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Comparison of Intubation-Related Airway Mucosal Injury Between a Combined Visual Lung Isolation Tube and a Visualized Double-Lumen Tube in Thoracic Surgery: A Multicenter, Prospective, Randomized Controlled Trial

Comparison of Intubation-Related Airway Mucosal Injury Between a Combined Visual Lung Isolation Tube and a Visualized Double-Lumen Tube in Thoracic Surgery: A Multicenter, Prospective, Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600125149
Enrollment
Unknown
Registered
2026-05-21
Start date
2026-05-25
Completion date
Unknown
Last updated
2026-05-25

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

Conditions

None

Interventions

Compounded Tube Group:Endotracheal intubation and lung isolation are performed using a combined visualized lung isolation tube under video laryngoscopic guidance. Following a stepwise insertion strate
VDLT Group:Endotracheal intubation and lung isolation are performed using a visualized double-lumen tube under video laryngoscopic guidance.Following the conventional single-step insertion approach, t

Sponsors

Shanghai Pulmonary Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Age 18–75 years; 2.American Society of Anesthesiologists (ASA) physical status I–III; 3.Patients scheduled for elective thoracic surgery requiring one-lung ventilation; 4.Planned use of a left-sided lung isolation device (left-sided visualized double-lumen tube [VDLT] or placement of the inner lumen of the combined visualized lung isolation tube into the left main bronchus) to achieve lung isolation, with an expected anesthesia duration >=1 hour; 5.Ability to understand the study procedures and provide written informed consent.

Exclusion criteria

Exclusion criteria: 1.Pre-existing airway injury, sore throat, or hoarseness prior to surgery; 2.Minimal transverse tracheal diameter = 35 kg/m^2; Mallampati score of 4, etc.); 4. High-risk respiratory complications or active airway/lung inflammation (such as poorly controlled asthma, acute pharyngitis, acute exacerbation of COPD, recent pneumonia, etc.); 5. History of single-lung ventilation.

Design outcomes

Primary

MeasureTime frame
Incidence of intubation-related moderate-to-severe tracheal mucosal injury;

Secondary

MeasureTime frame
Site-specific tracheal mucosal injury scores;Incidence of vocal cord injury;Incidence and severity of postoperative sore throat;Incidence and severity of postoperative hoarseness;Intubation time;Number of intubation attempts;Quality of lung collapse;Intraoperative peak airway pressure and plateau pressure;

Countries

China

Contacts

Public ContactXin Lv

Shanghai Pulmonary Hospital

xinlvg@126.com+86 136 6186 9972

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 9, 2026