Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Other |
6 minute walk test |
Measure of cardio-respiratory function after treadmill walking |
Prior to Hospital Discharge and no more than 1 month after ICU discharge |
|
Other |
6 minute walk test |
Measure of cardio-respiratory function after treadmill walking |
6 months after ICU discharge |
|
Primary |
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 |
|
Primary |
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 |
|
Primary |
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 |
|
Primary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
Respiratory Muscle Strength Maximum inspiratory pressure (MIP) |
Maximal inspiratory pressure measurements during airway occlusion in cm H20 |
6 months after ICU discharge |
|
Secondary |
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 |
|
Secondary |
Respiratory Muscle Strength Maximum expiratory pressure (MEP) |
Maximal expiratory pressure measurements during airway occlusion in cm H20 |
6 months after ICU discharge |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
Respiratory Status - questionnaire detailing respiratory medications and therapies as well as healthcare utilization. |
Series of questions to detail respiratory based morbidity |
ICU discharge |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|