The role of supraglottic oxygenation in soft fiber bronchoscopy under general anesthesia to preserve spontaneous respiration: a prospective, randomized, controlled clinical trial

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2400080865

Enrollment

Unknown

Registered

2024-02-09

Start date

2024-02-18

Completion date

Unknown

Last updated

2024-02-11

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

Conditions

Patients undergoing soft fiber bronchoscopy

Interventions

Nasal duct group:Nasal cannula oxygenation

Supraglottic group:Supraglottic oxygenation

Eligibility

Sex/Gender

All

Age

18 Years to 90 Years

Inclusion criteria

Inclusion criteria: (1) = 18 years old; (2) American Society of Anesthesiologists (ASA) = Level III. According to the American Society of Anesthesiologists, patients are classified into I-III levels based on their physical condition and surgical risk before anesthesia. Level I includes physical health, good development and nutrition, and normal organ function. Perioperative mortality rate is 0.06% -0.08%; Level II: Except for surgical diseases, there are mild comorbidities and functional compensation is sound. Perioperative mortality rate is 0.27% -0.40%; Level III: Severe coexisting condition with limited physical activity, but still able to cope with daily activities. The perioperative mortality rate is 1.82% -4.30%.

Exclusion criteria

Exclusion criteria: (1) Coagulation dysfunction or tendency for nosebleeds; (2) Long term oxygen therapy or home mechanical ventilation; (3) History of emphysema and spontaneous pneumothorax; (4) Recent (within 1 week) thoracic surgery and presence of chest skin lesions; (5) Tracheostomy; (6) Difficult airway; Anesthesiologists with over five years of clinical anesthesia experience may encounter difficulties during mask ventilation (upper respiratory obstruction), tracheal intubation, or a combination of both clinical conditions. (7) Infection of mouth, nose or throat; (8) Fever, defined as core body temperature>37.5 ?; (9) Elevated intracranial pressure; (10) Have a history of severe heart, brain, lung, liver, kidney or metabolic diseases; (11) American Society of Anesthesiologists (ASA)>Level III; (12) Unable to express informed consent and agreed to withdraw; (13) Incorporate into other research plans.

Design outcomes

Primary

Measure	Time frame
Hypoxia incidence rate;	—

Secondary

Measure	Time frame
Subclinical respiratory depression;Severe hypoxia;The incidence of other adverse events;	—

Countries

China

Contacts

Public ContactZhu Yana

The Fourth Affiliated Hospital of Harbin Medical University

2391234775@qq.com+86 131 3668 3638

Outcome results

None listed

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