- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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.
Přehled studie
Postavení
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Jiacheng Fu
- Telefonní číslo: +86 19195352749
- E-mail: 15797895330@163.com
Studijní místa
-
-
Guangdong
-
Guangzhou, Guangdong, Čína
- The First Affiliated Hospital of Guangzhou University of Chinese Medicine
-
Kontakt:
- Jiacheng Fu
- Telefonní číslo: +86 19195352749
- E-mail: 15797895330@163.com
-
Vrchní vyšetřovatel:
- Wuhua Ma, MD
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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.
|
The SPHJ-II is a visual adjustable red-light tracheal intubation device used to facilitate endotracheal intubation after induction of general anesthesia.
|
|
Aktivní komparátor: Video lighted stylet group
Participants randomized to this arm will undergo tracheal intubation using a video lighted stylet after induction of general anesthesia.
|
A video lighted stylet used to facilitate endotracheal intubation after induction of general anesthesia.
|
|
Aktivní komparátor: Visual intubation fiberscope group
Participants randomized to this arm will undergo tracheal intubation using a visual intubation fiberscope after induction of general anesthesia.
|
A visual intubation fiberscope used to facilitate endotracheal intubation after induction of general anesthesia.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
First-attempt intubation success rate
Časové okno: 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.
|
During the intubation procedure
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Intubation time
Časové okno: During the intubation procedure
|
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
Časové okno: During the intubation procedure
|
Total number of attempts required to achieve successful tracheal intubation.
|
During the intubation procedure
|
|
Incidence of hypoxemia
Časové okno: During the intubation procedure
|
Occurrence of oxygen desaturation during tracheal intubation according to the study safety criteria.
|
During the intubation procedure
|
|
Incidence of airway-related complications
Časové okno: During and immediately after the intubation procedure
|
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
Časové okno: From baseline before induction to 2 minutes after successful tracheal intubation
|
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
Časové okno: From baseline before induction to 2 minutes after successful tracheal intubation
|
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
Časové okno: From baseline before induction to 2 minutes after successful tracheal intubation
|
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
Časové okno: From baseline before induction to 2 minutes after successful tracheal intubation
|
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
|
Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Wuhua Ma, MD, The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- GZUCM1-2026-06
- K-2025-214 (Jiný identifikátor: Ethics Committee of the First Affiliated Hospital of Guangzhou University of Chinese Medicine)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na Řízení dýchacích cest
-
Ohio State UniversityStaženoManagement medikamentózní terapie | Management léků | Odhadované vyhnutí se nákladům | MTM
-
Wolfson Medical CenterNeznámýOvládnutí bolesti | Postchirurgický management | Management zánětuIzrael
-
Vanderbilt University Medical CenterThe Gerber FoundationDokončeno
-
University of California, Los AngelesZatím nenabírámeManagement pooperační bolesti
-
Schulthess KlinikZatím nenabírámeKrevní management pacienta
-
Kanuni Sultan Suleyman Training and Research HospitalDokončeno
-
Aydin Adnan Menderes UniversityDokončenoManagement pooperační bolestiTurecko (Türkiye)
-
Geisinger ClinicStaženo
-
University of VirginiaZatím nenabírámeContingency Management | Použití stimulantu
Klinické studie na SPHJ-II
-
Sun Pharmaceutical Industries LimitedMoebius Medical Ltd.; Nordic Bioscience Clinical Development (NBCD)DokončenoOsteoartróza koleneSpojené státy, Dánsko, Hongkong
-
Sohag UniversityNáborNovorozenecká smrtEgypt
-
Guidant CorporationPozastaveno
-
Oregon Health and Science UniversityNational Institute on Aging (NIA)DokončenoDemence | Alzheimerova nemoc | Vztah, manželský | Stresový syndrom pečovateleSpojené státy
-
University Hospital, MontpellierDokončenoPoruchy autistického spektra
-
St. Olavs HospitalSmith & Nephew, Inc.StaženoArtroplastika | Artritida kolena | Analýza chůzeNorsko
-
Smith & Nephew, Inc.Aktivní, ne náborOsteoartróza, kolenoSpojené státy, Španělsko, Spojené království
-
Jarvik Heart, Inc.NáborSrdeční selháníSpojené státy
-
TC Erciyes UniversityZatím nenabírámeNeuropatická bolest | Diabetes mellitus 2. typu (T2DM)Turecko (Türkiye)