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

NCT07699653 | Not Yet Recruiting

• 2 other identifiers: GZUCM1-2026-06K-2025-214
• Study Type: interventional
• Target: 549
• Locations: 1 country
• Sites: 1

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.

Conditions

Airway Management; General Anesthesia; Tracheal Intubation

Keywords

SPHI-II; Visual lighted stylet; Visual intubation fiberscope; First-attempt intubation success; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Intubation time

  During the intubation procedure

• Number of intubation attempts

  During the intubation procedure

• Incidence of hypoxemia

  During the intubation procedure

• Incidence of airway-related complications

  During and immediately after the intubation procedure

• Peri-intubation heart rate

  From baseline before induction to 2 minutes after successful tracheal intubation

Study Arms (3)

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.

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.

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.

Device: Visual intubation fiberscope

Interventions

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.

SPHJ-II group

Video lighted stylet DEVICE

A video lighted stylet used to facilitate endotracheal intubation after induction of general anesthesia.

Video lighted stylet group

Visual intubation fiberscope DEVICE

A visual intubation fiberscope used to facilitate endotracheal intubation after induction of general anesthesia.

Visual intubation fiberscope group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangzhou University of Chinese Medicine: lead

Study Sites (1)

The First Affiliated Hospital of Guangzhou University of Chinese Medicine

Guangzhou, Guangdong, China

Location

Study Officials

• Wuhua Ma, MD

  The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiacheng Fu

CONTACT

+86 19195352749; 15797895330@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: June 30, 2026
• First Posted: July 13, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 13, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)