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A study of microbypass end-expiratory carbon dioxide monitoring to detect hypoxia during sedation for MRI examination in children with developmental delay

A study of microbypass end-expiratory carbon dioxide monitoring to detect hypoxia during sedation for MRI examination in children with developmental delay

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400092988
Enrollment
Unknown
Registered
2024-11-26
Start date
2024-12-01
Completion date
Unknown
Last updated
2024-12-02

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

Conditions

Hypoxia research

Interventions

Gold Standard:Pulse oximetry (SpO2) monitoring is recognized by the World Health Organization as the best way to detect hypoxemia and is considered an essential intervention for child health.
Index test:Microparasitic end-expiratory carbon dioxide monitoring.

Sponsors

Fujian Children's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1.American Society of Anaesthesiologists Classification (ASA) I-II; 2.Children between the ages of 3 and 12, regardless of gender; 3.Meets the diagnostic criteria for child developmental delay in the American Academy of Pediatrics Guidelines for Developmental Assessment; 4.Need for an MRI under sedation;

Exclusion criteria

Exclusion criteria: 1.Those who refuse dexmedetomidine nasal drops and midazolam for oral sedation; 2.Failure of sedation occurs including those who do not cooperate with nasal or oral sedation drops, those who are unable to achieve moderate to deep sedation at the dose set for this study, and those who require remedial medication during the examination process; 3.Adverse events other than hypoxia, such as drug allergy, choking, vomiting and aspiration, that require termination of the test; 4.Those whose child's guardian does not consent to participate in the study;

Design outcomes

Primary

MeasureTime frame
Incidence of hypoxia;Accuracy;Sensitivity;Specificity;

Secondary

MeasureTime frame
Positive predicative value;Negative predictive value;

Countries

China

Contacts

Public ContactGuanlin Zheng

Fujian Children's Hospital

1365703233@qq.com+86 133 2823 3732

Outcome results

None listed

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