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NCT Number: NCT07563075

Effect of High-Flow Nasal Cannula Oxygen Therapy on Hypoxemia in Pediatric Sedated Bronchoscopy

Due to children's lower oxygen reserves and higher oxygen consumption, sedation can easily lead to respiratory adverse events such as hypoxemia. It has been reported that the incidence of hypoxemia during pediatric bronchoscopy is high, highlighting that hypoxemia in pediatric painless bronchoscopy is an urgent problem requiring a solution. High-flow nasal cannula (HFNC) oxygen therapy delivers heated and humidified breathing gas with a precisely controllable oxygen concentration, at flow rates exceeding the patient's peak inspiratory flow, directly via unsealed nasal prongs. It is a simple, comfortable, effective, and non-invasive respiratory support method that has been widely adopted in clinical practice. However, the effectiveness of HFNC in pediatric sedation remains unclear. Therefore, this multicenter randomized controlled trial aims to evaluate whether HFNC can effectively reduce the occurrence of hypoxemia during sedated bronchoscopy in pediatric patients.

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Key information

Conditions

Hypoxemia Hypoxia Infections Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Pathological Conditions, Signs and Symptoms Pneumonia Pulmonary Neoplasm Respiratory Tract Diseases Respiratory Tract Infections Respiratory Tract Neoplasms Signs and Symptoms Signs and Symptoms, Respiratory Thoracic Neoplasms

Age range

1 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 1 year ≤ age ≤ 6 years,
  • Weight ≥ 10 kg,
  • Undergoing elective sedated bronchoscopy,
  • Expected procedure duration ≤ 45 minutes,
  • Written informed consent obtained from the subject's legal guardian.

Exclusion criteria

  • preoperative SpO₂ < 95% on room air,
  • Already sedated and tracheally intubated,
  • Known history of pneumothorax, known congenital or acquired upper airway abnormalities (e.g., nasopharyngeal structural anomalies), or history of difficult airway,
  • Coagulation disorders or predisposition to oral/nasal bleeding, mucosal injury, or space-occupying lesions,
  • Severe cardiac insufficiency (< 4 METs), severe renal insufficiency (requiring dialysis), diagnosed severe hepatic insufficiency, Increased intracranial pressure, or ASA classification ≥ IV,
  • Allergy to propofol or sufentanil,
  • Multiple traumatic injuries,
  • Current participation in another clinical trial,
  • Other conditions deemed unsuitable by the investigator.

Treatment and study plan

High-flow nasal cannula

Device

Using High-flow nasal cannula oxygenation

Regular Nasal Cannula

Device

Using regular nasal cannula for oxygenation

Primary outcomes

  1. The incidence of hypoxemia

    Time frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours

    75% ≤ SpO2 < 90% for <60 s

Secondary outcomes

  1. The incidence of sub-clinical respiratory depression

    Time frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours

    90% ≤ SpO2 < 95%

  2. The incidence of severe hypoxia

    Time frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours

    SpO2 < 75% or 75% ≤ SpO2 < 90% for ≥60 s

  3. Incidence of Other Adverse Events (Excluding Respiratory-Related)

    Time frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours

    Other adverse events recorded by tools proposed by the World Society of Intravenous Anesthesia International Sedation Task Force

  4. Incidence of Other Respiratory-Related Adverse Events

    Time frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours

Other outcomes

  1. Incidence of emergence delirium in pediatric anesthesia

    Time frame: Time Frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours

    Incidence of emergence delirium in pediatric anesthesia- defined as a Pediatric Anesthesia Emergence Delirium scale score ≥10.

    Unit of measure: percentage of patients (%).

  2. Length of stay in the Post-Anesthesia Care Unit (PACU)

    Time frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours

    Time from PACU admission until discharge criteria are met (modified Aldrete score ≥9).

    Unit of measure: minutes.

Study contacts

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

Diansan Su

CONTACT

[email protected]

+86 18616514088

Mingxia Xu

CONTACT

[email protected]

+86 13516713435

Sponsors and collaborators

Lead sponsor

Zhejiang University

Other

Registry information

Official study title

Effect of High-Flow Nasal Cannula Oxygen Therapy on Hypoxemia in Pediatric Sedated Bronchoscopy: A Multicenter Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 1, 2026
Registry last updated
May 1, 2026

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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