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

NCT ID: NCT06425406

Last Updated: 2025-12-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-15
• Study Completion Date: 2025-11-30

Brief 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.

Detailed 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.

Conditions

High-flow Nasal Cannula; Children; Pre-oxygenation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Group HFNC

In the HFNC group, the mask ventilation was performed after the patient lost spontaneous breathing until the end-tidal oxygen concentration reached 90 %. The mask was removed and HFNC ( AIRVO2, Fisher Parker Medical Company, Auckland, New Zealand ) was used to record the patient 's safe apnea time. After the end of positive pressure ventilation, intubation or laryngeal mask placement was performed after the end-tidal oxygen concentration reached 90 % or more. During the intubation or placement of the laryngeal mask, the HFNC nasal catheter was kept in the patient 's nose for apnea oxygenation.

Group Type: EXPERIMENTAL

high-flow nasal cannula

Intervention Type: DEVICE

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.

Group control

No intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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;

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Henan Provincial People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jun Zhou, PHD

Role: STUDY_CHAIR

Henan Provincial People's Hospital

Locations

Department of Anaesthesiology and Perioperative Medicine, People's Hospital of Zhengzhou University, Henan Provincial People's Hospital

Zhengzhou, Henan, China

Site Status: RECRUITING

Countries

China

Central Contacts

KuangYu Zhao

Role: CONTACT

844523078@qq.com

+8613251535857

Jun Zhou, PHD

Role: CONTACT

zhoujun@zzu.edu.cn

+8613592582222

Facility Contacts

Zhou Jun

Role: primary

zhoujun@zzu.edu.cn

+8613592582222

Other Identifiers

HFNC

Identifier Type: -

Identifier Source: org_study_id