Respiratory Distress Syndrome, AdultNCT03709199
Long Term Follow up of Children Enrolled in the REDvent Study
An observational study of Respiratory Distress Syndrome, Adult and Ventilator-Induced Lung Injury, run by Children's Hospital Los Angeles at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Respiratory Distress Syndrome, Adult, Ventilator-Induced Lung Injury, Neurocognitive Dysfunction
- What is being tested?
- Ventilation Inhomogeneity, Diaphragm Ultrasound and Respiratory Inductance Plethysmography
- How many people
- 176 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2018to 1 May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: This is a long term follow-up of children already enrolled in the RED-vent study.
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Los Angeles
Los Angeles, California, 90027
About this study
Official title: 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)
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).
Read more
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.
- Conditions
- Respiratory Distress Syndrome, Adult, Ventilator-Induced Lung Injury, Neurocognitive Dysfunction, Quality of Life, Respiration Disorders
- Being tested
- Ventilation Inhomogeneity, Diaphragm Ultrasound, Respiratory Inductance Plethysmography, Spirometry, Functional Residual Capacity
- Medical subject headings
- Respiratory Distress Syndrome, Ventilator-Induced Lung Injury, Cognition Disorders, Respiration Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ventilation InhomogeneityDiagnostic test
Also called Lung Clearance Index
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 UltrasoundDiagnostic test
Diaphragm thickness and contractile activity measured during tidal breathing.
Respiratory Inductance PlethysmographyDiagnostic test
Also called Phase Angle
Measure of thoraco-abdominal asynchrony during tidal breathing
SpirometryDiagnostic test
Also called Pulmonary Function Tests
Measurement of Forced Expiratory Volume (FEV1), Forced Vital Capacity and other lung volumes using standard pulmonary function techniques
Functional Residual CapacityDiagnostic test
Also called Pulmonary Function Tests
Measurement using body box plethysmography of functional residual capacity and other lung volumes using standard pulmonary function techniques
MIP/MEPDiagnostic test
Measurement of maximal inspiratory and expiratory pressures during airway occlusion
6 minute walk testDiagnostic test
Measurement of cardio-respiratory function and capabilities during treadmill walking for 6 minutes.
Neurocognitive TestingDiagnostic test
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 AssessmentDiagnostic test
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 LifeDiagnostic test
Also called PEDS-QL
Standardized instruments to assess (in person, over the phone, or via mail) health related quality of life in children. Parent and child questionnaires.
Functional StatusDiagnostic test
Also called Functional Status Scale
Survey of overall functional status, administrated by asking a series of questions to patient and families.
Respiratory Status QuestionnaireDiagnostic test
Survey of respiratory health, administrated by asking a series of questions to patient and families.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 3 months after ICU discharge
Secondary outcomes (46)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months after ICU discharge
Respiratory Muscle Strength Maximum inspiratory pressure (MIP)
Maximal inspiratory pressure measurements during airway occlusion in cm H20
Measured: 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
Measured: 6 months after ICU discharge
Respiratory Muscle Strength Maximum expiratory pressure (MEP)
Maximal expiratory pressure measurements during airway occlusion in cm H20
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: ICU discharge
Respiratory Status - questionnaire detailing respiratory medications and therapies as well as healthcare utilization.
Series of questions to detail respiratory based morbidity
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 12 months after ICU discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2018
- Study start1 Oct 2018
- Primary completion1 May 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Distress Syndrome, AdultStudies of the same condition, open and under way.
