Airway DeviceBASKAvsETTNCT05748782
BASKA Mask in Otologic Surgery in Lateral Position
An observational study of Airway Device, run by Assiut University at 1 site in Egypt.
Trial summary
This study aims to evaluate the Efficiency and safety of BASKA mask ventilation in comparison with endotracheal intubation during otologic surgery performed with the head and neck in the lateral position. The primary outcome will be the intraoperative peak inspiratory pressure (PIP). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Airway Device
- What is being tested?
- Baska Mask and Endotracheal tube
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 23 Jul 2023to 1 Mar 2024
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients Undergoing general anesthesia for ear surgeries in the lateral neck position (60-90 degrees) in whom BASKA mask can be a suitable device for airway management.
Who may be able to join
- Age group 18 - 60 years old.
- Both genders.
- Undergoing general anesthesia for ear surgeries in the lateral neck position (60-90 degrees) in whom BASKA mask can be a suitable device for airway management
Who cannot join
- Patient refusal,
- History of cardiac or respiratory disease, psychological disorders,
- High risk of regurgitation or aspiration based on a history of diabetes, hiatus hernia, gastroesophageal reflux, and obesity,
- neck pathology,
- Predicted difficult airway (history of difficult airway, mouth opening <2.5cm, Modified Mallampati class III/IV, thyro-mental distance <6.5cm or cervical spine pathology),
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Main Assiut University Hospital
Asyut, Assiut Governorate, 71515
Ahmed G Esmael, MBBCH, 01143187593 ext. +20, drahmedgamal127@gmail.com
Hala S Abdel-Ghaffar, MD, 01003812011 ext. +20, hallasaad@yahoo.com
About this study
Official title: Efficiency and Safety of BASKA Mask Ventilation in Comparison With Endotracheal Intubation During Otologic Surgery in the Lateral Head and Neck Position
This study aims to evaluate the Efficiency and safety of BASKA mask ventilation in comparison with endotracheal intubation during otologic surgery performed with the head and neck in the lateral position. The primary outcome will be the intraoperative peak inspiratory pressure (PIP). Secondary outcomes will be intraoperative lung mechanics, oropharyngeal leak pressure (OLP), ventilation score, fiberoptic glottic view score, and perioperative adverse effects.
Read the detailed description
The laryngeal mask airway (LMA) was invented in 1981 by Dr Brain Because of its advantages, LMAs are increasingly used as a substitute for endotracheal tubes in a variety of surgical situations requiring general anesthesia. With the appearance of various new LMAs that address the limitations of the classic model, not only has their use in selective operations increased, but the indications for LMA have also grown LMAs can be inserted into the hypopharynx easily without laryngoscopy and neuromuscular blocking agents, and they can also be removed from the patient's mouth quickly. Decreasing airway irritation during surgery results in fewer hemodynamic changes and airway accidents from anesthesia and enables wakeup with less coughing and bucking, which could result in less ossicular replacement prosthesis displacement .
In middle ear/mastoid procedures, because the operation involves the temporal bone, including the surrounding normal nerves and blood vessels, improper manipulation can lead to complications such as facial paralysis; therefore, the operation needs to be performed carefully. Compared to endotracheal intubation, LMAs have little effect on middle ear pressure . These advantages make anesthesiologists prefer LMAs during otologic surgery. In addition, since LMAs can reduce the response to upper airway stimulation, they can be used as an airway device during surgery requiring facial nerve monitoring without the use of muscle relaxants .
However, the points of contention and primary disadvantages of the use of LMA are the reduced levels of airway protection, the increased risk of gastric insufflation, the difficulty of insertion, partial upper airway obstruction and the possibility of dislocation during the procedure . To expose the operative field, otologists usually require the patient's head be rotated 60°~90° to the healthy side. Some studies have reported that the head and neck position can affect the sealing and ventilation functions of LMAs and the fiberoptic view .
The Baska mask (Logikal Health Products PTY Ltd., Morisset, NSW, Australia) is a supraglottic airway device introduced in 2012 with many innovations that might be expected to overcome these derangements . First, its' non-inflatable cuff is continuous with the central channel of the device and automatically inflates during positive pressure ventilation in response to the increased inflation pressure. This inflation produces an oropharyngeal leak pressure higher than that produced by other LMAs, enabling more effective ventilation. Second, it has an esophageal drainage inlet and side channels that comprise an efficient pharyngeal drainage system which facilitates aspiration of gastric contents, thereby reducing the risk of gastric overinflation and pulmonary aspiration. Third, a strong integrated bite-block that acts as a safeguard against obstruction of the Baska mask.
