NCT07699653 Comparison of Three Airway Intubation Devices for First-Attempt Success in General Anesthesia Patients
| NCT ID | NCT07699653 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Guangzhou University of Chinese Medicine |
| Condition | Airway Management |
| Study Type | INTERVENTIONAL |
| Enrollment | 549 participants |
| Start Date | 2026-07-10 |
| Primary Completion | 2026-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 549 participants in total. It began in 2026-07-10 with a primary completion date of 2026-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Wuhua Ma, MD
PRINCIPAL INVESTIGATOR
The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
Frequently Asked Questions
Who can join the NCT07699653 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Airway Management. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07699653 currently recruiting?
Yes, NCT07699653 is actively recruiting participants. Contact the research team at 15797895330@163.com for enrollment information.
Where is the NCT07699653 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT07699653 clinical trial?
NCT07699653 is sponsored by Guangzhou University of Chinese Medicine. The principal investigator is Wuhua Ma, MD at The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine. The trial plans to enroll 549 participants.