Blind Tracheal Intubation Through Supraglottic Airway Devices

Recruiting

• Conditions: Respiration and the Airways With Laryngeal Masks
• Interventions: Device: Air-QTM Blocker; Device: LarySealTM Pro

• Registration Number: NCT05624073
• Lead Sponsor: Cairo University

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.

Study Timeline

• Study First Submitted: 2022-11-13
• Study First Submitted QC: 2022-11-13
• Study First Posted: 2022-11-21
• Study Start: 2022-12-17
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-11
• Last Update Posted: 2023-02-14
• Primary Completion: 2023-11-01
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
LarySealTM Pro Laryngeal Mask	Air-QTM Blocker	GL (n=35): Laryseal TM Pro will be used as a conduit for blind endotracheal intubation.
Air-QTM Blocker	LarySealTM Pro	GA (n=35): Air-Q Blocker TM will be used as a conduit for blind endotracheal intubation.

Primary Outcome Measures

Name	Time	Method
Total insertion time (seconds)	200 seconds	Total insertion time (seconds): insertion time (seconds) of the SAD is the time needed for correct SAD placement \&started when SAD touched teeth to the first recorded rectangular capnogram curve with satisfactory bilateral chest expansion + insertion time of the endotracheal tube through the SAD (seconds) is the time in seconds from insertion of the endotracheal tube blindly until capnographic confirmation.

Trial Locations

Locations (2)

Department of Anesthesia, Surgical ICU, and Pain Management; 🇪🇬 Cairo, Egypt

Reham Ali Abdelhaleem Abdelrahman; 🇪🇬 Cairo, Egypt