In this study, the hypothesis is that these modifications might enable the Baska mask to become a reasonable and safe alternative to the endotracheal intubation in during otologic surgery performed with the head and neck in the lateral position.
- Conditions
- Airway Device
- Being tested
- Baska Mask, Endotracheal tube
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baska MaskOther
The Baska mask (Logikal Health Products PTY Ltd., Morisset, NSW, Australia) is a supraglottic airway device introduced in 2012 with many innovations that might be expected to overcome these derangements.
Endotracheal tubeDevice
Also called ETT
BASKA Mask
| Study group | Role | What they receive |
|---|---|---|
| BASKA GROUP | the BASKA mask will be inserted, and its size will be chosen according to the manufacturer's weight-based recommendations. Receives: Other: Baska Mask | |
| ETT GROUP | Patients in this group will be anesthetized using an endotracheal tube of appropriate size. Receives: Device: Endotracheal tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome will be the intraoperative peak inspiratory pressure (PIP)
the peak inspiratory pressure will be measured from the panel of the ventilator electronic box (Datex-Ohmeda,Inc 3030 Ohmeda Drive PO Box 7550 )
Measured: Intraoperative
Secondary outcomes (3)
Oropharyngeal leak pressure
The fresh gas flow will be adjusted to 3 l/min, and the electronic APL valve is set automatically at 30 cmH2O, the airway pressure rises until attaining a plateau that is equal to the total leak pressure of the LMA with an upper limit of airway pressures 40 cm H2O. The airway pressure at which an audible leak is detected at the mouth and auscultated by placing the stethoscope over the patient's neck just lateral to the thyroid cartilage will be recorded as the oropharyngeal leak pressure (OLP) .
Measured: Intraoperative
Ventilation Score
The ventilation score which will be scored from 0 to 3 based on three criteria: no leakage with an airway pressure of 15 cm H2O, bilateral chest excursions with a peak inspiratory pressure of 20 cm of H2O, and a square wave capnography, with each item scoring 0 or 1 point.
Measured: Intraoperative
Fiberoptic Glottic Score
position of the device concerning the glottis will be investigated by inserting a fiberoptic laryngoscope (11301BNX, diameter 5.5 mm; length 65 cm; Karl Storz, Tuttlingen, Germany) will be inserted through the mask to evaluate the glottic view. Oxygen will be administered through the suction port throughout the procedure. Fiberoptic images will be graded with Brimacombe score that ranges from one to five; (grade1= only larynx seen, grade 2=larynx and epiglottis posterior surface seen, grade 3=larynx and epiglottis tip of anterior surface seen, 50% visual obstruction of epiglottis to larynx and grade 5, i.e. epiglottis down folded and larynx cannot be seen directly.
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2023
- Study start23 Jul 2023
- Primary completion1 Mar 2024 (estimated)
- Study completion1 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway DeviceStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hala Saad Abdel-Ghaffar, Assiut University
- Investigators
- Hala S Abdel-Ghaffar, MD, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05748782
- Sponsor's protocol ID
- BASKA mask in otologic surgery
- Acronym
- BASKAvsETT
- Status last verified
- Jul 2023
- First submitted
- 19 Feb 2023
- Last updated
- 25 Jul 2023
- 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 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency and Safety of BASKA Mask Ventilation in Comparison With Endotracheal Intubation During Otologic Surgery in the Lateral Head and Neck Position
- ClinicalTrials.gov ID
- NCT05748782
- Acronym / sponsor ID
- BASKAvsETT / BASKA mask in otologic surgery
- Conditions
- Airway Device
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 23 Jul 2023 (actual)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 1 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.
This study aims to evaluate the Efficiency and safety of BASKA mask ventilation in comparison with endotracheal intubation during otologic surgery performed with the head and neck in the lateral position. The primary outcome will be the intraoperative peak inspiratory pressure (PIP). Secondary outcomes will be intraoperative lung mechanics, oropharyngeal leak pressure (OLP), ventilation score, fiberoptic glottic view score, and perioperative adverse effects.
Detailed description
The laryngeal mask airway (LMA) was invented in 1981 by Dr Brain Because of its advantages, LMAs are increasingly used as a substitute for endotracheal tubes in a variety of surgical situations requiring general anesthesia. With the appearance of various new LMAs that address the limitations of the classic model, not only has their use in selective operations increased, but the indications for LMA have also grown LMAs can be inserted into the hypopharynx easily without laryngoscopy and neuromuscular blocking agents, and they can also be removed from the patient's mouth quickly. Decreasing airway irritation during surgery results in fewer hemodynamic changes and airway accidents from anesthesia and enables wakeup with less coughing and bucking, which could result in less ossicular replacement prosthesis displacement .
