescope in association with Fekry oral airway will introduce a new means for low cost, efficient video assisted endotracheal intubation.
- Conditions
- Intubation; Difficult or Failed
- Keywords
- visually assisted intubation
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the success rate of intubation
To evaluate the success rate of intubation using borescope visually assisted through Fekry airway.
Measured: 1 June 2020 to 1 March 2021
Secondary outcomes (3)
Number of intubation attempts.
Total number of attempts.
Measured: 1 June 2020 to 1 March 2021
Total intubation time
starting from introduction of the borescope/ETT assembly till introducing the tube into the vocal cords reaching the carina
Measured: 1 June 2020 to 1 March 2021
Need of external manipulations to visualize the view.
such as crcoid pressure or laryngeal manipulations
Measured: 1 June 2020 to 1 March 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2021
- Study start1 Jun 2020
- Primary completion1 Mar 2021
- Study completion10 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intubation; Difficult or FailedStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omnia Yahia El Sayed Kamel, Cairo University
- Investigators
- Ashraf Asswa, Professor, Study director, Cairo UniversityMaha Youssef, A.Professor, Study director, Cairo UniversityInas Ali, lecturer, Study director, Cairo UniversitySahar Kassem, lecturer, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05094453
- Sponsor's protocol ID
- Airway management
- Status last verified
- Mar 2022
- First submitted
- 14 Oct 2021
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Borescope Visually Assisted Intubation Through Fekry Intubating Airway; a Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05094453
- Acronym / sponsor ID
- Airway management
- Conditions
- Intubation; Difficult or Failed
- Keywords
- visually assisted intubation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 10 Jul 2021 (actual)
- First posted
- 26 Oct 2021 (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.
The aim of this study is to introduce the borescope visually assisted through Fekry oral Intubating airway as a new means of intubation.
Detailed description
Endotracheal intubation is one of the fundamental skills that should be mastered by the anesthesiologist. One of the important causes of anesthesia related mortality and morbidity is difficult airway related events.
A key step in endotracheal intubation is the alignment of the oral, pharyngeal and laryngeal axes. More recently a 2-curve concept has been proposed, involving a primary (oro-pharyngeal curve) and a secondary (pharyngo-glotto-tracheal) curve. The need to align the visual axis to these axes is a common reason for poor visualization of the glottis and the difficulty encountered during endotracheal intubation. Video laryngoscopes (VLS) overcome this problem by allowing the viewer to see the glottis through a camera attached to a curved blade.
Several video laryngoscopes (VLS) are available in the market to facilitate endotracheal intubation. These devices are precluded by their cost and availability especially in developing countries.
Borescope is an instrument that is used to see through a small hole. The endoscope camera diameter is 5.5 mm and the cable is 1 m long with flexible fiber which could be bended as needed. It is illuminated by circumferentially arranged 6 LED lamps on the head of camera. The other end of cable is connected to Android smart phone (Samsung galaxy S5) which supports OTG (on-the-go) function.
Universal Serial Bus (USB) borescopes are commonly used in dental procedures as a dental imaging system.
Borescopes are rugged, waterproof and work on trickle power from USB ports of a laptop, computer or a Smartphone.
The Smartphone provides the power supply and processes the image. The resultant image can be viewed and recorded in any Smartphone by using a variety of free video capture available applications. The auto detect feature of Smartphones allows the image to appear as soon as the USB device is connected, thus requiring minimal time to set up. As the device is waterproof it can be easily sterilized by soap water and glutaraldehyde.
A low-cost VLS ("v-scope") using a straight Miller blade has been tried. The investigators attached an USB borescope to a Miller's blade by waterproof tapes and connected it to a smart phone via an USB-OTG (On the go) cable. Interestingly, it was compared with a conventional Miller blade for intubation and concluded that an ordinary borescope can be used as an effective VLS which is cost effective, easy to assemble and use and can provide acceptable glottis views even in the hands of non-experts.
A similar scope was described, but using a Macintosh blade, in February 2016. The device used the video processing capabilities of a personal computer to display real processing present in the ubiquitous smart phone, keeping the initial and recurring costs of the technique low.
Since economic consideration is very crucial in developing countries, this study is going to test a safe, low cost technique of visually assisted intubation using the Borescope and Fekry airway instead of the high cost offered by different video laryngoscopes (VLS) available in the market.
Fekry airway (Oral Intubating Airway; Egyptian Patent 28118):
Several modifications and versions of oro-pharyngeal airways were introduced into the market to facilitate fiberoptic intubation and easy removal of the airway after placement of ETT.
Fekry airway is a modification of the Williams airway. The modification made to the Williams airway is that the roof of the proximal cylindrical tunnel is removed thus the airway became open anteriorly. This modification offers the following advantages: it allows easy one step insertion of the tube. Also it facilitates the airway removal after ETT insertion without need to remove the international connection of the ETT. Thus Fekry airway can be easily removed from around the tube while it is connected to anesthesia machine (this reduces the risk of inadvertent ETT dislodgement during airway removal).
This study is introducing a novel way to replace the high cost videolaryngoscopy to be used for safe educational purposes and management of difficult airway scenarios.
Our hypothesis is that the borescope in association with Fekry oral airway will introduce a new means for low cost, efficient video assisted endotracheal intubation.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study will enroll 35 anesthesia residents in their last year of residency and assistant lecturers in their first year of work who will try to intubate a manikin using the borescope visually assisted through Fekry oral Intubating airway.
Key inclusion criteria (2 listed)
- Anesthesia residents in the last year of residency.
- Anesthesia assistant lecturers in the first year of work.
Key exclusion criteria (2 listed)
- Assistant lecturers who are in the career for more than one year.
- Paramedical personnels.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To evaluate the success rate of intubation
Time frame: 1 June 2020 to 1 March 2021
To evaluate the success rate of intubation using borescope visually assisted through Fekry airway.
3 secondary outcomes
Number of intubation attempts.
Time frame: 1 June 2020 to 1 March 2021
Total intubation time
Time frame: 1 June 2020 to 1 March 2021
Need of external manipulations to visualize the view.
Time frame: 1 June 2020 to 1 March 2021
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 6 Apr 2022.
- Individual participant dataSharing planned: No
Related trials for Intubation; Difficult or Failed
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PrediSuisse: Automatized Assessment of Difficult Airway
Anesthesia, Intubation; Difficult or Failed
RecruitingObservational study
Difficult Airway Prediction by Integrating STOP-BANG Criteria
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RecruitingObservational study
Improving Safety and Quality of Tracheal Intubation Practice in Pediatric ICUs
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Active, not recruitingObservational study
Data-driven Development of a Core Dataset for Difficult Airway Alerts
Airway Management, Intubation; Difficult or Failed
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.
Ashraf Asswa, Professor study director
Cairo University
Maha Youssef, A.Professor study director
Cairo University
Inas Ali, lecturer study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intubation; Difficult or Failed, run by Cairo 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 2 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 6 Apr 2022. 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?
To evaluate the success rate of intubation (time frame: 1 June 2020 to 1 March 2021). 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 6 Apr 2022.