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NCT07922746
A Randomized Controlled SaCo-VLM Trial
Conditions: General Anaesthesia Using Supraglotic Airway
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 70
Sponsor: University of Malaya
Location: Universiti Malaya Medical Centre Kuala Lumpur
Summary
A laryngeal mask airway is a medical device placed through the mouth to help patients breathe during general anaesthesia. It is commonly used during surgery. Usually, anaesthetists insert this device without directly seeing the opening of the airway. They check its position using breathing measurements, chest movements, and signs of air leakage. However, a device may appear to work normally even when it is not positioned correctly. Changes in head and neck position during surgery may also affect its placement.
The SaCo Video Laryngeal Mask Airway (SaCoVLM) is a newer airway device with a built-in camera that allows anaesthetists to see the opening of the airway and adjust the device's position.
The main aim of this study is to find out whether using the built-in camera to guide and adjust the SaCoVLM during insertion results in better airway positioning than the conventional method, which does not use the camera view. The researchers will also investigate whether the airway device remains correctly positioned when the patient's head and neck are moved.
This study will involve 70 adults aged 18 to 65 years who are scheduled for planned surgery under general anaesthesia at Universiti Malaya Medical Centre, Malaysia.
Participants will be randomly assigned to one of two groups, with an equal chance of being placed in either group:
* Group 1 (Video-guided insertion): The anaesthetist will use the SaCoVLM's built-in camera to guide insertion and adjust the device to achieve a better view of the airway opening.
* Group 2 (Conventional blind insertion): The anaesthetist will insert the same device using standard techniques and breathing tests without viewing the camera screen.
After successful insertion, researchers will assess the airway device in four head and neck positions: neutral, turned to the side, tilted backwards, and bent forwards.
The researchers will compare how often the airway opening is partly obscured in each group. They will also measure air leakage around the device, the time and number of attempts needed for insertion, changes in heart rate and blood pressure, and throat-related symptoms after surgery.
All procedures will be performed by experienced anaesthetists under standard monitoring during general anaesthesia. Participants will be assessed for throat-related complications approximately one hour after surgery.
The findings may help determine whether video-guided insertion provides better airway positioning than conventional insertion, particularly during head and neck movement. This information could help improve airway management and patient safety during future surgical procedures.
Eligibility Criteria
Inclusion Criteria :
1. Adults aged 18-65 years.
2. American Society of Anesthesiologists (ASA) physical status I or II.
3. Scheduled for elective non-airway surgery under general anesthesia, with an anticipated surgical duration of 30-180 minutes.
4. Suitable for airway management using a supraglottic airway device (SAD).
5. Body mass index (BMI) between 18.5 and 35 kg/m².
6. Able and willing to provide written informed consent.
Exclusion Criteria :
1. Known or anticipated difficult airway, including Mallampati class III-IV, interincisor distance less than 2.5 cm, or reduced neck mobility.
2. Increased risk of pulmonary aspiration, including inadequate fasting, symptomatic gastroesophageal reflux disease, hiatal hernia, full stomach, or emergency surgery.
3. Known pharyngeal, laryngeal, or upper airway pathology or mass.
4. Cervical spine instability, injury, or previous surgery that prevents safe neck rotation, extension, or flexion.
5. Pregnancy.
6. Surgery requiring prone positioning.
7. Refusal to participate or inability to provide informed consent.
Source: ClinicalTrials.gov (NCT07922746). StuddyBuddy aggregates publicly available trial information.