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NCT Number: NCT06425406

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

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.

Recruiting

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Key information

Age range

2 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Zhengzhou, Henan, China

Location status: Recruiting

Location contact

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

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.

Primary outcomes

  1. Apnoea time

    Time frame: 2-10min

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

Study contacts

Contact information is provided by the study sponsor or research team.

Jun Zhou, PHD

CONTACT

[email protected]

+8613592582222

KuangYu Zhao

CONTACT

[email protected]

+8613251535857

Sponsors and collaborators

Lead sponsor

Henan Provincial People's Hospital

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 22, 2024
Registry last updated
Dec 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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