- More trials run by Children's Hospital Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robinder Khemani, Children's Hospital Los Angeles
- Investigators
- Robinder Khemani, MD, Principal investigator, Children's Hospital Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03709199
- Sponsor's protocol ID
- CHLA-18-00354
- Status last verified
- Apr 2025
- First submitted
- 30 Aug 2018
- Last updated
- 17 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share IPD with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT03709199
- Acronym / sponsor ID
- CHLA-18-00354
- Conditions
- Respiratory Distress Syndrome, Adult, Ventilator-Induced Lung Injury, Neurocognitive Dysfunction, Quality of Life, Respiration Disorders
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Children's Hospital Los AngelesUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 17 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- This is a long term follow-up of children already enrolled in the RED-vent study.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ventilation InhomogeneityAlso: Lung Clearance IndexVentilation 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. | Diagnostic test | – |
| Diaphragm UltrasoundDiaphragm thickness and contractile activity measured during tidal breathing. | Diagnostic test | – |
| Respiratory Inductance PlethysmographyAlso: Phase AngleMeasure of thoraco-abdominal asynchrony during tidal breathing | Diagnostic test | – |
| SpirometryAlso: Pulmonary Function TestsMeasurement of Forced Expiratory Volume (FEV1), Forced Vital Capacity and other lung volumes using standard pulmonary function techniques | Diagnostic test | – |
| Functional Residual CapacityAlso: Pulmonary Function TestsMeasurement using body box plethysmography of functional residual capacity and other lung volumes using standard pulmonary function techniques | Diagnostic test | – |
| MIP/MEPMeasurement of maximal inspiratory and expiratory pressures during airway occlusion | Diagnostic test | – |
| 6 minute walk testMeasurement of cardio-respiratory function and capabilities during treadmill walking for 6 minutes. | Diagnostic test | – |
| Neurocognitive TestingDetailed 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). | Diagnostic test | – |
| Emotional Health AssessmentIn 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. | Diagnostic test | – |
| Health Related Quality of LifeAlso: PEDS-QLStandardized instruments to assess (in person, over the phone, or via mail) health related quality of life in children. Parent and child questionnaires. | Diagnostic test | – |
| Functional StatusAlso: Functional Status ScaleSurvey of overall functional status, administrated by asking a series of questions to patient and families. | Diagnostic test | – |
| Respiratory Status QuestionnaireSurvey of respiratory health, administrated by asking a series of questions to patient and families. | Diagnostic test | – |
Primary outcome
Ventilation In-homogeneity using lung clearance index with nitrogen washout
Time frame: 6 months after ICU discharge
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.
Neurocognitive function using a standardized score derived from Batelle-2 or WISC-5 cognitive tests
Time frame: 3 months after ICU discharge
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
Health Related Quality of Life as measured by PedsQL generic core scale
Time frame: 3 months after ICU discharge
PedsQL generic core scale, with range from 0-100, with the higher score indicating better health related quality of life
Functional Status as measured by the pediatric functional status scale
Time frame: 3 months after ICU discharge
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.
46 secondary outcomes
Functional Residual Capacity (Lung volume at end-expiration).
Time frame: Prior to Hospital Discharge and no more than 1 month after ICU discharge
Functional Residual Capacity (Lung volume at end-expiration).
