ARDSOCTANENCT06400095
Ventilatory Parameters in Predicting Outcomes in ARDS Patients
An observational study of ARDS and Mechanical Power, run by CentraCare at 1 site in United States.
Trial 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 C20/Cdyn would predict outcomes in patients with moderately severe ARDS (Acute respiratory distress syndrome), who are on… Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- ARDS, Mechanical Power
- What is being tested?
- Poccl, Time constant, driving pressure
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2023to Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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 score at the time of intubation. For day 1 to day 3, we shall record average values of Pocc, TCe, C20/C index, Ventilatory ratio, Mechanical stress power , PF ratio will be recorded. Outcome data such as need for vasopressors, prone position, duration of ICU stay, MAKE outcomes, need for paralysis, change in mode of ventilator, ventilator number of days, hospital stay and 30 days outcomes including disability and survival.
Who may be able to join
- Patients with Acute respiratory failure needing mechanical ventilation
- Diagnosis of Severe ARDS with severity: PF ratio < 150, with PEEP/CPAP > 5
Who cannot join
- r2 < 0.95, monitored on the ventilator
- Expiratory flow that is not first-order or non-exponential decay
- Patients with Nor-epinephrine requirements > 0.1 mcg/kg/min within 2 hours of intubation
- Patients requiring ECMO ( Extracorporeal membrane oxygenation)
- Patients with COPD or pulmonary fibrosis with a premorbid FEV1 < 1.5 L
- Severe atherosclerotic vascular disease
Show all 10Show fewer
- Patients with a chest tube, intra-abdominal hypertension or with its risk factors
- Patients with structural heart disease including pulmonary hypertension (RVSP > 45) and heart failure
- All comfort care orders in the ICU
- Patients who underwent tracheostomy
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
St Cloud Hospital
Saint Cloud, Minnesota, 56303
Ramakanth Pata, MD FCCP, 320-240-2207, cookybrey1@gmail.com
About this study
Official title: Occlusion Pressure at 100 Msec, TCe ( Expiratory Time Constant ), Stress Energy Density, Mechanical Power, Ventilatory Ratio and C20/Cdyn in Predicting Outcomes in Patients With Moderately Severe ARDS, Who Are on Mechanical Ventilation
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 C20/Cdyn would predict outcomes in patients with moderately severe ARDS (Acute respiratory distress syndrome), who are on mechanical ventilation
Read the 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 RR(Respiratory 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 C20/C (Compliance 20/overall compliance) index measures the ratio of compliance of the last 20% of breath to the compliance of the entire breath. It is believed that C20/C > 1 indicates tidal recruitment and C20/C < 1 indicates overinflation.
Pulmonary dead space fraction ( Vd/Vt) 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 ( ml/min) * PaCO2/Predicted body weight * 100* 37.5.
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, C20/C index, Ventilatory ratio, Mechanical stress power, and PF ratio (PaO2/FiO2 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 < 0.05 is considered significant. Jamovi will be used for statistical analysis.
Only de-identified data will be recorded on the spreadsheet
- Conditions
- ARDS, Mechanical Power
- Being tested
- Poccl, Time constant, driving pressure
- Keywords
- Expiratory time constant, Ventilator ratio, Cdyn/C20, Occlusion pressure at 100 msec
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Poccl, Time constant, driving pressureDiagnostic test
Also called mechanical power
Ventilatory parameters
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival or mortality
We will assess whether the patient would survive or not
Measured: From the date of enrollment to 90 days from enrolment or date of death, whichever came first, assessed up to 90 days.
Secondary outcomes (2)
MAKE ( Major adverse kidney events)
Will assess the need for dialysis or any evidence of acute kidney injury
Measured: From the date of enrollment to 90 days from enrolment or date of death, whichever came first, assessed up to 90 days.
ICU and Hospital length of stay
we shall assess the duration of patients stay in the ICU and in the hospital
Measured: From the date of enrollment to the number of days in ICU and in the hospital until discharge or date of death whichever came first, assessed up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2024
- Study start1 Jun 2023
- Primary completionJul 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ARDSStudies of the same condition, open and under way.
- 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CentraCare
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ramakanth Pata, CentraCare
- Investigators
- Ramakanth Pata, MD FCCP, Principal investigator, Centracare health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06400095
- Sponsor's protocol ID
- RAMOCTANE
- Acronym
- OCTANE
- Status last verified
- Aug 2024
- First submitted
- 25 Apr 2024
- Last updated
- 22 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Paudel R, Trinkle CA, Waters CM, Robinson LE, Cassity E, Sturgill JL, Broaddus R, Morris PE. Mechanical Power: A New Concept in Mechanical Ventilation. Am J Med Sci. 2021 Dec;362(6):537-545. doi: 10.1016/j.amjms.2021.09.004. Epub 2021 Sep 28.
