ARDS, HumanNCT04419376
Driving Pressure and Mortality: in the Pediatric Intensive Care Unit (PICU)
An observational study of ARDS, Human and Respiratory Failure, run by Dr. Behcet Uz Children's Hospital at 1 site in Turkey (Türkiye).
Trial summary
Respiratory failure is one of the most common causes of both hospitalization and mortality in patients in the pediatric intensive care unit (PICU). Recently, it is recommended to target driving pressure (ΔP) in patients with ARDS to achieve better results with the administration of optimal mechanical ventilation. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- ARDS, Human, Respiratory Failure
- What is being tested?
- driving pressure
- Type of treatment
- Medical device
- How many people
- 116 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Mar 2018to 15 Apr 2020
- How long will I take part?
- 30 Days
- 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 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: In our study, patients who received invasive mechanical ventilation support due to respiratory failure in the pediatric intensive care unit over 1 month and under 18 years were included in the study between March 2018 and April 2020. Mechanically ventilated patients (via ETT or trachestomy) were recorded for patients whose ventilation duration lasted at least 24 hours. We divided the patients into two groups by calculating the oxygenation index (OI): [mean airway pressure(MAP) × fraction of inspired oxygen (FiO2) ]/ partial pressure of oxygen in arterial blood (PaO2) × 100) used in the classification of PALICC, including ARDS and non-ARDS.
Who may be able to join
- In our study, patients who received invasive mechanical ventilation support for at least 24 hours due to respiratory failure in the pediatric intensive care unit over 1 month and under 18 years were included in the study between March 2018 and April 2020.
Who cannot join
- patients who died within the first 24 hours and patients whose desired respiratory mechanics were not measured and data deficiencies were detected
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
The Health Sciences University Izmir Behçet Uz Child Health and Diseases education and research hospital
Izmir, Turkey/izmir, 35200
About this study
Respiratory failure is one of the most common causes of both hospitalization and mortality in patients in the pediatric intensive care unit (PICU). Recently, it is recommended to target driving pressure (ΔP) in patients with ARDS to achieve better results with the administration of optimal mechanical ventilation. In many studies, higher ΔP was associated with mortality in adult ARDS patients; non-ARDS patients' studies showing the relationship between driving pressure and mortality are few, but contradictory results have come out.
This study aimed to determine whether ΔP was associated with mortality in pediatric patients diagnosed as pARDS and non-pARDS who received mechanical ventilation support due to respiratory failure. Patients who received invasive mechanical ventilation support due to respiratory failure in the pediatric intensive care unit over 1 month and under 18 years were included in our study Driving pressure was significantly associated with an increased risk of mortality among mechanically ventilated both pARDS and non-pARDS patients. Future prospective randomized clinical trials are needed to determine a protocol targeting DP can be developed and defining optimum cutoff values.
Read the detailed description
Respiratory failure is one of the most common causes of both hospitalization and mortality in patients in the pediatric intensive care unit (PICU). Recently, it is recommended to target driving pressure (ΔP) in patients with ARDS to achieve better results with the administration of optimal mechanical ventilation. ΔP is calculated as the difference between Plateau pressure (Pplat) and positive end-expiratory pressure (PEEP) and is determined by the ratio of the tidal volume to the compliance of the respiratory system (ΔP = Pplat - PEEP = VT/CRS). ΔP estimates how much mechanical strain (dynamic strain) the tidal volume causes in the lung. It is a non-invasive and simple method and can be easily calculated at the bedside. In many studies, higher ΔP was associated with mortality in adult ARDS patients; non-ARDS patients' studies showing the relationship between driving pressure and mortality are few, but contradictory results have come out.
This study aimed to determine whether ΔP was associated with mortality in pediatric patients diagnosed as pARDS and non-pARDS who received mechanical ventilation support due to respiratory failure.
Single-center, prospective, observational study of patients admitted to pediatric intensive care units (PICU) in Turkey. In our study, the ethics committee was approved by The Health Sciences University Izmir Behcet Uz Child Health and Diseases education and research hospital ethics committee (protocol no: 2019-344).In our study, patients who received invasive mechanical ventilation support due to respiratory failure in the pediatric intensive care unit over 1 month and under 18 years were included in the study between March 2018 and April 2020. Mechanically ventilated patients (via ETT or trachestomy) were recorded for patients whose ventilation duration lasted at least 24 hours. We divided the patients into two groups by calculating the oxygenation index (OI): [mean airway pressure(MAP) × fraction of inspired oxygen (FiO2) ]/ partial pressure of oxygen in arterial blood (PaO2) × 100) used in the classification of PALICC, including ARDS and non-ARDS. PARDS definition was also identified based on the PALICC criteria. Data were prospectively recorded on day 1 including patient demographics, ventilator settings (VT, VT / ideal body weight (IBW), respiratory rate (RR), peak inspiratory pressure (PIP), plateau pressure (Pplat), mean airway pressure (Pmean), minute volume (VE), end-expiratory pressure (PEEP), static compliance (Cstat), fraction of inspired oxygen FIO2, inspiratory time ( IT), expiratory time (ET) and we calculated oxygenation index (OI), cstat (VT/∆P), partial pressure of oxygen in arterial blood (PaO2) /FiO2, driving pressure (ΔP), the pediatric index of mortality (PRISM) III scores and pediatric sequential organ failure assessment (pSOFA) scores.
