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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06425406
Other study ID # HFNC
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 4, 2023
Est. completion date May 1, 2025

Study information

Verified date June 2024
Source Henan Provincial People's Hospital
Contact KuangYu Zhao
Phone +8613251535857
Email 844523078@qq.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Compared with adults, children have higher metabolic needs, and the airway is more likely to collapse. Before tracheal intubation after anesthesia induction, the patient 's spontaneous breathing completely disappears. At this critical stage, the residual oxygen of the lung is consumed, resulting in hypoxemia and atelectasis. Therefore, it is necessary to explore the best oxygenation strategy during intubation. In addition, ultrasound has become a common equipment in the operating room. It has the advantages of portability, repeatability, and no radiation, and can provide strong support for the diagnosis of gastric distension.


Description:

At present, hypoxia is still the main cause of complications and death during perioperative period. Compared with adults, children have lower functional residual volume and lower tolerance to hypoxia caused by apnea due to their special physiological and functional characteristics. During anesthesia induction and tracheal intubation, spontaneous breathing completely disappears. At this critical stage, hypoxemia is prone to occur, which in turn causes various serious complications. Mask ventilation may occur mask ventilation difficulties and flatulence ; since the introduction of nasal high-flow oxygen therapy ( HFNC ) into the operating room in 2015, its oxygenation method has been shown to be able to significantly improve blood oxygen when used alone in pre-oxygenation. When tracheal intubation is performed, HFNC can still maintain ventilation in the patient 's nose, so HFNC can combine the advantages of both masks to perform pre-oxygenation. There are few studies on the effect of HFNC on apnea oxygenation in children in the operating room.


Recruitment information / eligibility

Status Recruiting
Enrollment 48
Est. completion date May 1, 2025
Est. primary completion date May 1, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 2 Years to 10 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - Contraindications for HFNC: (1) Complete obstruction of the upper respiratory tract; (2) Skull base fracture or nasal bone fracture; (3) Patients who refuse to use HFNC; - The American Society of Anesthesiologists (ASA) rating is greater than Level II; - Children with upper respiratory tract infections within 2 weeks; - Pulmonary dysfunction, congenital heart disease in children;

Study Design


Related Conditions & MeSH terms


Intervention

Device:
high-flow nasal cannula
In group H, mask ventilation was performed after the patient lost spontaneous breathing until the end-expiratory oxygen concentration reached 90 %. The lower mask was taken and HFNC was used to record the patient 's safe apnea time.

Locations

Country Name City State
China Department of Anaesthesiology and Perioperative Medicine, People's Hospital of Zhengzhou University, Henan Provincial People's Hospital Zhengzhou Henan

Sponsors (1)

Lead Sponsor Collaborator
Henan Provincial People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Apnoea time Investigators will record the time of oxygen saturation drop to 95 % during intubation. 2-10min
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