An interventional study of Video-adjusted SaCoVLM insertion and Conventional blind SaCoVLM insertion in General Anaesthesia Using Supraglotic Airway, sponsored by University of Malaya. Not yet recruiting at 1 site in Malaysia. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by University of Malaya · Not applicable, Interventional, and Treatment
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:
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.
Background and Rationale
Supraglottic airway devices (SADs), including laryngeal mask airways (LMAs), are widely used for airway management during general anaesthesia. Conventional placement is usually confirmed through indirect assessments, including capnography, bilateral chest movement, absence of audible air leakage, and acceptable oropharyngeal leak pressure (OLP). Although these assessments indicate adequate ventilation and airway seal, they do not directly demonstrate anatomical alignment between the airway device and the glottic opening.
Previous fibreoptic and video-assisted studies have demonstrated that some supraglottic airway devices may be anatomically malpositioned despite meeting conventional placement criteria. Malposition may involve partial obstruction of the airway opening by surrounding structures or misalignment of the device with the glottis. Such abnormalities may remain undetected when ventilation is initially adequate.
Changes in head and neck position during surgery may further influence airway device alignment and performance. Neck rotation, extension, and flexion can alter the relationship between the supraglottic airway device and surrounding anatomical structures, potentially affecting airway seal pressure and ventilation.
The SaCo Video Laryngeal Mask Airway (SaCoVLM) incorporates a built-in camera that enables real-time visualisation of the glottis during and after insertion. This allows the anaesthetist to adjust the device's depth, rotation, or position based on direct visual feedback.
Although previous studies have investigated SaCoVLM placement and visual optimisation, limited evidence is available regarding whether video-adjusted insertion provides more stable anatomical positioning than conventional blind insertion when subsequent head and neck movements occur.
This study is designed to address this knowledge gap by comparing two insertion techniques using the same video-enabled airway device, thereby minimising confounding caused by differences in device design.
Study Design and Methodology
This is a prospective, single-centre, two-arm, parallel-group randomised controlled trial conducted at Universiti Malaya Medical Centre, Kuala Lumpur, Malaysia.
Participants will be randomly allocated in a 1:1 ratio to either video-adjusted insertion or conventional blinded insertion of the SaCoVLM. Randomisation will use a computer-generated sequence with permuted blocks of six. Group allocation will be concealed using sequentially numbered, opaque, sealed envelopes prepared by an independent research team member.
The same SaCoVLM device will be used in both groups. The only intended difference between groups is whether the anaesthetist can use the built-in video display to optimise device positioning during insertion.
In the video-adjusted group, the anaesthetist will view the built-in camera display during insertion and perform gentle positional adjustments to achieve an optimal glottic view.
In the conventional blinded group, the video display will be physically covered from the inserting anaesthetist. Placement will be performed using conventional insertion techniques and confirmed using standard clinical assessments without visual guidance.
All insertions will be performed by anaesthetists with more than five years of anaesthesia experience. Standardised general anaesthesia and intraoperative monitoring will be applied to both groups.
The inserting anaesthetist cannot be blinded because of the nature of the intervention. However, participants, postoperative assessment staff, and the independent assessor responsible for grading recorded glottic views will be blinded to group allocation.
Standardised Head and Neck Positioning
Following successful device insertion and confirmation using conventional placement criteria, each participant will undergo airway assessment in four standardised head and neck positions:
The angles will be standardised using a goniometer.
At each position, the glottic view will be recorded using the SaCoVLM camera, and OLP will be measured to assess the effectiveness of the airway seal.
In the conventional blinded group, the video display will remain concealed from the inserting anaesthetist, while images will be recorded for subsequent independent assessment.
Glottic exposure will be assessed using the four-grade SaCoVLM classification system. Grades 1 and 2 represent distorted or partially obscured views of the glottic opening, while grades 3 and 4 represent satisfactory glottic visualisation.
After completion of the positioning assessments, the participant will be returned to the neutral supine position for maintenance of general anaesthesia.
Clinical Assessments and Safety Monitoring
The study will also examine procedural efficiency, airway seal performance, physiological responses to insertion, and postoperative airway-related symptoms.
Insertion efficiency will be assessed through insertion time, number of attempts, and time required to confirm satisfactory device placement.
Heart rate and mean arterial pressure will be documented around the time of insertion. Participants will undergo postoperative assessment approximately one hour after surgery for airway-related symptoms, including coughing, sore throat, hoarseness, difficulty swallowing, and evidence of minor airway trauma.
All participants will receive standard intraoperative monitoring, including electrocardiography, non-invasive blood pressure measurement, pulse oximetry, capnography, and anaesthetic agent monitoring.
Device cuff pressure will be maintained at or below 60 cmH2O. Any clinically significant airway obstruction, inadequate ventilation, oxygen desaturation, or other airway complication will be managed promptly according to established clinical practice, including conversion to endotracheal intubation when indicated.
An independent Data and Safety Monitoring Board will oversee an interim assessment for safety and futility after approximately 50% of participants have been recruited.
Statistical Analysis
The primary analysis will follow the intention-to-treat principle, with a per-protocol sensitivity analysis.
Because glottic visualisation and OLP are repeatedly assessed within individual participants across different head and neck positions, mixed-effects statistical models will be used to account for correlations between repeated measurements.
