Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| K-2025-214 | Other Identifier | Ethics Committee of the First Affiliated Hospital of Guangzhou University of Chinese Medicine |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
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.
Tracheal intubation is an essential procedure for airway management during general anesthesia. Several visualized intubation devices are used in clinical practice, but each has different advantages and limitations in visualization, maneuverability, and ease of endotracheal tube placement. The SPHJ-II is a novel video-assisted adjustable red-light fluoroscopic tracheal intubation scope designed to improve visualization and facilitate intubation.
This study is a prospective, randomized, single-center, single-blind, parallel-group clinical trial designed to compare the clinical performance of the SPHJ-II, a visual lighted stylet, and a visual intubation fiberscope in adult patients undergoing general anesthesia requiring tracheal intubation. Participants will be randomly assigned in a 1:1:1 ratio to one of the three device groups. All tracheal intubations will be performed by experienced anesthesiologists using standardized operating procedures. The study is designed to evaluate whether the SPHJ-II provides advantages in first-attempt intubation success and procedural performance compared with the other two commonly used visualized intubation devices.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SPHJ-II group | Experimental | Participants randomized to this arm will undergo tracheal intubation using the SPHJ-II visual adjustable red-light tracheal intubation device after induction of general anesthesia. |
|
| Video lighted stylet group | Active Comparator | Participants randomized to this arm will undergo tracheal intubation using a video lighted stylet after induction of general anesthesia. |
|
| Visual intubation fiberscope group | Active Comparator | Participants randomized to this arm will undergo tracheal intubation using a visual intubation fiberscope after induction of general anesthesia. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPHJ-II | Device | The SPHJ-II is a visual adjustable red-light tracheal intubation device used to facilitate endotracheal intubation after induction of general anesthesia. |
|
| Measure | Description | Time Frame |
|---|---|---|
| First-attempt intubation success rate | 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. | During the intubation procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Intubation time | Intubation time is defined as the time from first insertion of the assigned intubation device into the oral cavity until successful tracheal intubation is confirmed by at least 3 consecutive end-tidal carbon dioxide waveforms. | During the intubation procedure |
| Number of intubation attempts |
Not provided
Inclusion Criteria:
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:
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.
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiacheng Fu | Contact | +86 19195352749 | 15797895330@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Wuhua Ma, MD | The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Guangzhou University of Chinese Medicine | Guangzhou | Guangdong | China |
Individual participant data will not be shared because the study involves patient-level clinical data and no formal data-sharing plan has been established.
Not provided
Not provided
Not provided
Not provided
Not provided
This is a prospective, randomized, three-arm parallel-group clinical trial. Eligible patients undergoing general anesthesia with endotracheal intubation will be assigned in a 1:1:1 ratio to intubation with the SPHJ-II visual adjustable red-light intubation device, a video lighted stylet, or a visual intubation fiberscope. Each participant will receive only one assigned intervention, and outcomes will be compared across the three groups.
Not provided
Not provided
Participants are anesthetized during the intervention and are not informed of the assigned intubation device. The anesthesiologist performing tracheal intubation is not blinded because knowledge of the assigned device is necessary for the procedure. Postoperative follow-up personnel and outcome assessors responsible for data collection will remain blinded to treatment allocation whenever feasible.
| Video lighted stylet | Device | A video lighted stylet used to facilitate endotracheal intubation after induction of general anesthesia. |
|
| Visual intubation fiberscope | Device | A visual intubation fiberscope used to facilitate endotracheal intubation after induction of general anesthesia. |
|
Total number of attempts required to achieve successful tracheal intubation. |
| During the intubation procedure |
| Incidence of hypoxemia | Occurrence of oxygen desaturation during tracheal intubation according to the study safety criteria. | During the intubation procedure |
| Incidence of airway-related complications | Occurrence of airway-related complications during or immediately after intubation, including oral or pharyngeal mucosal injury, bleeding, and dental injury. | During and immediately after the intubation procedure |
| Peri-intubation heart rate | Heart rate (HR) measured at predefined peri-intubation time points: baseline after approximately 10 minutes in the operating room before induction (T0), 2 minutes before intubation after induction (T1), within 1 minute after successful tracheal intubation (T2), and 2 minutes after successful tracheal intubation (T3). | From baseline before induction to 2 minutes after successful tracheal intubation |
| Peri-intubation oxygen saturation | Peripheral oxygen saturation (SpO₂) measured at predefined peri-intubation time points: baseline after approximately 10 minutes in the operating room before induction (T0), 2 minutes before intubation after induction (T1), within 1 minute after successful tracheal intubation (T2), and 2 minutes after successful tracheal intubation (T3). | From baseline before induction to 2 minutes after successful tracheal intubation |
| Peri-intubation systolic blood pressure | Systolic blood pressure (SBP) measured at predefined peri-intubation time points: baseline after approximately 10 minutes in the operating room before induction (T0), 2 minutes before intubation after induction (T1), within 1 minute after successful tracheal intubation (T2), and 2 minutes after successful tracheal intubation (T3). | From baseline before induction to 2 minutes after successful tracheal intubation |
| Peri-intubation diastolic blood pressure | Diastolic blood pressure (DBP) measured at predefined peri-intubation time points: baseline after approximately 10 minutes in the operating room before induction (T0), 2 minutes before intubation after induction (T1), within 1 minute after successful tracheal intubation (T2), and 2 minutes after successful tracheal intubation (T3). | From baseline before induction to 2 minutes after successful tracheal intubation |