All patients were ventilated with volume control (VCV) or pressure control (PCV) mode during the hospitalization. İn order to measure the driving pressure of patients, Pplat was measured in the mechanical ventilator every 12 hours using an inspiratory hold maneuver. The average Pplat was calculated using the mean of 2 measurements within 24 hours. Then, the total PEEP was measured by expiratory hold maneuver and ΔP was calculated with the Pplat-PEEP formula. Patients were followed for 30 days until hospital discharge. We used ΔP compared to other mechanic ventilator parameters between survivors and non-survivors at day 30. Besides, ΔP and other parameters of patients in the ARDS and non-ARDS groups were compared with their 30-day mortality.
Statistical Analyses Primarily, we evaluated the relationship between ΔP and mortality in patients with ARDS and non-ARDS. Our second target was to evaluate the relationship between mortality and ΔP and other mechanical ventilator parameters.
Driving pressure and other lung dynamics; according to the type and distribution of the data was compared with chi-square, Wilcoxon, Independent-T-test or Mann-Whitney-U test and p <0.05 was considered statistically significant. The strength of the association between the two variables was measured using the correlation coefficient. We used Pearson correlation to parametric variable and Spearman correlation to the nonparametric variable to detect covariances before logistic regression analysis. We evaluated with spearman's correlation analysis to detect covariances before logistic regression analysis. Parameters found significant with mortality in univariate analyzes were evaluated by Logistic Regression analysis. (odds ratio [OR] and 95 % confidence intervals [CI]) Model fit was assessed using Hosmer-Lemeshow statistics.
For the multivariable analysis, we identified covariates that may be associated with mortality. VT /IBW, PaO2, OI, FiO2, PRISM III score, Days of ventilation and pSOFA score were not collinear with ΔP. We did not include Pplat, PIP, Pmean in logistic regression models containing ΔP given concerns for collinearity Individual covariates included age, gender, PRISM III score, PaO2, OI, FiO2, Days of ventilation and pSOFA score. We created 3 other modeling analyzes for Pplat, PIP, Pmean, because of collinearity with driving pressure. We evaluated this model to determine the best parameter related to mortality in whole patients under mechanical ventilation support due to respiratory failure. ΔP cut off (13 cmH2O) values in adult studies in the literature were categorized and mortality was estimated by a receiver operating characteristic (ROC). We performed all statistical analyses using IBM SPSS Statistics for Windows version 22 (Armonk, NY) for analysis.
Mechanical ventilation is one of the most common indications for admission to a pediatric intensive care unit (PICU), with up to 64% of admitted children requiring mechanical ventilation. Driving pressure (ΔP), which is calculated as end-inspiratory plateau pressure (Pplat) minus applied positive end-expiratory pressure (PEEP) and is equivalent to the ratio between the VT and compliance of the respiratory system, can reduce mortality with children who received mechanical ventilator support due to respiratory failure. ΔP is a non-invasive and simple method and can be easily calculated at the bedside.
Recent data in the adult ARDS population have shown that the ΔP is most related to mortality. Our study, we have shown that the ΔP on day 1 was associated with hospital mortality in with pARDS patients.
- Conditions
- ARDS, Human, Respiratory Failure
- Being tested
- driving pressure
- Keywords
- Driving pressure, mortality, Pediatric intensive care unit, Pediatric acute respiratory distress syndrome
- Medical subject headings
- Respiratory Distress Syndrome, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
driving pressureDevice
Mechanically ventilated patients (via ETT or trachestomy) were recorded for patients whose ventilation duration lasted at least 24 hours.We divided the patients into two groups by calculating the oxygenation index (OI): [mean airway pressure(MAP) × fraction of inspired oxygen (FiO2) ]/ partial pressure of oxygen in arterial blood (PaO2) × 100) used in the classification of PALICC, including pARDS and non-pARDS.
| Study group | Role | What they receive |
|---|---|---|
| Patients with pARDS | Within 7 days of known clinical insult Respiratory failure not fully explained by cardiac failure or fluid overload chest imaging findings of new infiltrate(s) consistent with acute pulmonary parenchymal disease patients with an oxygenation index (OI) ([FIO2 × mean airway pressure × 100]/PaO2) above 4 Receives: Device: driving pressure | |
| Patients with non-pARDS | non-pARDS patients who received mechanical ventilation support due to respiratory failure. Receives: Device: driving pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Driving pressure and mortality with all patients
Driving pressure and other lung dynamics; according to the type and distribution of the data was compared with chi-square, Wilcoxon, Independent-T-test or Mann-Whitney-U test and p <0.05 was considered statistically significant.
