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临床试验 NCT03709199 针对成人呼吸窘迫综合征，呼吸机引起的肺损伤，神经认知功能障碍，生活质量，呼吸障碍目前进行中但不再招募。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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Long Term Follow up of Children Enrolled in the REDvent Study
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临床试验NCT03709199是一项针对成人呼吸窘迫综合征，呼吸机引起的肺损伤，神经认知功能障碍，生活质量，呼吸障碍的观察研究试验，目前试验状态为进行中但不再招募。试验始于2018年10月1日，计划招募176名患者。该研究由Children's Hospital Los Angeles主导，预计于2026年5月1日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2025年4月17日。
简要概括
This is a prospective observational follow-up study of children enrolled in a single center randomized controlled trial (REDvent).
Nearly 50% of adult Acute Respiratory Distress Syndrome (ARDS) survivors are left with significant abnormalities in pulmonary, physical, neurocognitive function and Health Related Quality of Life (HRQL) which may persist for years.Data in pediatric ARDS (PARDS) survivors is limited. More importantly, there are no data identifying potentially modifiable factors during ICU care which are associated with long term impairments, which may include medication choices, or complications from mechanical ventilator (MV) management in the ICU including ventilator induced lung injury (VILI) or ventilator induced diaphragm dysfunction (VIDD).
The Real-time effort driven ventilator (REDvent) trial is testing a ventialtor management algorithm which may prevent VIDD and VILI. VIDD and VILI have strong biologic plausibility to affect the post-ICU health of children with likely sustained effects on lung repair and muscle strength. Moreover, common medication choices (i.e. neuromuscular blockade, corticosteroids) or other complications in the ICU (i.e. delirium) are likely to have independent effects on the long term health of these children. This proposed study will obtain serial follow-up of subjects enrolled in REDvent (intervention and control patients). The central hypothesis is that preventing VIDD, VILI and shortening time on MV will have a measureable impact on longer term function by mitigating abnormalities in pulmonary function (PFTs), neurocognitive function and emotional health, functional status and HRQL after hospital discharge for children with PARDS.
For all domains, the investigators will determine the frequency, severity and trajectory of recovery of abnormalities amongst PARDS survivors after ICU discharge, identify risk factors for their development, and determine if they are prevented by REDvent. They will leverage the detailed and study specific respiratory physiology data being obtained in REDvent, and use a variety of multi-variable models for comprehensive analysis. Completion of this study will enable the investigators to identify ICU related therapies associated with poor long term outcome, and determine whether they can be mitigated by REDvent.
官方标题
The Effect of Intensive Care Unit Therapies and Mechanical Ventilation Strategy on Long Term Outcome in Pediatric ARDS A Follow-up of the Real-time Effort Driven VENTilator Management Study (REDvent)
疾病
成人呼吸窘迫综合征呼吸机引起的肺损伤神经认知功能障碍生活质量呼吸障碍其他研究标识符
- CHLA-18-00354
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
不适用 | Ventilation Inhomogeneity Ventilation inhomogeneity will be measured using the Lung Clearance Index (LCI), derived from multiple breath Nitrogen washout during tidal breathing, measured by a mouthpiece or mask covering nose and mouth. Diaphragm Ultrasound Diaphragm thickness and contractile activity measured during tidal breathing. Respiratory Inductance Plethysmography Measure of thoraco-abdominal asynchrony during tidal breathing 肺活量测定 Measurement of Forced Expiratory Volume (FEV1), Forced Vital Capacity and other lung volumes using standard pulmonary function techniques Functional Residual Capacity Measurement using body box plethysmography of functional residual capacity and other lung volumes using standard pulmonary function techniques MIP/MEP Measurement of maximal inspiratory and expiratory pressures during airway occlusion 6分钟步行测试 Measurement of cardio-respiratory function and capabilities during treadmill walking for 6 minutes. 神经认知测试 Detailed in person neuro-cognitive testing using standardized inventories using either the Battelle Developmental Inventory, second edition (Battelle-2) (age birth to 5 years 11 months) and the Wechsler Intelligence Scale for Children, fifth edition (WISC-5, for age 6 years to 19 years). Emotional Health Assessment In person and written assessments of children and parents using the Behavioral Assessment System for Children, third edition (BASC-3) for children ≥ 2 years and the UCLA PTSD Reaction Index (UCLA RI) for children ≥ 8 years. Health Related Quality of Life Standardized instruments to assess (in person, over the phone, or via mail) health related quality of life in children. Parent and child questionnaires. Functional Status Survey of overall functional status, administrated by asking a series of questions to patient and families. Respiratory Status Questionnaire Survey of respiratory health, administrated by asking a series of questions to patient and families. |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Ventilation In-homogeneity using lung clearance index with nitrogen washout | Measured by lung clearance index during multiple breath nitrogen washout testing reported as percent predicted based on age and height as well as a raw number typically ranging from 5-15. | 6 months after ICU discharge |
Neurocognitive function using a standardized score derived from Batelle-2 or WISC-5 cognitive tests | Standardized IQ-like score derived from Batelle-2 or WISC-5 cognitive tests based on age. Children \< 6 years will receive the Batelle-2 and children \>=6 will receive the WISC-5. Overall score will be use for analysis with a higher value indicating better cognitive function. The range of "average" cognitive function lies between 90-109. Both tests are scored on the same scale | 3 months after ICU discharge |
Health Related Quality of Life as measured by PedsQL generic core scale | PedsQL generic core scale, with range from 0-100, with the higher score indicating better health related quality of life | 3 months after ICU discharge |
Functional Status as measured by the pediatric functional status scale | Functional status scale which is scored from normal (score =1) to very severe dysfunction (score =5) in each of 6 domains. The sum score of all domains will be used for analysis, yielding a minimum possible score of 6 and a maximum possible score of 30. Analysis will focus on a change in FSS from baseline (assessed as functional status 1 month prior to ICU admission). An increase in the FSS from baseline to 3 months will be considered as a decline in functional status. | 3 months after ICU discharge |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Functional Residual Capacity (Lung volume at end-expiration). | Measured by body box plethysmography and nitrogen washout techniques, normalized by age, height and gender. Values below or above normative values will be considered abnormal. | Prior to Hospital Discharge and no more than 1 month after ICU discharge |
Functional Residual Capacity (Lung volume at end-expiration). | Measured by body box plethysmography and nitrogen washout techniques, normalized by age, height and gender. Values below or above normative values will be considered abnormal. | 6 months after ICU discharge |
Phase Angle (a measure of thoraco-abdominal asynchrony and abnormal respiratory mechanics) | Respiratory Inductance Plethysmography belts are used during tidal breathing to measure thoraco-abdominal asyncrhony. Higher values will be considered abnormal with a range from 0-180. | Prior to Hospital Discharge and no more than 1 month after ICU discharge |
Phase Angle (a measure of thoraco-abdominal asynchrony and abnormal respiratory mechanics) | Respiratory Inductance Plethysmography belts are used during tidal breathing to measure thoraco-abdominal asyncrhony. Higher values will be considered abnormal with a range from 0-180. | 6 Months after ICU Discharge |
Diaphragm Thickness on exhalation | Diaphragm ultrasound measurement of thickness at end exhalation measured in zone of apposition of right hemi-diaphragm | Prior to Hospital Discharge and no more than 1 month after ICU discharge |
Diaphragm Thickness on exhalation | Diaphragm ultrasound measurement of thickness at end exhalation measured in zone of apposition of right hemi-diaphragm | 6 months after ICU discharge |
Diaphragm Thickness on inspiration | Diaphragm ultrasound measurement of thickness at end inspiration measured in zone of apposition of right hemi-diaphragm | Prior to Hospital Discharge and no more than 1 month after ICU discharge |
Diaphragm Thickness on inspiration | Diaphragm ultrasound measurement of thickness at end inspiration measured in zone of apposition of right hemi-diaphragm | 6 months after ICU discharge |
Diaphragm Thickening fraction (measure of contractile activity) | Diaphragm ultrasound measurement calculated as (thickness at end inspiration-thickness at end expiration)/(thickness at end expiration) measured in zone of apposition of right hemi-diaphragm. | Prior to Hospital Discharge and no more than 1 month after ICU discharge |
Diaphragm Thickening fraction (measure of contractile activity) | Diaphragm ultrasound measurement calculated as (thickness at end inspiration-thickness at end expiration)/(thickness at end expiration) measured in zone of apposition of right hemi-diaphragm. | 6 months after ICU discharge |
Ventilation In-homogeneity using lung clearance index with nitrogen washout | Measured by lung clearance index during multiple breath nitrogen washout testing reported as percent predicted based on age and height as well as a raw number typically ranging from 5-15. | Prior to Hospital Discharge and no more than 1 month after ICU discharge |
Forced Expiratory Volume in 1 second (FEV1) | Spirometry based measures of pulmonary function of forced expiratory volume, normalized based on age, height, and gender and reported as percent predicted. | Prior to Hospital Discharge and no more than 1 month after ICU discharge |
Forced Expiratory Volume in 1 second (FEV1) | Spirometry based measures of pulmonary function of forced expiratory volume, normalized based on age, height, and gender and reported as percent predicted. | 6 months after ICU discharge |
Forced Vital Capacity (FVC) | Spirometry based measures of pulmonary function of forced vital capacity, normalized based on age, height, and gender and reported as percent predicted. | Prior to Hospital Discharge and no more than 1 month after ICU discharge |
Forced Vital Capacity (FVC) | Spirometry based measures of pulmonary function of forced vital capacity, normalized based on age, height, and gender and reported as percent predicted. | 6 months after ICU discharge |
Forced expiratory flow at 25-75% (FEF 25-75) | Spirometry based measures of pulmonary function of forced expiratory flow at 25-75% of breath, normalized based on age, height, and gender and reported as percent predicted. | Prior to Hospital Discharge and no more than 1 month after ICU discharge |
Forced expiratory flow at 25-75% (FEF 25-75) | Spirometry based measures of pulmonary function of forced expiratory flow at 25-75% of breath, normalized based on age, height, and gender and reported as percent predicted. | 6 months post ICU discharge |
VT - tidal volume from spirometry during tidal breathing | Lung volume measurements obtained during tidal breathing, normalized in ml/kg ideal body weight. | Prior to Hospital Discharge and no more than 1 month after ICU discharge |
VT - tidal volume from spirometry during tidal breathing | Lung volume measurements obtained during tidal breathing, normalized in ml/kg ideal body weight. | 6 months after ICU discharge |
Total Lung Capacity- TLC measured during spirometry | Lung volume measurements obtained during pulmonary function tests with spirometry and body box plethysmography to calculate total lung capacity, normalized by age, height and gender. | Prior to Hospital Discharge and no more than 1 month after ICU discharge |
Total Lung Capacity- TLC measured during spirometry | Lung volume measurements obtained during pulmonary function tests with spirometry and body box plethysmography to calculate total lung capacity, normalized by age, height and gender. | 6 months after ICU discharge |
Forced vital capacity- measured during spirometry | Lung volume measurements obtained during pulmonary function tests with spirometry to calculate forced vital capacity, normalized by age, height and gender. | Prior to Hospital Discharge and no more than 1 month after ICU discharge |
Forced vital capacity- measured during spirometry | Lung volume measurements obtained during pulmonary function tests with spirometry to calculate forced vital capacity, normalized by age, height and gender. | 6 months after ICU discharge |
Respiratory Muscle Strength Maximum inspiratory pressure (MIP) | Maximal inspiratory pressure measurements during airway occlusion in cm H20 | Prior to Hospital Discharge and no more than 1 month after ICU discharge |
Respiratory Muscle Strength Maximum inspiratory pressure (MIP) | Maximal inspiratory pressure measurements during airway occlusion in cm H20 | 6 months after ICU discharge |
