- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Jiacheng Fu
- Numero di telefono: +86 19195352749
- Email: 15797895330@163.com
Luoghi di studio
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Guangdong
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Guangzhou, Guangdong, Cina
- The First Affiliated Hospital of Guangzhou University of Chinese Medicine
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Contatto:
- Jiacheng Fu
- Numero di telefono: +86 19195352749
- Email: 15797895330@163.com
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Investigatore principale:
- Wuhua Ma, MD
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-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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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Comparatore attivo: 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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Comparatore attivo: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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First-attempt intubation success rate
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Intubation time
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Investigatori
- Investigatore principale: Wuhua Ma, MD, The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
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Primo Inserito (Effettivo)
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Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- GZUCM1-2026-06
- K-2025-214 (Altro identificatore: Ethics Committee of the First Affiliated Hospital of Guangzhou University of Chinese Medicine)
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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