Effect of High-Flow Nasal Cannula Oxygen Therapy on Hypoxemia in Pediatric Sedated Bronchoscopy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-6
SponsorZhejiang University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
1 year ≤ age ≤ 6 years,
Weight ≥ 10 kg,
Undergoing elective sedated bronchoscopy,
Expected procedure duration ≤ 45 minutes,
Disqualifiers
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,
Trial design
Design model
Parallel
Treatments tested in this trial
High-flow nasal cannula
DeviceUsing High-flow nasal cannula oxygenation
Regular Nasal Cannula
DeviceUsing regular nasal cannula for oxygenation
Treatment groups
430 Participants
are divided into 2 treatment groupsGroup A: High-flow nasal cannula GroupExperimental treatment 1 intervention
Group B: Regular Nasal Cannula GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
The incidence of hypoxemia
75% ≤ SpO2 \< 90% for \<60 s
Time frame
Patients will be followed for the duration of hospital stay, an expected average about 2 hoursSecondary outcomes
1
The incidence of sub-clinical respiratory depression
90% ≤ SpO2 \< 95%
Time frame
Patients will be followed for the duration of hospital stay, an expected average about 2 hours2
The incidence of severe hypoxia
SpO2 \< 75% or 75% ≤ SpO2 \< 90% for ≥60 s
Time frame
Patients will be followed for the duration of hospital stay, an expected average about 2 hours3
Incidence of Other Adverse Events (Excluding Respiratory-Related)
Other adverse events recorded by tools proposed by the World Society of Intravenous Anesthesia International Sedation Task Force
Time frame
Patients will be followed for the duration of hospital stay, an expected average about 2 hours4
Incidence of Other Respiratory-Related Adverse Events
Time frame
Patients will be followed for the duration of hospital stay, an expected average about 2 hoursOther outcomes
1
Incidence of emergence delirium in pediatric anesthesia
Incidence of emergence delirium in pediatric anesthesia- defined as a Pediatric Anesthesia Emergence Delirium scale score ≥10. Unit of measure: percentage of patients (%).
Time frame
Time Frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours2
Length of stay in the Post-Anesthesia Care Unit (PACU)
Time from PACU admission until discharge criteria are met (modified Aldrete score ≥9). Unit of measure: minutes.
Time frame
Patients will be followed for the duration of hospital stay, an expected average about 2 hoursSponsors and contacts
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Source ClinicalTrials.gov
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