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

5 september 2026 bijgewerkt door: 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.

Studie Overzicht

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

549

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

    • Guangdong
      • Guangzhou, Guangdong, China, 510405
        • Werving
        • The First Affiliated Hospital of Guangzhou University of Chinese Medicine
        • Contact:
          • Jiacheng Principal Investigator, MD
          • Telefoonnummer: +8615797895330
          • E-mail: 15797895330@163.com
        • Hoofdonderzoeker:
          • Jiacheng Fu, MD

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Actieve vergelijker: 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.
Actieve vergelijker: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
First-attempt intubation success rate
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Intubation time
Tijdsspanne: 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
Tijdsspanne: During the intubation procedure
Total number of attempts required to achieve successful tracheal intubation.
During the intubation procedure
Incidence of hypoxemia
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

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

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

10 juli 2026

Primaire voltooiing (Geschat)

31 oktober 2026

Studie voltooiing (Geschat)

31 december 2026

Studieregistratiedata

Eerst ingediend

30 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

8 juli 2026

Eerst geplaatst (Werkelijk)

13 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

9 september 2026

Laatste update ingediend die voldeed aan QC-criteria

5 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

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

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

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

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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