Comparison of Three Airway Intubation Devices for First-Attempt Success in General Anesthesia Patients

Application of SPHJ-II, Visual Lighted Stylet, and Visual Intubation Fiberscope in Endotracheal Intubation in Patients Under General Anesthesia

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Airway Management; General Anesthesia; Tracheal Intubation
• Intervention / Treatment: Device: SPHJ-II; Device: Video lighted stylet; Device: Visual intubation fiberscope

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.

• Study Type: Interventional
• Enrollment (Estimated): 549
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jiacheng Fu; Phone Number: +86 19195352749; Email: 15797895330@163.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China
      • The First Affiliated Hospital of Guangzhou University of Chinese Medicine
      • Contact: Jiacheng Fu; Phone Number: +86 19195352749; Email: 15797895330@163.com
      • Principal Investigator: Wuhua Ma, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SPHJ-II group; 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.	Device: SPHJ-II; The SPHJ-II is a visual adjustable red-light tracheal intubation device used to facilitate endotracheal intubation after induction of general anesthesia.
Active Comparator: Video lighted stylet group; Participants randomized to this arm will undergo tracheal intubation using a video lighted stylet after induction of general anesthesia.	Device: Video lighted stylet; A video lighted stylet used to facilitate endotracheal intubation after induction of general anesthesia.
Active Comparator: Visual intubation fiberscope group; Participants randomized to this arm will undergo tracheal intubation using a visual intubation fiberscope after induction of general anesthesia.	Device: Visual intubation fiberscope; A visual intubation fiberscope used to facilitate endotracheal intubation after induction of general anesthesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Guangzhou University of Chinese Medicine
• Investigators: Principal Investigator: Wuhua Ma, MD, The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: June 30, 2026
• First Submitted That Met QC Criteria: July 8, 2026
• First Posted (Actual): July 13, 2026

Study Record Updates

• Last Update Posted (Actual): July 13, 2026
• Last Update Submitted That Met QC Criteria: July 8, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Randomized controlled trial; SPHI-II; Visual lighted stylet; Visual intubation fiberscope; First-attempt intubation success
• Other Study ID Numbers: GZUCM1-2026-06; K-2025-214 (Other Identifier: Ethics Committee of the First Affiliated Hospital of Guangzhou University of Chinese Medicine)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared because the study involves patient-level clinical data and no formal data-sharing plan has been established.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No