Measured: march 2018-april 2020
Secondary outcomes (1)
Driving pressure with mortality in patients with pARDS and non-pARDS patients
we conducted separately to determine the relationship between ΔP and mortality in patients non-ARDS and ARDS
Measured: march 2018-april 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2020
- Study start30 Mar 2018
- Primary completion1 Apr 2020
- Study completion15 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for ARDS, HumanStudies 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
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 116 participants (actual)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Dr. Behcet Uz Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ekin soydan, Dr. Behcet Uz Children's Hospital
- Investigators
- ekin soydan, Principal investigator, Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04419376
- Sponsor's protocol ID
- 2019-344
- Status last verified
- Jun 2020
- First submitted
- 1 Jun 2020
- Last updated
- 5 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: we will share our data in the future
Publications
Ferguson ND, Fan E, Camporota L, Antonelli M, Anzueto A, Beale R, Brochard L, Brower R, Esteban A, Gattinoni L, Rhodes A, Slutsky AS, Vincent JL, Rubenfeld GD, Thompson BT, Ranieri VM. The Berlin definition of ARDS: an expanded rationale, justification, and supplementary material. Intensive Care Med. 2012 Oct;38(10):1573-82. doi: 10.1007/s00134-012-2682-1. Epub 2012 Aug 25.
PubMed 22926653Santschi M, Jouvet P, Leclerc F, Gauvin F, Newth CJ, Carroll CL, Flori H, Tasker RC, Rimensberger PC, Randolph AG; PALIVE Investigators; Pediatric Acute Lung Injury and Sepsis Investigators Network (PALISI); European Society of Pediatric and Neonatal Intensive Care (ESPNIC). Acute lung injury in children: therapeutic practice and feasibility of international clinical trials. Pediatr Crit Care Med. 2010 Nov;11(6):681-9. doi: 10.1097/PCC.0b013e3181d904c0.
PubMed 20228688Pediatric Acute Lung Injury Consensus Conference Group. Pediatric acute respiratory distress syndrome: consensus recommendations from the Pediatric Acute Lung Injury Consensus Conference. Pediatr Crit Care Med. 2015 Jun;16(5):428-39. doi: 10.1097/PCC.0000000000000350.
PubMed 25647235Kneyber MCJ, de Luca D, Calderini E, Jarreau PH, Javouhey E, Lopez-Herce J, Hammer J, Macrae D, Markhorst DG, Medina A, Pons-Odena M, Racca F, Wolf G, Biban P, Brierley J, Rimensberger PC; section Respiratory Failure of the European Society for Paediatric and Neonatal Intensive Care. Recommendations for mechanical ventilation of critically ill children from the Paediatric Mechanical Ventilation Consensus Conference (PEMVECC). Intensive Care Med. 2017 Dec;43(12):1764-1780. doi: 10.1007/s00134-017-4920-z. Epub 2017 Sep 22.
PubMed 28936698Acute Respiratory Distress Syndrome Network; Brower RG, Matthay MA, Morris A, Schoenfeld D, Thompson BT, Wheeler A. Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med. 2000 May 4;342(18):1301-8. doi: 10.1056/NEJM200005043421801.
PubMed 10793162Slutsky AS, Ranieri VM. Ventilator-induced lung injury. N Engl J Med. 2013 Nov 28;369(22):2126-36. doi: 10.1056/NEJMra1208707. No abstract available.
PubMed 24283226Guo L, Xie J, Huang Y, Pan C, Yang Y, Qiu H, Liu L. Higher PEEP improves outcomes in ARDS patients with clinically objective positive oxygenation response to PEEP: a systematic review and meta-analysis. BMC Anesthesiol. 2018 Nov 17;18(1):172. doi: 10.1186/s12871-018-0631-4.
PubMed 30447683Khemani RG, Conti D, Alonzo TA, Bart RD 3rd, Newth CJ. Effect of tidal volume in children with acute hypoxemic respiratory failure. Intensive Care Med. 2009 Aug;35(8):1428-37. doi: 10.1007/s00134-009-1527-z. Epub 2009 Jun 17.
PubMed 19533092Briel M, Meade M, Mercat A, Brower RG, Talmor D, Walter SD, Slutsky AS, Pullenayegum E, Zhou Q, Cook D, Brochard L, Richard JC, Lamontagne F, Bhatnagar N, Stewart TE, Guyatt G. Higher vs lower positive end-expiratory pressure in patients with acute lung injury and acute respiratory distress syndrome: systematic review and meta-analysis. JAMA. 2010 Mar 3;303(9):865-73. doi: 10.1001/jama.2010.218.
