Helium Oxygen Mixture in the Treatment of Meconium Aspiration Syndrome

Overview

Helium-oxygen mixture(heliox) was suggested to be beneficial in meconium aspiration syndrome in previous studies,but the evidence was limited.The aim of the study was to assess the effectiveness of synchronize intermittent mandatory ventilation (SIMV) with heliox (70% helium and 30% oxygen) on length of ventilation(LoV) and cardiopulmonary protection in meconium aspiration syndrome.

Full Title of Study: “Study on the Effect of Helium Oxygen Mixture in the Treatment of Meconium Aspiration Syndrome Parallel Synchronized Intermittent Mandatory Ventilation; Synchronous Maudatory Ventilation”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: February 20, 2017

Interventions

  • Device: helium oxygen mixture

Arms, Groups and Cohorts

  • Active Comparator: experimental group
    • Using helium oxygen mixture
  • No Intervention: matched group
    • Using air oxygen mixture

Clinical Trial Outcome Measures

Primary Measures

  • blood gas analysis
    • Time Frame: 2 hour
    • Time detection after treatment
  • blood gas analysis
    • Time Frame: 6 hour
  • blood gas analysis
    • Time Frame: 12 hour
  • blood gas analysis
    • Time Frame: 24 hour
  • blood gas analysis
    • Time Frame: 48 hour

Secondary Measures

  • Inflammatory response index (IL-6,IL-8, TNF-a,CRP)
    • Time Frame: 0 hour
  • Inflammatory response index (IL-6,IL-8, TNF-a,CRP)
    • Time Frame: 6 hour

Participating in This Clinical Trial

Inclusion Criteria

  • Subject has the diagnosis of neonatal meconium aspiration syndrome – Subject has Synchronous instruction ventilation Exclusion Criteria:

  • History of congenital or hereditary disease

Gender Eligibility: All

Minimum Age: 37 Weeks

Maximum Age: 40 Weeks

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Ma Juan
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Ma Juan, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University – Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

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