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Clinical study of nasal high-flow oxygen therapy during endotracheal intubation and extubation in neonates

Clinical study of nasal high-flow oxygen therapy during endotracheal intubation and extubation under general anesthesia in neonates

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300071428
Enrollment
Unknown
Registered
2023-05-15
Start date
2023-07-01
Completion date
Unknown
Last updated
2023-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endotracheal intubation and extubation under general anesthesia in neonates

Interventions

HFNC extubation group:Nasal high-flow oxygen therapy during extubation
HFNC intubation group:Nasal high-flow oxygen therapy during intubation
Conventional oxygen intubation group:Routine oxygen during intubation
Conventional oxygen extubation group:Routine oxygen during extubation

Sponsors

Zhengzhou University Third Hospital and Henan Province Women and Children's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 1 Years

Inclusion criteria

Inclusion criteria: Vaginal birth, single birth, live birth. Apgar score of 1 at birth > 7, no history of birth asphyxia, no history of medical and surgical diseases and complications, etc.

Exclusion criteria

Exclusion criteria: Nasal catheterization, emergency intubation, pre-intubation heart rate less than 120 beats per minute, contraindications to high-flow therapy (eg, congenital nasal malformations, congenital diaphragmatic hernias, or abdominal wall defects), cyanotic congenital heart disease, heart disease, and other organic diseases. Children with acute and critical illness, those with obvious physical defects, mental illness or coma.

Design outcomes

Primary

MeasureTime frame
Minimum SpO2 at intubation;First intubation success rate;Incidence of hypoxemia (SpO2<90%) after extubation;After extubation, laryngospasm and choking appear;

Secondary

MeasureTime frame
Number of intubation attempts;Cumulative time for all intubations;Intubate again after extubation;Out of the operating room time;

Countries

China

Contacts

Public ContactWang Yuxia

The Third Affiliated Hospital of Zhengzhou University

wyxwl@zzu.edu.cn+86 182 3710 6608

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026