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

NCT06425406 | Recruiting

• 1 other identifier: HFNC
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

High-flow Nasal Cannula; Children; Pre-oxygenation

Outcome Measures

Primary Outcomes (1)

• Apnoea time

  Investigators will record the time of oxygen saturation drop to 95 % during intubation.

  2-10min

Study Arms (2)

Group HFNC

EXPERIMENTAL

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.

Device: high-flow nasal cannula

Group control

NO INTERVENTION

No intervention

Interventions

high-flow nasal cannula 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 HFNC

Eligibility Criteria

• Age: 2 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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 may not qualify if:

• 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;

Sponsors & Collaborators

• Henan Provincial People's Hospital: lead

Study Sites (1)

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

Zhengzhou, Henan, China

RECRUITING

Study Officials

• Jun Zhou, PHD

  Henan Provincial People's Hospital

  STUDY CHAIR

Central Study Contacts

KuangYu Zhao

CONTACT

+8613251535857; 844523078@qq.com

Jun Zhou, PHD

CONTACT

+8613592582222; zhoujun@zzu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2024
• First Posted: May 22, 2024
• Study Start: June 15, 2024
• Primary Completion: November 30, 2025
• Study Completion: November 30, 2025
• Last Updated: December 1, 2025

Record last verified: 2025-11

Locations

CN (1)