Hypoxemia, Pneumonia, Pulmonary Neoplasm
Conditions
Keywords
Bronchoscopy, Hypoxemia, Sedation, Pediatric, High-flow nasal cannula
Brief summary
Due to children's lower oxygen reserves and higher oxygen consumption, sedation can easily lead to respiratory adverse events such as hypoxemia. It has been reported that the incidence of hypoxemia during pediatric bronchoscopy is high, highlighting that hypoxemia in pediatric painless bronchoscopy is an urgent problem requiring a solution. High-flow nasal cannula (HFNC) oxygen therapy delivers heated and humidified breathing gas with a precisely controllable oxygen concentration, at flow rates exceeding the patient's peak inspiratory flow, directly via unsealed nasal prongs. It is a simple, comfortable, effective, and non-invasive respiratory support method that has been widely adopted in clinical practice. However, the effectiveness of HFNC in pediatric sedation remains unclear. Therefore, this multicenter randomized controlled trial aims to evaluate whether HFNC can effectively reduce the occurrence of hypoxemia during sedated bronchoscopy in pediatric patients.
Interventions
DEVICEHigh-flow nasal cannula
Using High-flow nasal cannula oxygenation
DEVICERegular Nasal Cannula
Using regular nasal cannula for oxygenation
Sponsors
Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
1 Years to 6 Years
Healthy volunteers
No
Inclusion criteria
* 1 year ≤ age ≤ 6 years, * Weight ≥ 10 kg, * Undergoing elective sedated bronchoscopy, * Expected procedure duration ≤ 45 minutes, * Written informed consent obtained from the subject's legal guardian.
Exclusion criteria
* preoperative SpO₂ \< 95% on room air, * Already sedated and tracheally intubated, * Known history of pneumothorax, known congenital or acquired upper airway abnormalities (e.g., nasopharyngeal structural anomalies), or history of difficult airway, * Coagulation disorders or predisposition to oral/nasal bleeding, mucosal injury, or space-occupying lesions, * Severe cardiac insufficiency (\< 4 METs), severe renal insufficiency (requiring dialysis), diagnosed severe hepatic insufficiency, Increased intracranial pressure, or ASA classification ≥ IV, * Allergy to propofol or sufentanil, * Multiple traumatic injuries, * Current participation in another clinical trial, * Other conditions deemed unsuitable by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of hypoxemia | Patients will be followed for the duration of hospital stay, an expected average about 2 hours | 75% ≤ SpO2 \< 90% for \<60 s |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of sub-clinical respiratory depression | Patients will be followed for the duration of hospital stay, an expected average about 2 hours | 90% ≤ SpO2 \< 95% |
| The incidence of severe hypoxia | Patients will be followed for the duration of hospital stay, an expected average about 2 hours | SpO2 \< 75% or 75% ≤ SpO2 \< 90% for ≥60 s |
| Incidence of Other Adverse Events (Excluding Respiratory-Related) | Patients will be followed for the duration of hospital stay, an expected average about 2 hours | Other adverse events recorded by tools proposed by the World Society of Intravenous Anesthesia International Sedation Task Force |
| Incidence of Other Respiratory-Related Adverse Events | Patients will be followed for the duration of hospital stay, an expected average about 2 hours | — |
Countries
China
Contacts
CONTACTDiansan Su
CONTACTMingxia Xu
STUDY_CHAIRDiansan Su
Zhejiang University
Outcome results
None listed