Airway Management, General Anesthesia, Tracheal Intubation
Conditions
Keywords
SPHI-II, Visual lighted stylet, Visual intubation fiberscope, First-attempt intubation success, Randomized controlled trial
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.
Detailed description
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.
Interventions
DEVICESPHJ-II
The SPHJ-II is a visual adjustable red-light tracheal intubation device used to facilitate endotracheal intubation after induction of general anesthesia.
DEVICEVideo lighted stylet
A video lighted stylet used to facilitate endotracheal intubation after induction of general anesthesia.
DEVICEVisual intubation fiberscope
A visual intubation fiberscope used to facilitate endotracheal intubation after induction of general anesthesia.
Sponsors
Guangzhou University of Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intubation time | During the intubation procedure | 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. |
| Number of intubation attempts | During the intubation procedure | Total number of attempts required to achieve successful tracheal intubation. |
| Incidence of hypoxemia | During the intubation procedure | Occurrence of oxygen desaturation during tracheal intubation according to the study safety criteria. |
| Incidence of airway-related complications | During and immediately after the intubation procedure | Occurrence of airway-related complications during or immediately after intubation, including oral or pharyngeal mucosal injury, bleeding, and dental injury. |
| Peri-intubation heart rate | From baseline before induction to 2 minutes after successful tracheal intubation | 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). |
| Peri-intubation oxygen saturation | From baseline before induction to 2 minutes after successful tracheal intubation | 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). |
| Peri-intubation systolic blood pressure | From baseline before induction to 2 minutes after successful tracheal intubation | 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). |
| Peri-intubation diastolic blood pressure | From baseline before induction to 2 minutes after successful tracheal intubation | 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). |
Countries
China
Contacts
CONTACTJiacheng Fu
PRINCIPAL_INVESTIGATORWuhua Ma, MD
The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
Outcome results
None listed