Assessment of an Innovative Air Mattress on Critically Ill Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Interface pressure resulting from the exposure of patients to the supportive structures as measured by a pressure sensitive mat (xsensor, LX100:100.160.05, XSENSOR Technology Corporation, Calgary, Canada).
研究概览
简要总结
The permanent bedding of critically ill neonates and infants in the pediatric intensive care unit (PICU) for an extended amount of time can result in the development of pressure injuries (PI). PIs can form due to high and permanent local interface pressure induced by contact with bed surfaces or other medical devices. The currently used state-of-the-art support systems consist of conventional foam mattresses. In this study, the investigators explore the effect of a newly developed air mattress with regard to contact are and reduction in the average interface pressure in infants assigned to the pediatric intensive care unit of the childrens hospital in Zurich.
详细描述
The permanent bedding of critically ill neonates and infants in the pediatric intensive care unit (PICU) for an extended amount of time can result in the development of pressure injuries (PI). This results in a further prolongation of the hospital stay, additional suffering of the patient, scarring, increased mortality and morbidity, and increased healthcare costs. Infants are at particular risk since their skin hasn't matured yet and is mechanically weak, and for example neonates lack a robust stratum corneum entirely. Furthermore, the thickness of their skin is reduced by 60% when compared to skin of adults. Thus, pressure cannot be equally absorbed leading to higher tissue internal stress. PIs can form due to high and permanent local interface pressure induced by contact with bed surfaces or other medical devices. Contact pressure can hamper blood flow in subcutaneous areas, increasing susceptibility for pressure injuries. While sophisticated equipment to manage the interface pressure and reduce the risk of developing pressure injuries is abundant for adults, very little is designed explicitly for neonates and infants. The currently available air mattresses are not being used due to safety concerns and impracticability. Furthermore, they are designed for infants from half a year of age and, thus, not considering the low body weight of premature babies or neonates. This is why the currently used conventional foam mattresses remain first choice. However, foam mattresses are designed for optimal support of a specific weight and, therefore, making them unsuitable for the use as a one-fits-all solution in a highly heterogenic patient cohort. In addition, compressed foam gets stiffer at compressed areas, increasing the local pressure impact and, thus, PI risk. On the other hand, the structures of the hereby-developed air mattress can freely move and optimally adjust to the patient's body shape. This increases contact area, reduces the average interface pressure and blunts local pressure peaks at the areas with the most indentation, ensuring a more homogenous pressure distribution at a lower level. This ultimately is expected to result in a lower PI incidence. As a side effect, lying comfort for the patient will be increased.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 10 Days 至 6 Months(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent signed by the legal guardian
- •Admitted to the pediatric intensive care unit (PICU)
- •Age: late preterm (>34 gestational age) up to 6 months
- •Admission at least 24 hours to PICU prior to intervention
- •Presence/availability of at least one parent/legal guardian
排除标准
- •Life threatening condition
- •Patients who cannot be positioned in supine position
- •Skin injury at body area in contact with support surface
- •Patients with congenital skin disorders
- •Patients with omphalocele or gastroschisis
- •Newborns with peripartum asphyxia and hypothermia therapy
- •Language communication difficulties with the legal guardians
- •Surgical patients on the day of surgery
- •birth weight <1250g
结局指标
主要结局
Interface pressure resulting from the exposure of patients to the supportive structures as measured by a pressure sensitive mat (xsensor, LX100:100.160.05, XSENSOR Technology Corporation, Calgary, Canada).
时间窗: after 60 minutes of exposure to the mattress
Quantification of interface pressure between the patient and the mattress surfaces with emphasis on data of highest pressures (median for top 25% of pressure data observed; 4th quartile of pressure data).
次要结局
- Skin assessment according to standard clinical procedure(baseline)
- Delirium assessment by means of the Cornell Assessment of Pediatric Delirium score (CAPD)(after 60 minutes of exposure to the mattress)
- Stress assessment by means of blood oxygen saturation(after 60 minutes of exposure to the mattress)
- Stress assessment by means of a visual analogue scale(after 60 minutes of exposure to the mattress)
- Skin perfusion assessment by means of capillary refill time(after 60 minutes of exposure to the mattress)
- Contact area resulting from the exposure of patients to the supportive structures as detected by a pressure sensitive mat (xsensor, LX100:100.160.05, XSENSOR Technology Corporation, Calgary, Canada)(after 60 minutes of exposure to the mattress)
- Stress assessment by means of respiratory rate(after 60 minutes of exposure to the mattress)
- Stress assessment by means of body temperature(after 60 minutes of exposure to the mattress)
- Skin assessment by means of questionnaire(after 60 minutes of exposure to the mattress)
- Comfort assessment by means of a visual analogue scale(after 60 minutes of exposure to the mattress)
- Unrest assessment by means of the Richmond Agitation-Sedation Scale (RASS) questionnaire(after 60 minutes of exposure to the mattress)
- Difference in stress assessment by means of heart rate(baseline)
- Stress assessment by means of heart rate(after 60 minutes of exposure to the mattress)
- Stress assessment by means of blood pressure (mean arterial pressure)(after 60 minutes of exposure to the mattress)
- Pain assessment by means of the questionnaire "Bern pain score for newborns - Revised (BSN-R)"(after 60 minutes of exposure to the mattress)
- Withdrawal assessment by means of the Sophia Observation Withdrawal Symptoms scale (SOS)(after 60 minutes of exposure to the mattress)
研究者
Simon Annaheim
Principle Investigator
Empa, Swiss Federal Laboratories for Materials Science and Technology
