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

Guangzhou University of Chinese Medicine549 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

Interventions

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: During the intubation procedure

Secondary Outcomes

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.

Time frame: During the intubation procedure

Number of intubation attempts

Total number of attempts required to achieve successful tracheal intubation.

Time frame: During the intubation procedure

Incidence of hypoxemia

Occurrence of oxygen desaturation during tracheal intubation according to the study safety criteria.

Time frame: 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.

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: From baseline before induction to 2 minutes after successful tracheal intubation

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts