Point of Care Lung Ultrasound to Differentiate Causes of Respiratory Distress in Children With Severe Malaria
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Proportion of children diagnoses
研究概览
简要总结
A prospective cohort study, with 171 children admitted for severe malaria that will be included in the cohort. The study will take place in Kinshasa, Democratic Republic of Congo.
The primary objective is to evaluate the prevalence of five pre-specified pulmonary diagnoses that can be facilitated by the use of LUS (normal lung or acidotic breathing, ARDS, concomitant pneumonia, hydrostatic pulmonary oedema, pleural effusion).
详细描述
A prospective cohort study, with 171 children (between 1 - 14 years) admitted for severe malaria that will be included in the cohort. The study will take place at the Maluku District Hospital, located in Kinshasa, Democratic Republic of Congo.
Lung ultrasound will be performed on admission, h24, and unscheduled timepoints (in case of respiratory deterioration during hospital stay). Lung auscultation and peripheral capillary oxygen saturation (SpO2) will be assessed at each time points. All children will be observed from admission to hospital discharge. At 30 days a phone call will be made by the study staff to follow up clinical conditions of the child.
The total duration for each subject's participation in the study is approximately 1 month. The study period is approximately 12 months
Funder: The Wellcome Trust (ITPA grant) WT-iTP-2019/005
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Year 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged between 1 and 14 years;
- •Admitted for confirmed severe malaria (i.e. positive peripheral blood slide for malaria parasite and/or positive rapid diagnostic test for malaria in combination with one or more clinical or laboratory severity criteria detailed below).
- •Informed consent signed
- •Clinical features of severe malaria
- •Cerebral malaria; A Glasgow Coma Scale of less than 11 or a Blantyre coma scale less than 3 in preverbal children
- •Respiratory distress (costal indrawing, use of accessory muscles, nasal flaring, deep breathing or severe tachypnea (respiratory rate > upper normal limit for age)
- •Jaundice (visible jaundice)
- •Circulatory collapse or shock: age <12 systolic blood pressure < 70mm Hg; age > 12 systolic blood pressure <80mm Hg with cool extremities or capillary refill time >3 seconds
- •Spontaneous bleeding
- •Multiple generalized convulsions: more than two episodes within 24h
- •Prostration, i.e. generalized weakness so that the patient is unable to sit, stand or walk without assistance
- •Laboratory features and other findings
- •Metabolic acidosis (venous plasma bicarbonate < 15mmol/l or base excess < -2.2mEq/L)
- •Severe anaemia (age <12: hematocrit < 15% or haemoglobin < 5g/dl; age>12: hematocrit < 20% or hemoglobin < 7 g /dl)
- •Hypoglycaemia (< 2.2mmol/l or < 40mg/dl)
- •Hyperparasitaemia defined as > 10%
- •Hyperlactataemia (venous lactate < 5 mmol/L)
- •Kidney dysfunction (blood urea >20mmol/L)
排除标准
- •Co-morbidity which, in the judgement of the investigator or treating physician, would place the subject at undue risk or interfere with the patient's treatment or results of the study. E.g. immediate transfer needed.
结局指标
主要结局
Proportion of children diagnoses
时间窗: On the day of hospital admission
Proportion of children diagnosed with (1) respiratory distress with normal lungs (acidosis) in the first 6 hours after hospital admission, (2) concomitant pneumonia, (3) hydrostatic pulmonary oedema, (4) pleural effusion and (5) acute respiratory distress syndrome (ARDS).
次要结局
- Median lung ultrasound score(On the day of hospital admission)
- Proportion of children that fulfill the criteria for a new pulmonary diagnosis >6 hours from admission.(From admission to discharge, aproximately 1 week)
- Percentage agreement between a positive lung auscultation (bilateral crepitations) and a lung ultrasound consistent with pulmonary oedema.(From hospital admission to discharge, aproximately 1 week)
- Hospital mortality and 30 days mortality(On hospital discharge, maximum 30 days after admission to hospital)