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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Hala S Abdel-Ghaffar, MD contact

01003812011 ext. 02

hallasaad@yahoo.com

Egypt1 site, 1 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

    Recruiting

Other trials in Egypt

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 groups in NCT05748782
Study groupRoleWhat they receive
BASKA GROUPthe BASKA mask will be inserted, and its size will be chosen according to the manufacturer's weight-based recommendations.
Receives: Other: Baska Mask
ETT GROUPPatients 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.

  1. 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)
  1. 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

  2. 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

  3. 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.

  1. First posted1 Mar 2023
  2. Study start23 Jul 2023
  3. Primary completion1 Mar 2024 (estimated)
  4. Study completion1 Mar 2024 (estimated)

Resources

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)
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

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.

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