Application of HFNC for the Prevention of Hypoxemia During Perioperative Anesthetic-induced Intubation in Children: A Randomized Controlled Clinical Trial

Children Clinical Trial

Official title:

Application of HFNC for the Prevention of Hypoxemia During Perioperative Anesthetic-induced Intubation in Children: A Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06425406
• Other study ID #: HFNC
• Status: Recruiting
• Phase: N/A
• 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
• 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;

Related Conditions & MeSH terms

• Children
• High-flow Nasal Cannula
• Hypoxia
• Pre-oxygenation

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