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临床试验/NCT04748159
NCT04748159已完成不适用

Effekte Der Bauchlagerung Auf Die Vitalparameter Bei Säuglingen Mit Akuter Bronchiolitis (Masterarbeit EKNZ)

Luzerner Kantonsspital2 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2020年1月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
27
试验地点
2
主要终点
Change of the respiratory rate at 45-75 minutes

研究概览

简要总结

This intervention study is designed to evaluate short-term effects (within one hour) of prone position on vital signs in infants under 12 months of age with acute RSV bronchiolitis. The primary objective is to investigate whether respiratory rate changes in prone position. Secondary endpoints are changes in oxygen saturation (SpO2), transcutaneous carbon dioxide partial pressure (pCO2), heart rate, and respiratory symptoms assessed by the Modified Tal Score (MTS).

详细描述

The study will be conducted by pediatric physical therapists (PPT). Before the start of the study, the procedure of the study as well as the recording of the measurement data in the secuTrial® database, in the Excel file and the MTS will be explained to the PPT. The ward staff will be informed about the pilot study at an early stage in order to ensure a smooth procedure parallel to the clinic activities and to initiate a physiotherapy prescription for infants with acute bronchiolitis as quickly as possible. After new registration of a physical therapy prescription of an infant, the PPT in charge will obtain informed consent from the parent or legal guardian. Each study participant will be evaluated once and preferably at the beginning of the hospitalization. If the first trial is discontinued (see discontinuation criteria), a second trial will be conducted a few hours later. Because supine positioning is promoted to prevent sudden infant death syndrome, parents are informed that prone positioning is only a measure to speed recovery from the current RSV infection and that infants are monitored throughout data collection (pulse and oxygen saturation monitors). Parents will also be informed that prone positioning should not be performed at home without monitoring.

Prior to the start of the intervention, the PPT obtain the following personal data:

  • Date and time of hospital admission and physiotherapy prescription received.
  • Date of birth (DD.MM. YY), age (birthday to day of intervention), sex (m/f), gestational age (gestational week), birth weight (g), ethnicity (white/other), sectio (yes/no), secondary diagnoses, positive family history (first-degree relatives) for asthma (yes/no), positive family history (first-degree relatives) for allergies (yes/no), passive smoke exposure (yes/no), breastfed (yes/no/partial), care (home, nursery, other).
  • Evidence of other viruses (not tested; which virus), number of days since onset of symptoms, drug therapy, oxygen requirements, time of last feeding, type of feeding
  • Date and time of onset of intervention
  • Length of hospitalization (hospital admission to start of intervention)
  • Position of infant when encountered prior to start of intervention (supine, lateral right, lateral left, prone, being fed, on parent's arm or lap)

If infants require oxygen administration, it is documented as high flow or low flow with the associated percent of oxygen content and liters/minute. Furthermore, the first time of oxygen administration during the hospital stay (DD.MM.YY, HH:MM), the current cycle of oxygen administration (continuous or intermittent), and the duration of oxygen administration received will be recorded. During the more than one hour of data collection, the setting of oxygen administration will not be changed by the nursing staff. The nursing staff will be informed of this prior to the start of the study.

Next, the infant's position encountered will be noted and the first data collection of vital signs (baseline, T0) will be recorded. The infant is then positioned in the prone position in a standardized manner. One to two folded towels are placed lengthwise under the infant, depending on body size. Both arms are placed cranially in a U-position towards the head. The head is placed according to any tolerance of the infant. To initially acclimate the infants to the repositioning, reassurance techniques are used by the PPT. These are individualized to the infant and involve the head, chest, and pelvis regions of the body. The calming techniques consist of gentle mobilization of the pelvis, light touching and contact breathing. The latter elicits tactile stimuli by placing the PPT's hands on various areas of the thorax and can thereby target and direct the infant's respiratory movement. After one minute, a second data collection occurs, which is labeled T1. After T1, contact with the infant is avoided by the PPT until the next measurement time points (T2 + T3). No contact is allowed to other persons during the entire data collection unless an urgent nursing or medical action is necessary due to the infant's condition (see termination criteria). After an additional 9 minutes, measurement time point T2 (T0 + 10 minutes) is collected. The last data collection occurs 60 minutes (range 45-75 minutes) after T0 and is designated T3.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
0 Months 至 12 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Infants hospitalized due to RSV at the Lucerne Children's Hospital in the 2020 RSV season
  • Infants under twelve months with a mild to moderate severity of acute bronchiolitis
  • positive RSV Test: rapid antigen test or detection of nucleic acids by PCR in nasopharyngeal secretion

排除标准

  • Infants who are in a life-threatening condition and require intensive care

结局指标

主要结局

Change of the respiratory rate at 45-75 minutes

时间窗: Time 3 = Change from baseline at 45-75 minutes.

This parameter is determined first and by visual observation of the respective PPT. The breaths are counted in a period of one minute.

次要结局

  • Change of the respiratory rate at 1 minute(Time 1 = Change from baseline at 1 minute.)
  • Respiratory rate: Baseline(Time 0 = Collection of measurement data for the baseline. Repositioning of the child in prone position.)
  • Oxygen saturation (SpO2): Baseline(Time 0: Collection of measurement data for the baseline. Repositioning of the child in prone position.)
  • Change of oxygen saturation at 1 minute(Time 1 = Change from baseline at 1 minute.)
  • Change of oxygen saturation at 10 minutes(Time 2 = Change from baseline at 10 minutes.)
  • Change of oxygen saturation at 45-75 minutes(Time 3 = Change from baseline at 45-75 minutes.)
  • Transcutaneous carbon dioxide partial pressure (pCO2): Baseline(Time 0: Collection of measurement data for the baseline. Repositioning of the child in prone position.)
  • Change of transcutaneous carbon dioxide partial pressure at 45-75 minutes(Time 3 = Change from baseline at 45-75 minutes.)
  • Change of the respiratory rate at 10 minutes(Time 2 = Change from baseline at 10 minutes.)
  • Change of transcutaneous carbon dioxide partial pressure at 1 minute(Time 1 = Change from baseline at 1 minute.)
  • Change of transcutaneous carbon dioxide partial pressure at 10 minutes(Time 2 = Change from baseline at 10 minutes.)
  • Heart rate: Baseline(Time 0: Collection of measurement data for the baseline. Repositioning of the child in prone position.)
  • Change of the heart rate at 1 minute(Time 1 = Change from baseline at 1 minute.)
  • Change of the heart rate at 10 minutes(Time 2 = Change from baseline at 10 minutes.)
  • Change of the heart rate at 45-75 minutes(Time 3 = Change from baseline at 45-75 minutes.)
  • Symptom-Score - Modified Tal Score (MTS): Baseline(Time 0: Collection of measurement data for the baseline. Repositioning of the child in prone position.)
  • Symptom-Score MTS at 10 minutes(Time 2 = Change from baseline at 10 minutes.)
  • Symptom-Score - MTS at 1 minute(Time 1 = Change from baseline at 1 minute.)
  • Symptom-Score: MTS(Time 3 = Change from baseline at 45-75 minutes.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nicolas Regamey

Head of Paediatric Pulmonology

Luzerner Kantonsspital

研究点 (2)

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