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临床试验/NCT02375230
NCT02375230已完成不适用

MRSOPA-Drills to Improve Mask Ventilation in the Delivery Room

University of Alberta2 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2015年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
56
试验地点
2
主要终点
Mask leak

研究概览

简要总结

Establishing breathing after birth is vital for survival and long-term health of premature babies. 10% of all preterm babies fail to breathe after birth and require help with breathing. When infants need help with breathing the clinical team will place a small mask on the babies face to give some breaths to help the baby breath (what the investigators call mask ventilation).

This procedure is done million times a day around the world and several times a day here at the Royal Alexandra Hospital. Providing these breaths via mask ventilation is the most difficult step in helping a baby breath at birth. If this is provided wrongly then baby does not receive enough oxygen, which could damage the brain and even cause death.

To keep the skill level of every staff member up-to-date every staff member is required to re-train this rescue breaths via mask ventilation once every two years.

The investigators believe this is not enough and that daily trainings are necessary to keep your skills up-to-date.

The investigators aim to compare to different teaching techniques using daily trainings to see if either improves the skills of the resuscitator providing mask ventilation

The study will last 7 month (baseline observations (2 months), intervention period (3 months), After trial period (2 months)

The investigators will use our routinely used equipment to record neonatal resuscitation and the investigators also routinely make video recordings to evaluate performance during resuscitation.

详细描述

Background

Establishing breathing and oxygenation after birth is vital for survival and long-term health of premature infants. 10% of all preterm infants fail to breathe after birth and require respiratory support. An international consensus statement recommends that infants with inadequate breathing or bradycardia after birth be given positive pressure ventilation (PPV) via a facemask with a T-piece device. Mannequin and DR studies have shown that PPV is difficult and mask leak and airway obstruction are common problems during PPV. Several factors such as poor facemask application resulting in leak or airway obstruction, spontaneous movements of the baby, movements by or distraction of the resuscitator, changing the wet towels or putting a hat can reduce the effectiveness of PPV. We recently reported both that significant airway obstruction and mask leaks occur in about half of the very preterm infants who received PPV in the DR. In particular, large mask leak was observed in twice as many recordings as airway obstruction and only in about a third of recordings neither obstruction nor facemask leak occurred. In addition, mask leak was more likely to occur at the start of PPV, while airway obstruction more often occurred later on. Assessment of the infant may distract the resuscitators focus from mask position and mask holding techniques during the initial phase of PPV.

MR SOPA

Neonatal Resuscitation Program (NRP) emphasizes on the ventilation corrective steps to ensure effective mask ventilation before moving to the next steps of resuscitation. Technique for improving PPV by mask is performed by a series of corrective steps, identified by the acronym "MR SOPA", to recall ventilation corrective steps. The steps should be followed with this order: "M Mask adjustment, R Reposition airway, S Suction mouth and nose, O Open mouth, P Pressure increase, A Airway alternative".

Hypotheses to be tested

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Prevention
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
— 至 10 Minutes(Child)
性别
All
接受健康志愿者

入选标准

  • Infants <33 weeks gestation requiring respiratory support at birth will be included if member of the Resuscitation-Stabilization-Triage team (RST-team) enrolled in study attend deliveries.

排除标准

  • Infants of parents who decline consent

结局指标

主要结局

Mask leak

时间窗: within 10min after birth

次要结局

  • Apgar score at 1min(1min after birth)
  • Rate of Intubation(within 60min after birth)
  • Apgar score at 5min(5min after birth)
  • Rate of Chest compression(within 10min after birth)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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