In middle ear/mastoid procedures, because the operation involves the temporal bone, including the surrounding normal nerves and blood vessels, improper manipulation can lead to complications such as facial paralysis; therefore, the operation needs to be performed carefully. Compared to endotracheal intubation, LMAs have little effect on middle ear pressure . These advantages make anesthesiologists prefer LMAs during otologic surgery. In addition, since LMAs can reduce the response to upper airway stimulation, they can be used as an airway device during surgery requiring facial nerve monitoring without the use of muscle relaxants .
However, the points of contention and primary disadvantages of the use of LMA are the reduced levels of airway protection, the increased risk of gastric insufflation, the difficulty of insertion, partial upper airway obstruction and the possibility of dislocation during the procedure . To expose the operative field, otologists usually require the patient's head be rotated 60°~90° to the healthy side. Some studies have reported that the head and neck position can affect the sealing and ventilation functions of LMAs and the fiberoptic view .
The Baska mask (Logikal Health Products PTY Ltd., Morisset, NSW, Australia) is a supraglottic airway device introduced in 2012 with many innovations that might be expected to overcome these derangements . First, its' non-inflatable cuff is continuous with the central channel of the device and automatically inflates during positive pressure ventilation in response to the increased inflation pressure. This inflation produces an oropharyngeal leak pressure higher than that produced by other LMAs, enabling more effective ventilation. Second, it has an esophageal drainage inlet and side channels that comprise an efficient pharyngeal drainage system which facilitates aspiration of gastric contents, thereby reducing the risk of gastric overinflation and pulmonary aspiration. Third, a strong integrated bite-block that acts as a safeguard against obstruction of the Baska mask.
In this study, the hypothesis is that these modifications might enable the Baska mask to become a reasonable and safe alternative to the endotracheal intubation in during otologic surgery performed with the head and neck in the lateral position.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BASKA GROUP | – | Other: Baska Maskthe BASKA mask will be inserted, and its size will be chosen according to the manufacturer's weight-based recommendations. |
| ETT GROUP | – | Device: Endotracheal tubePatients in this group will be anesthetized using an endotracheal tube of appropriate size. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients Undergoing general anesthesia for ear surgeries in the lateral neck position (60-90 degrees) in whom BASKA mask can be a suitable device for airway management.
Key inclusion criteria (3 listed)
- Age group 18 - 60 years old.
- Both genders.
- Undergoing general anesthesia for ear surgeries in the lateral neck position (60-90 degrees) in whom BASKA mask can be a suitable device for airway management
Key exclusion criteria (5 listed)
- Patient refusal,
- History of cardiac or respiratory disease, psychological disorders,
- High risk of regurgitation or aspiration based on a history of diabetes, hiatus hernia, gastroesophageal reflux, and obesity,
- neck pathology,
- Predicted difficult airway (history of difficult airway, mouth opening <2.5cm, Modified Mallampati class III/IV, thyro-mental distance <6.5cm or cervical spine pathology),
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 |
|---|---|---|
| Baska MaskThe Baska mask (Logikal Health Products PTY Ltd., Morisset, NSW, Australia) is a supraglottic airway device introduced in 2012 with many innovations that might be expected to overcome these derangements. | Other | BASKA GROUP |
| Endotracheal tubeAlso: ETTBASKA Mask | Device | ETT GROUP |
Primary outcome
The primary outcome will be the intraoperative peak inspiratory pressure (PIP)
Time frame: Intraoperative
the peak inspiratory pressure will be measured from the panel of the ventilator electronic box (Datex-Ohmeda,Inc 3030 Ohmeda Drive PO Box 7550 )
3 secondary outcomes
Oropharyngeal leak pressure
Time frame: Intraoperative
Ventilation Score
Time frame: Intraoperative
Fiberoptic Glottic Score
Time frame: Intraoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2023.
- Individual participant dataSharing planned: No
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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.
Hala S Abdel-Ghaffar, MD principal investigator
Assiut 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 Airway Device, run by Assiut 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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 25 Jul 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed G Esmael, MBBCH (01143187593 ext. 02, drahmedgamal127@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome will be the intraoperative peak inspiratory pressure (PIP) (time frame: Intraoperative). 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 25 Jul 2023.