Respiratory Muscle Strength Maximum expiratory pressure (MEP) | Maximal expiratory pressure measurements during airway occlusion in cm H20 | Prior to Hospital Discharge and no more than 1 month after ICU discharge |
Respiratory Muscle Strength Maximum expiratory pressure (MEP) | Maximal expiratory pressure measurements during airway occlusion in cm H20 | 6 months after ICU discharge |
Neurocognitive function using a standardized score derived from Batelle-2 or WISC-5 cognitive tests | Standardized IQ-like score derived from Batelle-2 or WISC-5 cognitive tests. Overall score will be use for analysis with a higher value indicating better cognitive function. The range of "average" cognitive function lies between 90-109. | 12 months after ICU discharge |
Health Related Quality of Life as measured by PedsQL generic core scale | PedsQL generic core scale, with range from 0-100, with the higher score indicating better health related quality of life | ICU discharge |
Health Related Quality of Life as measured by PedsQL generic core scale | PedsQL generic core scale, with range from 0-100, with the higher score indicating better health related quality of life | 1 month after ICU discharge |
Health Related Quality of Life as measured by PedsQL generic core scale | PedsQL generic core scale, with range from 0-100, with the higher score indicating better health related quality of life | 2 months after ICU discharge |
Health Related Quality of Life as measured by PedsQL generic core scale | PedsQL generic core scale, with range from 0-100, with the higher score indicating better health related quality of life | 6 months after ICU discharge |
Health Related Quality of Life as measured by PedsQL generic core scale | PedsQL generic core scale, with range from 0-100, with the higher score indicating better health related quality of life | 12 months after ICU discharge |
Functional Status as measured by the pediatric functional status scale | Functional status scale which is scored from normal (score =1) to very severe dysfunction (score =5) in each of 6 domains. The sum score of all domains will be used for analysis, yielding a minimum possible score of 6 and a maximum possible score of 30. Analysis will focus on a change in FSS from baseline (assessed as functional status 1 month prior to ICU admission). An increase in the FSS from baseline will be considered as a decline in functional status. | ICU discharge |
Functional Status as measured by the pediatric functional status scale | Functional status scale which is scored from normal (score =1) to very severe dysfunction (score =5) in each of 6 domains. The sum score of all domains will be used for analysis, yielding a minimum possible score of 6 and a maximum possible score of 30. Analysis will focus on a change in FSS from baseline (assessed as functional status 1 month prior to ICU admission). An increase in the FSS from baseline will be considered as a decline in functional status. | 1 month after ICU discharge |
Functional Status as measured by the pediatric functional status scale | Functional status scale which is scored from normal (score =1) to very severe dysfunction (score =5) in each of 6 domains. The sum score of all domains will be used for analysis, yielding a minimum possible score of 6 and a maximum possible score of 30. Analysis will focus on a change in FSS from baseline (assessed as functional status 1 month prior to ICU admission). An increase in the FSS from baseline will be considered as a decline in functional status. | 2 months after ICU discharge |
Functional Status as measured by the pediatric functional status scale | Functional status scale which is scored from normal (score =1) to very severe dysfunction (score =5) in each of 6 domains. The sum score of all domains will be used for analysis, yielding a minimum possible score of 6 and a maximum possible score of 30. Analysis will focus on a change in FSS from baseline (assessed as functional status 1 month prior to ICU admission). An increase in the FSS from baseline will be considered as a decline in functional status. | 6 months after ICU discharge |
