Recruiting
Not applicable
Comparison of Three Airway Intubation Devices for First-Attempt Success in General Anesthesia Patients
Condition(s) studied
Airway ManagementGeneral AnesthesiaTracheal Intubation
Investigational drug(s) / intervention(s)
SPHJ-IIVideo lighted styletVisual intubation fiberscope
SPHJ-II: The SPHJ-II is a visual adjustable red-light tracheal intubation device used to facilitate endotracheal intubation after induction of general anesthesia.
Video lighted stylet: A video lighted stylet used to facilitate endotracheal intubation after induction of general anesthesia.
Visual intubation fiberscope: A visual intubation fiberscope used to facilitate endotracheal intubation after induction of general anesthesia.
Study summary
The goal of this clinical trial is to compare three airway intubation devices in adult patients undergoing general anesthesia who require tracheal intubation. The main questions it aims to answer are:
* Does the SPHJ-II video-assisted adjustable red-light fluoroscopic tracheal intubation scope improve first-attempt intubation success compared with a visual lighted stylet and a visual intubation fiberscope?
* How do the three devices compare in intubation efficiency, intubation-related complications, and peri-intubation physiological responses?
Researchers will compare the SPHJ-II, the visual lighted stylet, and the visual intubation fiberscope to evaluate their performance during tracheal intubation.
Participants will be randomly assigned to one of the three device groups and undergo tracheal intubation during general anesthesia using the assigned device.
Eligibility
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.
Primary outcome measure(s)
- First-attempt intubation success rate — During the intubation procedure
First-attempt intubation success is defined as successful tracheal intubation using the randomly assigned study device on the first attempt, with successful placement confirmed by the appearance of a sustained and regular end-tidal carbon dioxide waveform within 60 seconds of intubation attempt initiation.
Trial sites (1)
| Facility | City | Region | Status |
|---|
| The First Affiliated Hospital of Guangzhou University of Chinese Medicine |
Guangzhou |
Guangdong |
Recruiting |
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