Actively Recruiting
Application of HFNC for the Prevention of Hypoxemia During Perioperative Anesthetic-induced Intubation in Children: A Randomized Controlled Clinical Trial
Led by Henan Provincial People's Hospital · Updated on 2025-12-01
48
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the use of high-flow nasal cannula (HFNC) oxygen therapy to prevent low oxygen levels (hypoxemia) during anesthesia-induced tracheal intubation in children aged 2 to 10 years. Children have higher metabolic needs and are more likely to experience airway collapse and low oxygen during intubation compared to adults. Because spontaneous breathing stops at anesthesia induction, oxygen is rapidly used up, increasing the risk of serious complications. Ultrasound is also used to help diagnose stomach swelling during the procedure. Participants are randomly assigned to one of two groups. In the HFNC group, after the child stops breathing spontaneously, mask ventilation is done until oxygen levels reach 90%, then the mask is removed and HFNC oxygen is provided through nasal tubes to maintain oxygen during apnea. Intubation or laryngeal mask placement is performed afterward while HFNC continues. The control group receives no intervention. The study uses the AIRVO2 device for HFNC and monitors apnea time between 2 to 10 minutes. During the study, researchers will assess how long children can safely hold their breath without oxygen drops and monitor oxygen levels throughout the procedure. Children are evaluated for lung and heart health, cooperation, and anesthesia risk level before participation. The study includes triple masking to reduce bias and will run until November 2025. Safety and oxygenation effectiveness during intubation are the main focuses, with follow-up occurring during the perioperative period.
CONDITIONS
Brief Title
Application of HFNC for the Prevention of Hypoxemia During Perioperative Anesthetic-induced Intubation in Children: A Randomized Controlled Clinical Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 2-10 years old
- American Society of Anesthesiologists (ASA) Level I or II
- Children with healthy lungs and hearts
- Clear headed and able to cooperate with anesthesiologists for treatment
You will not qualify if you...
- Contraindications for HFNC: complete obstruction of the upper respiratory tract
- Contraindications for HFNC: skull base fracture or nasal bone fracture
- Patients who refuse to use HFNC
- ASA rating greater than Level II
- Children with upper respiratory tract infections within 2 weeks
- Pulmonary dysfunction
- Congenital heart disease in children
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single perioperative period
Participants undergo anesthesia induction and intubation where high-flow nasal cannula (HFNC) oxygen therapy is applied during apnea to prevent hypoxemia.
1 visit (in-person during surgery)
Trial Site Locations
Total: 1 location
1
Department of Anaesthesiology and Perioperative Medicine, People's Hospital of Zhengzhou University, Henan Provincial People's Hospital
Zhengzhou, Henan, China
Actively Recruiting
Research Team
K
KuangYu Zhao
J
Jun Zhou, PHD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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