Which intubation tool works best? trial puts three devices Head-to-Head
NCT ID NCT07699653
First seen Jul 13, 2026 · Last updated Sep 09, 2026 · Updated 2 times
Summary
This trial compares three devices—SPHJ-II, a video lighted stylet, and a visual fiberscope—for placing a breathing tube in adults under general anesthesia. About 549 participants will be randomly assigned to one device to see which gives the highest first-attempt success rate. The study also measures intubation time, number of attempts, and any complications. Results could help guide which tool anesthesiologists use for safer airway management.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- SPHJ-II visual lighted stylet, video lighted stylet, visual intubation fiberscope
- What this could lead to
- If one device proves superior, it could become the preferred tool for safer, faster intubation during general anesthesia.
- What could go wrong
- This is a device comparison study, not a test of a new drug or cure. Results may not apply to all patients or settings, and individual device performance can vary.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 549 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2026
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age 18 to 65 years, inclusive. American Society of Anesthesiologists (ASA) physical status I to III. Scheduled for surgery under general anesthesia requiring endotracheal intubation. The participant or legally authorized representative is fully informed of the purpose, methods, potential risks, and possible benefits of the study and provides written informed consent. Exclusion Criteria: * Anticipated severe difficulty with mask ventilation, such as severe obesity (BMI \> 35 kg/m²) with obstructive sleep apnea syndrome, history of neck radiotherapy, craniofacial malformation, or other conditions judged by the attending anesthesiologist to confer high risk for mask ventilation, and patients requiring awake tracheal intubation. Cervical spine instability, cervical trauma, rheumatoid arthritis involving the cervical spine, ankylosing spondylitis, or any condition requiring absolute cervical immobilization during the procedure. Significant airway involvement identified preoperatively, including imaging evidence of tracheal narrowing with minimal diameter \< 5 mm, severe tracheal compression, displacement or collapse, stridor at rest or after activity, vocal cord paralysis with dyspnea, giant thyroid mass with orthopnea, or other oral, pharyngeal, or laryngeal tumor, edema, stenosis, abscess, or severe upper airway anatomical abnormality affecting glottic exposure or endotracheal tube passage. High risk of reflux and aspiration. Severe cardiovascular disease, severe respiratory disease, severe hepatic or renal dysfunction, severe coagulation disorder, frailty, pregnancy or breastfeeding, or known allergy. Any other condition making the patient unsuitable for participation in the study, such as psychiatric illness, communication disorder, or poor compliance.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The First Affiliated Hospital of Guangzhou University of Chinese Medicine
RECRUITINGGuangzhou, Guangdong, 510405, China
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