The incidence of distorted glottic views will be analysed using a generalised linear mixed-effects model with a binomial distribution and logit link function. Study group, head and neck position, and their interaction will be included as fixed effects, with random intercepts for participants and inserting operators.
The interaction between study group and head and neck position will determine whether changes in glottic visualisation associated with repositioning differ between video-adjusted and conventional insertion techniques.
OLP will be analysed using a linear mixed-effects model with a similar structure.
Other continuous and categorical outcomes will be compared using appropriate parametric or non-parametric statistical tests. Secondary analyses will be considered exploratory.
All analyses will use two-sided statistical testing with a significance threshold of p \< 0.05.
Clinical Significance
This study aims to determine whether real-time video-guided adjustment of a supraglottic airway device provides an anatomical positioning advantage over conventional blind insertion, particularly when the head and neck are subsequently repositioned.
If video-adjusted insertion reduces the occurrence of distorted glottic views, the findings may support the incorporation of direct visual assessment into routine supraglottic airway placement, especially during procedures involving head and neck movement.
Alternatively, if both insertion techniques demonstrate comparable performance, the findings may provide evidence supporting the continued use of conventional insertion and confirmation techniques.
The results are expected to improve understanding of the relationship between anatomical device positioning, airway seal performance, and conventional clinical placement assessments. This may contribute to future research and recommendations concerning airway management during general anaesthesia.
University of Malaya is the lead sponsor of 284 studies on the registry; 58 are open to participants now.
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Exclusion Criteria :
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Video-adjusted SaCoVLM insertion
Device: Conventional blind SaCoVLM insertion
The SaCo Video Laryngeal Mask Airway (SaCoVLM) will be inserted under general anaesthesia using its built-in camera for real-time visual guidance. The anaesthetist will observe the glottic opening and perform gentle adjustments in device depth, rotation, or position to achieve an optimal glottic view (Grade 3 or 4) before securing the device. Successful placement will be confirmed using standard clinical airway performance tests, including capnography, bilateral chest movement, absence of audible air leakage, and oropharyngeal leak pressure (OLP). The device will subsequently be assessed in four standardised head and neck positions: neutral supine, 45° lateral rotation, 45° extension, and 30° flexion.
The SaCo Video Laryngeal Mask Airway (SaCoVLM) will be inserted under general anaesthesia using the conventional blind insertion technique without real-time visual guidance. The device's built-in video monitor will be physically covered from the inserting anaesthetist. Placement will be confirmed using standard clinical airway performance tests, including capnography, bilateral chest movement, absence of audible air leakage, and oropharyngeal leak pressure (OLP). No adjustments will be made based on the video image. The device will subsequently be assessed in four standardised head and neck positions: neutral supine, 45° lateral rotation, 45° extension, and 30° flexion. Video recordings will be collected for independent assessment without revealing the images to the inserting anaesthetist.
Incidence of Distorted Glottic View Following Head and Neck Repositioning
The proportion of participants with a distorted glottic view (SaCoVLM Grade 1 or 2) following head and neck repositioning, despite satisfactory conventional airway placement tests. Glottic views will be assessed using recorded SaCoVLM images in three repositioned states: 45° lateral rotation, 45° neck extension, and 30° neck flexion, with neutral supine position as the reference. The incidence will be compared between video-adjusted and conventional blind insertion groups. Grades 1-2 indicate partial visualisation of the laryngeal inlet, whereas Grades 3-4 indicate satisfactory glottic visualisation.
Time frame: Intraoperatively, immediately following successful SaCoVLM insertion, during assessment in four standardised head and neck positions (approximately 5-10 minutes after insertion).
Oropharyngeal Leak Pressure Across Head and Neck Positions
Oropharyngeal leak pressure (OLP), measured in cmH2O, will be assessed in four standardised head and neck positions: neutral supine, 45° lateral rotation, 45° neck extension, and 30° neck flexion. OLP will be measured using the adjustable pressure-limiting valve technique. Measurements will be compared between the video-adjusted and conventional blind insertion groups to evaluate airway seal performance during repositioning.
Time frame: Intraoperatively, during the four head and neck positioning assessments immediately following successful insertion.
Time Required for SaCoVLM Insertion
Time in seconds required to achieve confirmed SaCoVLM placement. Confirmation is defined as achieving an optimal glottic view in the video-adjusted group or meeting conventional airway placement criteria in the blind insertion group. Insertion times will be compared between groups to evaluate procedural efficiency.
Time frame: During initial SaCoVLM insertion under general anaesthesia.
Number of SaCoVLM Insertion Attempts
Number of attempts required to achieve successful SaCoVLM placement, recorded for each participant. The number of insertion attempts will be compared between the video-adjusted and conventional blind insertion groups to assess insertion efficiency.
Time frame: During initial SaCoVLM insertion under general anaesthesia.
Anaesthetist-Rated Ease of SaCoVLM Insertion
Ease of SaCoVLM insertion will be assessed by the inserting anaesthetist using a numerical rating scale (NRS). Ratings will be compared between the video-adjusted and conventional blind insertion groups to evaluate perceived procedural difficulty.
Time frame: Immediately following SaCoVLM insertion.
Plan to share: No — Individual participant data (IPD) will not be made publicly available or routinely shared with external researchers due to participant confidentiality, data protection considerations, and institutional research governance requirements. All study data will be de-identified, securely stored, and accessible only to authorised research team members. Aggregated, non-identifiable study findings will be disseminated through peer-reviewed publications and scientific conferences.
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