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

8. Juli 2026 aktualisiert von: Fu Jiacheng, Guangzhou University of Chinese Medicine

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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

549

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • China
    • Guangdong
      • Guangzhou, Guangdong, China
        • The First Affiliated Hospital of Guangzhou University of Chinese Medicine
        • Kontakt:
        • Hauptermittler:
          • Wuhua Ma, MD

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Gerät: SPHJ-II
The SPHJ-II is a visual adjustable red-light tracheal intubation device used to facilitate endotracheal intubation after induction of general anesthesia.
Aktiver Komparator: Video lighted stylet group
Participants randomized to this arm will undergo tracheal intubation using a video lighted stylet after induction of general anesthesia.
Gerät: Video lighted stylet
A video lighted stylet used to facilitate endotracheal intubation after induction of general anesthesia.
Aktiver Komparator: Visual intubation fiberscope group
Participants randomized to this arm will undergo tracheal intubation using a visual intubation fiberscope after induction of general anesthesia.
Gerät: Visual intubation fiberscope
A visual intubation fiberscope used to facilitate endotracheal intubation after induction of general anesthesia.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
First-attempt intubation success rate
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Intubation time
Zeitfenster: 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
Zeitfenster: During the intubation procedure
Total number of attempts required to achieve successful tracheal intubation.
During the intubation procedure
Incidence of hypoxemia
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Guangzhou University of Chinese Medicine

Ermittler

  • Hauptermittler: Wuhua Ma, MD, The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Juli 2026

Primärer Abschluss (Geschätzt)

31. Oktober 2026

Studienabschluss (Geschätzt)

31. Dezember 2026

Studienanmeldedaten

Zuerst eingereicht

30. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

8. Juli 2026

Zuerst gepostet (Tatsächlich)

13. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

13. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

8. Juli 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Andere Studien-ID-Nummern

  • GZUCM1-2026-06
  • K-2025-214 (Andere Kennung: Ethics Committee of the First Affiliated Hospital of Guangzhou University of Chinese Medicine)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

Individual participant data will not be shared because the study involves patient-level clinical data and no formal data-sharing plan has been established.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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