PubMed 34597688Guttmann J, Eberhard L, Fabry B, Bertschmann W, Zeravik J, Adolph M, Eckart J, Wolff G. Time constant/volume relationship of passive expiration in mechanically ventilated ARDS patients. Eur Respir J. 1995 Jan;8(1):114-20. doi: 10.1183/09031936.95.08010114.
PubMed 7744177
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Occlusion Pressure at 100 Msec, TCe ( Expiratory Time Constant ), Stress Energy Density, Mechanical Power, Ventilatory Ratio and C20/Cdyn in Predicting Outcomes in Patients With Moderately Severe ARDS, Who Are on Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT06400095
- Acronym / sponsor ID
- OCTANE / RAMOCTANE
- Conditions
- ARDS, Mechanical Power
- Keywords
- Expiratory time constant, Ventilator ratio, Cdyn/C20, Occlusion pressure at 100 msec
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- CentraCareUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 6 May 2024 (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 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 C20/Cdyn 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 RR(Respiratory 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 C20/C (Compliance 20/overall compliance) index measures the ratio of compliance of the last 20% of breath to the compliance of the entire breath. It is believed that C20/C > 1 indicates tidal recruitment and C20/C < 1 indicates overinflation.
Pulmonary dead space fraction ( Vd/Vt) 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 ( ml/min) * PaCO2/Predicted body weight * 100* 37.5.
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, C20/C index, Ventilatory ratio, Mechanical stress power, and PF ratio (PaO2/FiO2 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 < 0.05 is considered significant. Jamovi will be used for statistical analysis.
Only de-identified data will be recorded on the spreadsheet
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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 score at the time of intubation. For day 1 to day 3, we shall record average values of Pocc, TCe, C20/C index, Ventilatory ratio, Mechanical stress power , PF ratio will be recorded. Outcome data such as need for vasopressors, prone position, duration of ICU stay, MAKE outcomes, need for paralysis, change in mode of ventilator, ventilator number of days, hospital stay and 30 days outcomes including disability and survival.
Key inclusion criteria (2 listed)
- Patients with Acute respiratory failure needing mechanical ventilation
- Diagnosis of Severe ARDS with severity: PF ratio < 150, with PEEP/CPAP > 5
Key exclusion criteria (10 listed)
- r2 < 0.95, monitored on the ventilator
- Expiratory flow that is not first-order or non-exponential decay
- Patients with Nor-epinephrine requirements > 0.1 mcg/kg/min within 2 hours of intubation
- Patients requiring ECMO ( Extracorporeal membrane oxygenation)
- Patients with COPD or pulmonary fibrosis with a premorbid FEV1 < 1.5 L
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 |
|---|---|---|
| Poccl, Time constant, driving pressureAlso: mechanical powerVentilatory parameters | Diagnostic test | – |
Primary outcome
Survival or mortality
Time frame: From the date of enrollment to 90 days from enrolment or date of death, whichever came first, assessed up to 90 days.
We will assess whether the patient would survive or not
2 secondary outcomes
MAKE ( Major adverse kidney events)
Time frame: From the date of enrollment to 90 days from enrolment or date of death, whichever came first, assessed up to 90 days.
ICU and Hospital length of stay
Time frame: From the date of enrollment to the number of days in ICU and in the hospital until discharge or date of death whichever came first, assessed up to 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2024.
- Background: PubMed 34597688Paudel R, Trinkle CA, Waters CM, Robinson LE, Cassity E, Sturgill JL, Broaddus R, Morris PE. Mechanical Power: A New Concept in Mechanical Ventilation. Am J Med Sci. 2021 Dec;362(6):537-545. doi: 10.1016/j.amjms.2021.09.004. Epub 2021 Sep 28.
- Background: PubMed 7744177Guttmann J, Eberhard L, Fabry B, Bertschmann W, Zeravik J, Adolph M, Eckart J, Wolff G. Time constant/volume relationship of passive expiration in mechanically ventilated ARDS patients. Eur Respir J. 1995 Jan;8(1):114-20. doi: 10.1183/09031936.95.08010114.
- Individual participant dataSharing planned: Undecided
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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.
Ramakanth Pata, MD FCCP principal investigator
Centracare health System
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 ARDS and Mechanical Power, run by CentraCare 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 2 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 22 Aug 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ramakanth Pata, MD FCCP (320-240-2207, cookybrey1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival or mortality (time frame: From the date of enrollment to 90 days from enrolment or date of death, whichever came first, assessed up to 90 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06400095, which also lists 2 linked publications.
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 22 Aug 2024.