A Randomized Controlled SaCo-VLM Trial
NCT07922746, Not applicable, Not yet recruiting, University of Malaya
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | A Randomized Controlled SaCo-VLM Trial | ClinicalTrials.gov |
| NCT number | NCT07922746 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 70 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | University of Malaya | ClinicalTrials.gov |
| Conditions | General Anaesthesia Using Supraglotic Airway | ClinicalTrials.gov |
| Interventions | Video-adjusted SaCoVLM insertion, Conventional blind SaCoVLM insertion | ClinicalTrials.gov |
| First posted | 2026-11-06 | ClinicalTrials.gov |
| Last updated | 2026-11-06 | ClinicalTrials.gov |
Registered outcomes 5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Incidence of Distorted Glottic View Following Head and Neck Repositioning | Intraoperatively, immediately following successful SaCoVLM insertion, during assessment in four standardised head and neck positions (approximately 5-10 minutes after insertion). | 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. | ClinicalTrials.gov |
| Secondary | Oropharyngeal Leak Pressure Across Head and Neck Positions | Intraoperatively, during the four head and neck positioning assessments immediately following successful insertion. | 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. | ClinicalTrials.gov |
| Secondary | Time Required for SaCoVLM Insertion | During initial SaCoVLM insertion under general anaesthesia. | 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. | ClinicalTrials.gov |
| Secondary | Number of SaCoVLM Insertion Attempts | During initial SaCoVLM insertion under general anaesthesia. | 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. | ClinicalTrials.gov |
| Secondary | Anaesthetist-Rated Ease of SaCoVLM Insertion | Immediately following 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. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)