- ICH GCP
- USA klinikai vizsgálatok nyilvántartása
- Klinikai vizsgálat NCT07699653
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.
A tanulmány áttekintése
Állapot
Körülmények
Beavatkozás / kezelés
Részletes leírás
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.
Tanulmány típusa
Beiratkozás (Becsült)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Tanulmányi kapcsolat
- Név: Jiacheng Fu
- Telefonszám: +86 19195352749
- E-mail: 15797895330@163.com
Tanulmányi helyek
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Guangdong
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Guangzhou, Guangdong, Kína, 510405
- Toborzás
- The First Affiliated Hospital of Guangzhou University of Chinese Medicine
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Kapcsolatba lépni:
- Jiacheng Principal Investigator, MD
- Telefonszám: +8615797895330
- E-mail: 15797895330@163.com
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Kutatásvezető:
- Jiacheng Fu, MD
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Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
- Felnőtt
- Idősebb felnőtt
Egészséges önkénteseket fogad
Leírás
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.
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Kezelés
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Kettős
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
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Kísérleti: 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.
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The SPHJ-II is a visual adjustable red-light tracheal intubation device used to facilitate endotracheal intubation after induction of general anesthesia.
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Aktív összehasonlító: Video lighted stylet group
Participants randomized to this arm will undergo tracheal intubation using a video lighted stylet after induction of general anesthesia.
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A video lighted stylet used to facilitate endotracheal intubation after induction of general anesthesia.
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Aktív összehasonlító: Visual intubation fiberscope group
Participants randomized to this arm will undergo tracheal intubation using a visual intubation fiberscope after induction of general anesthesia.
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A visual intubation fiberscope used to facilitate endotracheal intubation after induction of general anesthesia.
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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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First-attempt intubation success rate
Időkeret: During the intubation procedure
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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.
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During the intubation procedure
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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Intubation time
Időkeret: During the intubation procedure
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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.
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During the intubation procedure
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Number of intubation attempts
Időkeret: During the intubation procedure
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Total number of attempts required to achieve successful tracheal intubation.
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During the intubation procedure
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Incidence of hypoxemia
Időkeret: During the intubation procedure
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Occurrence of oxygen desaturation during tracheal intubation according to the study safety criteria.
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During the intubation procedure
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Incidence of airway-related complications
Időkeret: During and immediately after the intubation procedure
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Occurrence of airway-related complications during or immediately after intubation, including oral or pharyngeal mucosal injury, bleeding, and dental injury.
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During and immediately after the intubation procedure
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Peri-intubation heart rate
Időkeret: From baseline before induction to 2 minutes after successful tracheal intubation
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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).
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From baseline before induction to 2 minutes after successful tracheal intubation
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Peri-intubation oxygen saturation
Időkeret: From baseline before induction to 2 minutes after successful tracheal intubation
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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).
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From baseline before induction to 2 minutes after successful tracheal intubation
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Peri-intubation systolic blood pressure
Időkeret: From baseline before induction to 2 minutes after successful tracheal intubation
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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).
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From baseline before induction to 2 minutes after successful tracheal intubation
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Peri-intubation diastolic blood pressure
Időkeret: From baseline before induction to 2 minutes after successful tracheal intubation
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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).
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From baseline before induction to 2 minutes after successful tracheal intubation
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Együttműködők és nyomozók
Nyomozók
- Kutatásvezető: Wuhua Ma, MD, The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
Elsődleges befejezés (Becsült)
A tanulmány befejezése (Becsült)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
Egyéb vizsgálati azonosító számok
- GZUCM1-2026-06
- K-2025-214 (Egyéb azonosító: Ethics Committee of the First Affiliated Hospital of Guangzhou University of Chinese Medicine)
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
IPD terv leírása
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