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Application of a New Sealed Auxiliary Ventilation Device in Painless Fiberoptic Bronchoscopy: A Prospective Randomized Controlled Study

Application of a New Sealed Auxiliary Ventilation Device in Painless Fiberoptic Bronchoscopy: A Prospective Randomized Controlled Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600128037
Enrollment
Unknown
Registered
2026-07-13
Start date
2025-11-04
Completion date
Unknown
Last updated
2026-07-20

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

Conditions

Respiratory diseases

Interventions

control group:When the patient's eyelash reflex disappears, insert a conventional oropharyngeal airway and deliver oxygen via a nasal cannula placed through the oropharyngeal airway.
experimental group:Once the patient's eyelash reflex disappears, insert a sealed oropharyngeal airway, apply the film to seal the nasal and oral area, creating an enclosed respiratory space. Then conn

Sponsors

Foshan Hospital of Traditional Chinese Medicine?
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Age = 18 years. 2.American Society of Anesthesiologists (ASA) physical status classification of I to III 3.Scheduled for elective fiberoptic bronchoscopy (FOB) under intravenous general anesthesia . 4.Voluntary participation and provision of signed informed consent.

Exclusion criteria

Exclusion criteria: 1.Severe cardiopulmonary insufficiency. 2.Uncorrectable coagulation disorders. 3.Severe hepatic or renal disease. 4.Acute exacerbation of asthma. 5.Increased intracranial pressure or impaired consciousness. 6.Allergy to anesthetic drugs. 7.Pregnancy. 8.Peripheral oxygen saturation (SpO2) < 90% while breathing room air preoperatively. 9.Conditions such as trismus, history of nasopharyngeal surgery, nasal deformity, etc. 10.Refusal to sign the informed consent form.

Design outcomes

Primary

MeasureTime frame
Incidence and duration of intraoperative hypoxemia (SpO2 < 90%).;

Secondary

MeasureTime frame
Incidence and duration of severe hypoxemia (SPO2 < 60%).;Use of antagonists;Incidence of procedure termination;Positive pressure oxygen administration;

Countries

China

Contacts

Public ContactYu jianhua

Foshan Hospital of Traditional Chinese Medicine?

jianhuatie@163.com+86 180 3324 9796

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 23, 2026