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A randomized controlled clinical trial of the endoscopic video-stylet for tracheal intubation (Pulusee, TY0203AS4049) in the efficacy and safety of intubation positioning during thoracoscopic pulmonary surgery.

A randomized controlled clinical trial of the endoscopic video-stylet for tracheal intubation (Pulusee, TY0203AS4049) in the efficacy and safety of intubation positioning during thoracoscopic pulmonary surgery.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500109563
Enrollment
Unknown
Registered
2025-09-22
Start date
2025-09-29
Completion date
Unknown
Last updated
2025-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

One-lung ventilation in thoracoscopic pulmonary surgery

Interventions

experimental group:the endoscopic video-stylet for endotracheal intubation (Pulusee,TY0203AS4049) in the intubation positioning
control group:auscultation-guided intubation positioning

Sponsors

Affiliated Hospital of Nantong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
45 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Patients scheduled for thoracoscopic lobectomy or segmentectomy who require one-lung ventilation; 2.Aged 45-75 years; gender unrestricted; 3.American Society of Anesthesiologists (ASA) physical status: Class I–III; 4.Body mass index (BMI): 18.5–30 kg/m^2; 5.Voluntarily enrolled and provided written informed consent; 6.With an appropriately sized double-lumen endobronchial tube available.

Exclusion criteria

Exclusion criteria: 1.Patients with anticipated difficult tracheal intubation due to: (1).ankylosing spondylitis with limited cervical-spine mobility; (2).restricted mouth opening =180 mmHg or diastolic blood pressure is >=110 mmHg; 5.Patients with cardiac insufficiency, shock, or coma; 6.Preoperative liver or kidney function tests (ALT, AST, BUN, Cr) abnormally elevated to >1.5 times the upper limit of normal; fasting blood glucose >12 mmol/L; severe electrolyte imbalance, specifically serum potassium <3.2 mmol/L; 7.Pregnant or lactating women; 8.A history of previous abnormal anesthesia experience and recovery; 9.Patients who do not require one-lung ventilation during the perioperative period; 10.Patients whom the investigators deem unsuitable for participation in this study; Exclusion criteria: 11.Subjects who are unable to undergo tracheal intubation and surgery due to an adverse even; 12.Participants withdrawn by the investigator (due to poor compliance or serious adverse events); 13.Participants required an alternative emergent tracheal-intubation technique during the study period and therefore could not be evaluated for the device’s efficacy and safety.

Design outcomes

Primary

MeasureTime frame
First-attempt intubation positioning success rate;

Secondary

MeasureTime frame
satisfaction of anesthesiologists and surgeons with the quality of tracheal intubation;

Countries

China

Contacts

Public ContactWang Chunguang

Affiliated Hospital of Nantong University

wangchunggg@126.com+86 150 6274 5238

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026