Time frame: 6 months after ICU discharge
Phase Angle (a measure of thoraco-abdominal asynchrony and abnormal respiratory mechanics)
Time frame: 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)
Time frame: 6 Months after ICU Discharge
Diaphragm Thickness on exhalation
Time frame: Prior to Hospital Discharge and no more than 1 month after ICU discharge
Diaphragm Thickness on exhalation
Time frame: 6 months after ICU discharge
Diaphragm Thickness on inspiration
Time frame: Prior to Hospital Discharge and no more than 1 month after ICU discharge
Diaphragm Thickness on inspiration
Time frame: 6 months after ICU discharge
Diaphragm Thickening fraction (measure of contractile activity)
Time frame: Prior to Hospital Discharge and no more than 1 month after ICU discharge
Diaphragm Thickening fraction (measure of contractile activity)
Time frame: 6 months after ICU discharge
Ventilation In-homogeneity using lung clearance index with nitrogen washout
Time frame: Prior to Hospital Discharge and no more than 1 month after ICU discharge
Forced Expiratory Volume in 1 second (FEV1)
Time frame: Prior to Hospital Discharge and no more than 1 month after ICU discharge
Forced Expiratory Volume in 1 second (FEV1)
Time frame: 6 months after ICU discharge
Forced Vital Capacity (FVC)
Time frame: Prior to Hospital Discharge and no more than 1 month after ICU discharge
Forced Vital Capacity (FVC)
Time frame: 6 months after ICU discharge
Forced expiratory flow at 25-75% (FEF 25-75)
Time frame: Prior to Hospital Discharge and no more than 1 month after ICU discharge
Forced expiratory flow at 25-75% (FEF 25-75)
Time frame: 6 months post ICU discharge
VT - tidal volume from spirometry during tidal breathing
Time frame: Prior to Hospital Discharge and no more than 1 month after ICU discharge
VT - tidal volume from spirometry during tidal breathing
Time frame: 6 months after ICU discharge
Total Lung Capacity- TLC measured during spirometry
Time frame: Prior to Hospital Discharge and no more than 1 month after ICU discharge
Total Lung Capacity- TLC measured during spirometry
Time frame: 6 months after ICU discharge
Forced vital capacity- measured during spirometry
Time frame: Prior to Hospital Discharge and no more than 1 month after ICU discharge
Forced vital capacity- measured during spirometry
Time frame: 6 months after ICU discharge
Respiratory Muscle Strength Maximum inspiratory pressure (MIP)
Time frame: Prior to Hospital Discharge and no more than 1 month after ICU discharge
Respiratory Muscle Strength Maximum inspiratory pressure (MIP)
Time frame: 6 months after ICU discharge
Respiratory Muscle Strength Maximum expiratory pressure (MEP)
Time frame: Prior to Hospital Discharge and no more than 1 month after ICU discharge
Respiratory Muscle Strength Maximum expiratory pressure (MEP)
Time frame: 6 months after ICU discharge
Neurocognitive function using a standardized score derived from Batelle-2 or WISC-5 cognitive tests
Time frame: 12 months after ICU discharge
Health Related Quality of Life as measured by PedsQL generic core scale
Time frame: ICU discharge
Health Related Quality of Life as measured by PedsQL generic core scale
Time frame: 1 month after ICU discharge
Health Related Quality of Life as measured by PedsQL generic core scale
Time frame: 2 months after ICU discharge
Health Related Quality of Life as measured by PedsQL generic core scale
Time frame: 6 months after ICU discharge
Health Related Quality of Life as measured by PedsQL generic core scale
Time frame: 12 months after ICU discharge
Functional Status as measured by the pediatric functional status scale
Time frame: ICU discharge
Functional Status as measured by the pediatric functional status scale
Time frame: 1 month after ICU discharge
Functional Status as measured by the pediatric functional status scale
Time frame: 2 months after ICU discharge
Functional Status as measured by the pediatric functional status scale
Time frame: 6 months after ICU discharge
Functional Status as measured by the pediatric functional status scale
Time frame: 12 months after ICU discharge
Respiratory Status - questionnaire detailing respiratory medications and therapies as well as healthcare utilization.
Time frame: ICU discharge
Respiratory Status - questionnaire detailing respiratory medications and therapies as well as healthcare utilization.
Time frame: 1 month after ICU discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2025.
- Individual participant dataSharing planned: No. There is no plan to share IPD with other researchers
Related trials for Respiratory Distress Syndrome, Adult
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
Not yet recruitingObservational study
Development and Multicenter Validation of an Explainable System for Neonatal ARDS-Compatible Phenotyping
Acute Respiratory Distress Syndrome
RecruitingObservational study
Assessment of Blood Viscosity in ARDS (Acute Respiratory Distress Syndrome)
ARDS
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robinder Khemani, MD principal investigator
Children's Hospital Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Distress Syndrome, Adult and Ventilator-Induced Lung Injury, run by Children's Hospital Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ventilation In-homogeneity using lung clearance index with nitrogen washout (time frame: 6 months after ICU discharge). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2025.