Airway ManagementNCT07699653
Comparison of Three Airway Intubation Devices for First-Attempt Success in General Anesthesia Patients
A study testing SPHJ-II, Video lighted stylet and Visual intubation fiberscope in people with Airway Management and General Anesthesia, run by Guangzhou University of Chinese Medicine at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Airway Management, General Anesthesia, Tracheal Intubation
- What is being tested?
- SPHJ-II, Video lighted stylet and Visual intubation fiberscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 542 participants
- Where
- 1 siteChina
- Study dates
- 10 Jul 2026to 1 Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Guangzhou, Guangdong, 510405
About this study
Official title: 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?
Read more
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.
Read the 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.
Recruitment was completed on September 30, 2026. Primary outcome data collection was completed on September 30, 2026. Collection of secondary outcomes and all adverse events was completed on October 1, 2026.
- Conditions
- Airway Management, General Anesthesia, Tracheal Intubation
- Being tested
- SPHJ-II, Video lighted stylet, Visual intubation fiberscope
- Keywords
- SPHI-II, Visual lighted stylet, Visual intubation fiberscope, First-attempt intubation success, Randomized controlled trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPHJ-IIDevice
The SPHJ-II is a visual adjustable red-light tracheal intubation device used to facilitate endotracheal intubation after induction of general anesthesia.
Video lighted styletDevice
A video lighted stylet used to facilitate endotracheal intubation after induction of general anesthesia.
Visual intubation fiberscopeDevice
A visual intubation fiberscope used to facilitate endotracheal intubation after induction of general anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: SPHJ-II |
| 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. Receives: Device: Video lighted stylet |
| 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. Receives: Device: Visual intubation fiberscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During the intubation procedure
Secondary outcomes (8)
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.
Measured: During the intubation procedure
Number of intubation attempts
Total number of attempts required to achieve successful tracheal intubation.
Measured: During the intubation procedure
Incidence of hypoxemia
Occurrence of oxygen desaturation during tracheal intubation according to the study safety criteria.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: From baseline before induction to 2 minutes after successful tracheal intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start10 Jul 2026
- Primary completion30 Sep 2026
- Study completion1 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway ManagementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 542 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangzhou University of Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fu Jiacheng, Guangzhou University of Chinese Medicine
- Investigators
- Wuhua Ma, MD, Principal investigator, The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07699653
- Sponsor's protocol ID
- GZUCM1-2026-06
- Other IDs
- K-2025-214
- Status last verified
- Oct 2026
- First submitted
- 30 Jun 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the study involves patient-level clinical data and no formal data-sharing plan has been established.
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of SPHJ-II, Visual Lighted Stylet, and Visual Intubation Fiberscope in Endotracheal Intubation in Patients Under General Anesthesia
- ClinicalTrials.gov ID
- NCT07699653
- Acronym / sponsor ID
- GZUCM1-2026-06
- Conditions
- Airway Management, General Anesthesia, Tracheal Intubation
- Keywords
- SPHI-II, Visual lighted stylet, Visual intubation fiberscope, First-attempt intubation success, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 542 participants (actual)
- Lead sponsor
- Guangzhou University of Chinese MedicineUniversity, hospital or other
- Study start
- 10 Jul 2026 (actual)
- Primary completion
- 30 Sep 2026 (actual)
- Study completion
- 1 Oct 2026 (actual)
- First posted
- 13 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Recruitment was completed on September 30, 2026. Primary outcome data collection was completed on September 30, 2026. Collection of secondary outcomes and all adverse events was completed on October 1, 2026.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| SPHJ-II group | Experimental | Device: SPHJ-IIParticipants 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 | Device: Video lighted styletParticipants randomized to this arm will undergo tracheal intubation using a video lighted stylet after induction of general anesthesia. |
| Visual intubation fiberscope group | Active comparator | Device: Visual intubation fiberscopeParticipants randomized to this arm will undergo tracheal intubation using a visual intubation fiberscope after induction of general anesthesia. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SPHJ-IIThe SPHJ-II is a visual adjustable red-light tracheal intubation device used to facilitate endotracheal intubation after induction of general anesthesia. | Device | SPHJ-II group |
| Video lighted styletA video lighted stylet used to facilitate endotracheal intubation after induction of general anesthesia. | Device | Video lighted stylet group |
| Visual intubation fiberscopeA visual intubation fiberscope used to facilitate endotracheal intubation after induction of general anesthesia. | Device | Visual intubation fiberscope group |
Primary outcome
First-attempt intubation success rate
Time frame: 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.
8 secondary outcomes
Intubation time
Time frame: During the intubation procedure
Number of intubation attempts
Time frame: During the intubation procedure
Incidence of hypoxemia
Time frame: During the intubation procedure
Incidence of airway-related complications
Time frame: During and immediately after the intubation procedure
Peri-intubation heart rate
Time frame: From baseline before induction to 2 minutes after successful tracheal intubation
Peri-intubation oxygen saturation
Time frame: From baseline before induction to 2 minutes after successful tracheal intubation
Peri-intubation systolic blood pressure
Time frame: From baseline before induction to 2 minutes after successful tracheal intubation
Peri-intubation diastolic blood pressure
Time frame: From baseline before induction to 2 minutes after successful tracheal intubation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the study involves patient-level clinical data and no formal data-sharing plan has been established.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wuhua Ma, MD principal investigator
The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SPHJ-II, Video lighted stylet and Visual intubation fiberscope in people with Airway Management and General Anesthesia, run by Guangzhou University of Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First-attempt intubation success rate (time frame: During the intubation procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.