Clinical trial NCT05624073: Blind Tracheal Intubation Through Supraglottic Airway Devices
Official title: Comparison of Blind Tracheal Intubation Through the Air-QTM Blocker and the LarySealTM Pro Laryngeal Mask Airways in Anesthetized Paralyzed Adult Patients Undergoing Elective Ophthalmic Operations
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Respiration and the Airways With Laryngeal Masks
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-11-21
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Eligible subjects of both sexes will be consecutively enrolled and randomly allocated to LarysealTM Pro group or Air-QTM Blocker group through an online randomization program (http://www.randomizer.org) with an allocation ratio of 1:1.

GL (n=35): Laryseal TM Pro will be used as a conduit for blind endotracheal intubation.

GA (n=35): Air-Q Blocker TM will be used as a conduit for blind endotracheal intubation.

Brief summary: Tracheal intubation is considered the gold standard for protecting the airway. As the supraglottic airway devices (SADs) could be inserted without laryngoscopy, so that SADs with different designs and safety issues could be used to manage difficult airways in anesthesia and emergency medicine with continuous patient oxygenation \&ventilation, less hemodynamic stress response and less postoperative complications. These advantages encourage the use of a proper SAD as a conduit for endotracheal intubation in stressful conditions. This study will be carried out to compare the Air-QTM Blocker and LarysealTM Pro for blind tracheal intubation during elective ophthalmic surgeries under general anesthesia. Intubation through SAD can be performed using a fiber-optic bronchoscope or blindly. Blind intubation is meaning that the tube is inserted through SAD without direct visualization of the airway. Success rate of blind intubation ranges between 15% and 97%, mostly depending on the type of used SAD, patient characteristics and operator skills. The availability of blind intubation through SAD is important in cases of difficult intubation (either anticipated or unanticipated) especially if fiber-optic is not available, so that SAD will be convenient for untrained personnel.

Detailed description: The laryseal pro could provide rapid and secure airway management and improve patient safety with gastric access reducing the risk of pulmonary aspiration, in addition to speeding up the ETT tube placement with a unique guide system, beside to integrated fenestrated flap that protects from blockage with minimal increase in flow resistance, and elevates the epiglottis for easy, trauma-free ETT tube or bronchoscope insertion. According to the manufacturer: all these features of laryseal pro allow quick easy first time insertion success. As, the laryseal pro is being of shorter breathing tube and smaller cuff in comparison to Air-Q Blocker, so the laryseal pro is expecting to be more amazing than the Air-Q Blocker especially for the new trainers regarding the total insertion time of the endotracheal tube and success rate. Jatin et al. 2021reported that Air-Q Intubating Laryngeal Airway resulted in significantly more success rate and ease of intubation as compared to Ambu Aura Gain. Andrzej et al. 2018 stated that success rate of blind intubation through Air-Q was 75% when compared to 80% in I-gel group. In contrary, there are limited studies available in literature on blind tracheal intubation through the laryseal pro.

Eligibility criteria: Inclusion Criteria:

1. Age: 18-55 years old.
2. ASA I\&II.
3. Both sexes.
4. El-Ganzouri Airway Score \< or =2

Exclusion Criteria:

1. History of upper respiratory tract infections.
2. History of obstructive sleep apnea (OSA) or STOP Bang-Score \> 4.
3. Potentially full stomach (trauma, morbid obesity BMI\> 35 Kg/m2, pregnancy, history of gastric regurgitation and heart burn).
4. Esophageal reflux (hiatus hernia).
5. Coagulation disorders.

Primary outcomes:
measure: Total insertion time (seconds)
timeFrame: 200 seconds
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Department of Anesthesia, Surgical ICU, and Pain Management
city: Cairo
country: Egypt
facility: Reham Ali Abdelhaleem Abdelrahman
Study officials:
affiliation: Cairo University
name: Reham Ali Abdelhaleem Abdelrahman, M.D.
role: PRINCIPAL_INVESTIGATOR
References: