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临床试验/NCT00135252
NCT00135252终止2 期

Method of Oxygen Delivery (Comparison Nasal Cannula vs Oxygen Hood) and the Effect on Transcutaneous PaCO2

The University of Texas Health Science Center, Houston1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2005年8月1日最近更新:
适应症

试验速览

阶段
2 期
状态
终止
入组人数
44
试验地点
1
主要终点
Change in transcutaneous PaCO2

研究概览

简要总结

Infants of < 1500 grams of birth weight who require a > 1 week mechanical ventilation (breathing machine) or CPAP [continuous positive airway pressure] (oxygen at a high flow through the nose) may have prolonged oxygen requirements. The nasal cannula (oxygen through the nose at a low flow) is the most commonly used method of oxygen administration, despite a lack of data regarding its safety and efficacy. Low birth weight infants are vulnerable to obstruction from secretions and blood, as well as the presence of the nasal cannula. Partially obstructed nostrils greatly increase the work of breathing. Additional potential adverse effects include an increased need for suctioning, increased risk for systemic infection, and inadvertent positive end expiratory pressure (CPAP). No study has been conducted to evaluate the efficacy of the nasal cannula compared to an oxygen hood (plastic "hood" that is placed over the infant's head to provide oxygen) on gas exchange or infection.

Among infants who require supplemental oxygen (by either a nasal cannula or an oxygen hood) for clinical indications, objectives the investigators hope to accomplish in a randomized blinded (investigator) trial:

Aim 1: To determine the short-term effect of different flows of oxygen by the nasal cannula on transcutaneous PCO2 (PTCO2).

Aim 2: To determine, once optimal flow is established in Aim 1, the effect of prolonged (one week) use of a nasal cannula compared to an oxygen hood on PTCO2.

详细描述

Specific Question:

Among low birth weight infants with a supplemental oxygen requirement, do modifications in the flow (L/min) of nasal cannula gas alter the level of transcutaneous PCO2 in the short term (30 minutes) or longer term (one week)?

Objectives:

Aim 1: To determine the short-term effect of different flows of oxygen by the nasal cannula on transcutaneous PCO2.

Aim 2: To determine, once optimal flow is established in Aim 1, the effect of prolonged (one week) use of a nasal cannula compared to an oxygen hood on transcutaneous PCO2.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single

入排标准

年龄范围
1 Week 至 6 Months(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Infants with an oxygen requirement (FiO2 of > 0.3 to maintain pulse oxygen saturations 85-95%)
  • •On the ventilator or nasal continuous positive airway pressure (NCPAP) for > 1 week ready to be changed to nasal cannula
  • •Weight less than 2500 grams and < 1500 grams birth weight

排除标准

  • •Obvious chromosomal or congenital anomaly for craniofacial or respiratory system anomalies
  • •Known significant congenital heart disease (excluding patent ductus arteriosus)
  • •Seizures or known neuromuscular disease
  • •Received steroids in week prior to eligibility

结局指标

主要结局

Change in transcutaneous PaCO2

次要结局

  • Heart rate, respiratory rate, apnea, escalation in respiratory care (CPAP, mechanical ventilation, methylxanthines, diuretics, steroids), proven sepsis

研究者

研究点 (1)

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