Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06400095
Status:
RECRUITING
Last Update Posted:
2024-05-06
First Post:
2024-04-25
Brief Title:
Ventilatory Parameters in Predicting Outcomes in ARDS Patients
Sponsor:
CentraCare
Organization:
CentraCare
Study Overview
Official Title:
Occlusion Pressure at 100 Msec TCe Expiratory Time Constant Stress Energy Density Mechanical Power Ventilatory Ratio and C20Cdyn in Predicting Outcomes in Patients With Moderately Severe ARDS Who Are on Mechanical Ventilation
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OCTANE
Brief Summary:
This is a single-centre prospective observational study aimed to determine if Pocc occlusion pressure at 100 msec TCe Expiratory time constant Mechanical Stress power Ventilatory ratio and C20Cdyn would predict outcomes in patients with moderately severe ARDS Acute respiratory distress syndrome who are on mechanical ventilation
Detailed Description:
Severe ARDS is characterized by significant lung heterogeneity with areas of collapse consolidation and normal lung parenchyma Institution of mechanical ventilation may result in Ventilation-induced lung injury because of significant heterogeneity with associated volutrauma atelectrauma and barotrauma
Underassistance results in persistent atelectasis and resultant diffusion abnormalities and over-assistance causes ventilator-associated lung injury
Mechanical power and driving pressure have been demonstrated to predict mortality in patients with Acute respiratory distress syndrome who are on mechanical ventilators Mechanical work is the energy delivered to the respiratory system during a single inspiratory cycle and is calculated by solving the integral of airway pressure to change in volume Mechanical power is work multiplied by RRRespiratory rate In the clinical setting various equations have been used to calculate mechanical power Mechanical Stress is defined as the internal distribution of force per unit area to an external load and associated deformation has been referred to as Strain Stress is derived from specific lung elastance Mechanical stress power is the power associated with internal forces required to maintain internal stresses within an object and is a part of mechanical power that is not converted to kinetic energy but rather into heat and change in internal energy
The time constant is a measure of respiratory mechanics and is calculated by the product of compliance and resistance Theoretically it is the time needed for the lungs to fill or be emptied at a stable pressure The expiratory time constant can indirectly represent lung heterogeneity during passive exhalation It has been proposed that a shorter expiratory time constant can lead to VILI and a longer time constant can lead to hyperinflation and auto-PEEP
The C20C Compliance 20overall compliance index measures the ratio of compliance of the last 20 of breath to the compliance of the entire breath It is believed that C20C 1 indicates tidal recruitment and C20C 1 indicates overinflation
Pulmonary dead space fraction VdVt is an independent predictor of mortality after adjusting for PF ratio and PEEP The ventilatory ratio has been proposed as a simplified bedside tool as a surrogate for the dead space ratio Ventilatory Ratio VR is defined as minute ventilation mlmin PaCO2Predicted body weight 100 375
For those patients who satisfy inclusion and exclusion criteria Day 1 will be considered as the the day of intubation Age gender Charleston co-morbidity index SOFA Sequential organ function assessment score at the time of intubation For day 1 to day 3 we shall record average values of Pocc TCe C20C index Ventilatory ratio Mechanical stress power and PF ratio PaO2FiO2 ratio will be recorded Outcome data such as the need for vasopressors prone position duration of ICU stay MAKE outcomes need for paralysis change in the mode of ventilator ventilator number of days hospital stay and 30-day outcomes including disability and survival
Statistical Analysis
Only de-identified data will be recorded on the spreadsheet
Baseline demographic features and descriptive clinical data will be summarized using means - SDs or medians with interquartile ranges IQR for continuous variables Percentages will be used for categorical variables For normally distributed data t test will be used to compare the two groups For skewed data or categorical data a non-parametric Mann-Whitney U test and Kruskal-Wallis test will be used For categorical data comparisons will be made using a Pearson or chi-square or the Fisher exact test as appropriate for more than two groups one-way ANOVA Analysis of variance will be employed The receiver operating characteristic approach will be used to identify the clinical significance of each of these variables Univariate analysis will be performed to identify predictors of outcomes If any factors are found significant data will be subjected to multivariate logistic regression analysis and the corresponding adjusted odds ratio will be calculated Pearson correlation and Bland-Altman analysis will be used as needed For all comparisons a p-value of 005 is considered significant Jamovi will be used for statistical analysis
Only de-identified data will be recorded on the spreadsheet
Underassistance results in persistent atelectasis and resultant diffusion abnormalities and over-assistance causes ventilator-associated lung injury
Mechanical power and driving pressure have been demonstrated to predict mortality in patients with Acute respiratory distress syndrome who are on mechanical ventilators Mechanical work is the energy delivered to the respiratory system during a single inspiratory cycle and is calculated by solving the integral of airway pressure to change in volume Mechanical power is work multiplied by RRRespiratory rate In the clinical setting various equations have been used to calculate mechanical power Mechanical Stress is defined as the internal distribution of force per unit area to an external load and associated deformation has been referred to as Strain Stress is derived from specific lung elastance Mechanical stress power is the power associated with internal forces required to maintain internal stresses within an object and is a part of mechanical power that is not converted to kinetic energy but rather into heat and change in internal energy
The time constant is a measure of respiratory mechanics and is calculated by the product of compliance and resistance Theoretically it is the time needed for the lungs to fill or be emptied at a stable pressure The expiratory time constant can indirectly represent lung heterogeneity during passive exhalation It has been proposed that a shorter expiratory time constant can lead to VILI and a longer time constant can lead to hyperinflation and auto-PEEP
The C20C Compliance 20overall compliance index measures the ratio of compliance of the last 20 of breath to the compliance of the entire breath It is believed that C20C 1 indicates tidal recruitment and C20C 1 indicates overinflation
Pulmonary dead space fraction VdVt is an independent predictor of mortality after adjusting for PF ratio and PEEP The ventilatory ratio has been proposed as a simplified bedside tool as a surrogate for the dead space ratio Ventilatory Ratio VR is defined as minute ventilation mlmin PaCO2Predicted body weight 100 375
For those patients who satisfy inclusion and exclusion criteria Day 1 will be considered as the the day of intubation Age gender Charleston co-morbidity index SOFA Sequential organ function assessment score at the time of intubation For day 1 to day 3 we shall record average values of Pocc TCe C20C index Ventilatory ratio Mechanical stress power and PF ratio PaO2FiO2 ratio will be recorded Outcome data such as the need for vasopressors prone position duration of ICU stay MAKE outcomes need for paralysis change in the mode of ventilator ventilator number of days hospital stay and 30-day outcomes including disability and survival
Statistical Analysis
Only de-identified data will be recorded on the spreadsheet
Baseline demographic features and descriptive clinical data will be summarized using means - SDs or medians with interquartile ranges IQR for continuous variables Percentages will be used for categorical variables For normally distributed data t test will be used to compare the two groups For skewed data or categorical data a non-parametric Mann-Whitney U test and Kruskal-Wallis test will be used For categorical data comparisons will be made using a Pearson or chi-square or the Fisher exact test as appropriate for more than two groups one-way ANOVA Analysis of variance will be employed The receiver operating characteristic approach will be used to identify the clinical significance of each of these variables Univariate analysis will be performed to identify predictors of outcomes If any factors are found significant data will be subjected to multivariate logistic regression analysis and the corresponding adjusted odds ratio will be calculated Pearson correlation and Bland-Altman analysis will be used as needed For all comparisons a p-value of 005 is considered significant Jamovi will be used for statistical analysis
Only de-identified data will be recorded on the spreadsheet
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None