Functional Status as measured by the pediatric functional status scale | Functional status scale which is scored from normal (score =1) to very severe dysfunction (score =5) in each of 6 domains. The sum score of all domains will be used for analysis, yielding a minimum possible score of 6 and a maximum possible score of 30. Analysis will focus on a change in FSS from baseline (assessed as functional status 1 month prior to ICU admission). An increase in the FSS from baseline will be considered as a decline in functional status. | 12 months after ICU discharge |
Respiratory Status - questionnaire detailing respiratory medications and therapies as well as healthcare utilization. | Series of questions to detail respiratory based morbidity | ICU discharge |
Respiratory Status - questionnaire detailing respiratory medications and therapies as well as healthcare utilization. | Series of questions to detail respiratory based morbidity | 1 month after ICU discharge |
Respiratory Status - questionnaire detailing respiratory medications and therapies as well as healthcare utilization. | Series of questions to detail respiratory based morbidity | 2 months after ICU discharge |
Respiratory Status - questionnaire detailing respiratory medications and therapies as well as healthcare utilization. | Series of questions to detail respiratory based morbidity | 3 months after ICU discharge |
Respiratory Status - questionnaire detailing respiratory medications and therapies as well as healthcare utilization. | Series of questions to detail respiratory based morbidity | 6 months after ICU discharge |
Respiratory Status - questionnaire detailing respiratory medications and therapies as well as healthcare utilization. | Series of questions to detail respiratory based morbidity | 12 months after ICU discharge |
Emotional Health Outcomes using the (BASC-3) to assess emotional and behavioral abnormalities and UCLA Reaction Index to assess post traumatic stress | The Behavioral Assessment System for Children, third edition (BASC-3) for children ≥ 2 years will be used to assess for emotional and behavioral abnormalities as a survey tool. The UCLA PTSD Reaction Index (UCLA RI) will be used for children ≥ 8 years. The UCLA RI is a semi-structured interview assessing for exposure to traumatic events and PTS in children. | 3 months after ICU discharge |
Emotional Health Outcomes using the (BASC-3) to assess emotional and behavioral abnormalities and UCLA Reaction Index to assess post traumatic stress | The Behavioral Assessment System for Children, third edition (BASC-3) for children ≥ 2 years will be used to assess for emotional and behavioral abnormalities as a survey tool. The UCLA PTSD Reaction Index (UCLA RI) will be used for children ≥ 8 years. The UCLA RI is a semi-structured interview assessing for exposure to traumatic events and PTS in children. | 12 months after ICU discharge |
资格标准
适龄参与研究
儿童, 成人
最低年龄要求
1 Month
适龄性别
全部
- Children > 1 month (at least 44 weeks Corrected Gestational Age) and ≤ 18 years of age AND
- Supported on mechanical ventilation for pulmonary parenchymal disease (i.e., pneumonia, bronchiolitis, Pediatric Acute Respiratory Distress Syndrome (PARDS)) with Oxygen Saturation Index (OSI) ≥ 5 or Oxygenation Index (OI) ≥4 115 AND
- Who are within 48 hours of initiation of invasive mechanical ventilation (allow for up to 72 hours for those transferred from another institution) AND
- Enrolled in the REDvent Study
- Contraindications to use of an esophageal catheter (i.e. severe mucosal bleeding, nasal encephalocele, transphenoidal surgery) OR
- Contraindications to use of RIP bands (i.e. omphalocele, chest immobilizer or cast) OR
- Conditions precluding diaphragm ultrasound measurement (i.e. abdominal wall defects, pregnancy) OR
- Conditions precluding conventional methods of weaning (i.e., status asthmaticus, severe lower airway obstruction, critical airway, intracranial hypertension, Extra Corporeal Life Support (ECLS), intubation for UAO, tracheostomy, DNR, severe chronic respiratory failure, spinal cord injury above lumbar region, cyanotic heart disease (unrepaired or palliated)) OR
- Primary Attending physician refuses (will be cleared with primary attending before approaching the patient) OR
- Death in the ICU OR
- New DNR orders during acute illness in ICU OR
- Primary Language not English or Spanish OR
- Children in foster care or a ward of the state.
Children's Hospital Los Angeles研究责任方
Robinder Khemani, 主要研究者, Principal Investigator, Children's Hospital Los Angeles
没有联系数据。
1 位于 1 个国家/地区的研究中心
California
Children's Hospital Los Angeles, Los Angeles, California, 90027, United States