PubMed 20197533Amato MB, Meade MO, Slutsky AS, Brochard L, Costa EL, Schoenfeld DA, Stewart TE, Briel M, Talmor D, Mercat A, Richard JC, Carvalho CR, Brower RG. Driving pressure and survival in the acute respiratory distress syndrome. N Engl J Med. 2015 Feb 19;372(8):747-55. doi: 10.1056/NEJMsa1410639.
PubMed 25693014Aoyama H, Pettenuzzo T, Aoyama K, Pinto R, Englesakis M, Fan E. Association of Driving Pressure With Mortality Among Ventilated Patients With Acute Respiratory Distress Syndrome: A Systematic Review and Meta-Analysis. Crit Care Med. 2018 Feb;46(2):300-306. doi: 10.1097/CCM.0000000000002838.
PubMed 29135500Chen Z, Wei X, Liu G, Tai Q, Zheng D, Xie W, Chen L, Wang G, Sun JQ, Wang S, Liu N, Lv H, Zuo L. Higher vs. Lower DP for Ventilated Patients with Acute Respiratory Distress Syndrome: A Systematic Review and Meta-Analysis. Emerg Med Int. 2019 Jul 18;2019:4654705. doi: 10.1155/2019/4654705. eCollection 2019.
PubMed 31396419Guerin C, Papazian L, Reignier J, Ayzac L, Loundou A, Forel JM; investigators of the Acurasys and Proseva trials. Effect of driving pressure on mortality in ARDS patients during lung protective mechanical ventilation in two randomized controlled trials. Crit Care. 2016 Nov 29;20(1):384. doi: 10.1186/s13054-016-1556-2.
PubMed 27894328Lanspa MJ, Peltan ID, Jacobs JR, Sorensen JS, Carpenter L, Ferraro JP, Brown SM, Berry JG, Srivastava R, Grissom CK. Driving pressure is not associated with mortality in mechanically ventilated patients without ARDS. Crit Care. 2019 Dec 27;23(1):424. doi: 10.1186/s13054-019-2698-9.
PubMed 31881909Serpa Neto A, Cardoso SO, Manetta JA, Pereira VG, Esposito DC, Pasqualucci Mde O, Damasceno MC, Schultz MJ. Association between use of lung-protective ventilation with lower tidal volumes and clinical outcomes among patients without acute respiratory distress syndrome: a meta-analysis. JAMA. 2012 Oct 24;308(16):1651-9. doi: 10.1001/jama.2012.13730.
PubMed 23093163
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Driving Pressure and Mortality: in the Pediatric Intensive Care Unit (PICU)
- ClinicalTrials.gov ID
- NCT04419376
- Acronym / sponsor ID
- 2019-344
- Conditions
- ARDS, Human, Respiratory Failure
- Keywords
- Driving pressure, mortality, Pediatric intensive care unit, Pediatric acute respiratory distress syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Dr. Behcet Uz Children's HospitalUniversity, hospital or other
- Study start
- 30 Mar 2018 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 15 Apr 2020 (actual)
- First posted
- 5 Jun 2020 (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.
Respiratory failure is one of the most common causes of both hospitalization and mortality in patients in the pediatric intensive care unit (PICU). Recently, it is recommended to target driving pressure (ΔP) in patients with ARDS to achieve better results with the administration of optimal mechanical ventilation. In many studies, higher ΔP was associated with mortality in adult ARDS patients; non-ARDS patients' studies showing the relationship between driving pressure and mortality are few, but contradictory results have come out.
This study aimed to determine whether ΔP was associated with mortality in pediatric patients diagnosed as pARDS and non-pARDS who received mechanical ventilation support due to respiratory failure. Patients who received invasive mechanical ventilation support due to respiratory failure in the pediatric intensive care unit over 1 month and under 18 years were included in our study Driving pressure was significantly associated with an increased risk of mortality among mechanically ventilated both pARDS and non-pARDS patients. Future prospective randomized clinical trials are needed to determine a protocol targeting DP can be developed and defining optimum cutoff values.
Detailed description
Respiratory failure is one of the most common causes of both hospitalization and mortality in patients in the pediatric intensive care unit (PICU). Recently, it is recommended to target driving pressure (ΔP) in patients with ARDS to achieve better results with the administration of optimal mechanical ventilation. ΔP is calculated as the difference between Plateau pressure (Pplat) and positive end-expiratory pressure (PEEP) and is determined by the ratio of the tidal volume to the compliance of the respiratory system (ΔP = Pplat - PEEP = VT/CRS). ΔP estimates how much mechanical strain (dynamic strain) the tidal volume causes in the lung. It is a non-invasive and simple method and can be easily calculated at the bedside. In many studies, higher ΔP was associated with mortality in adult ARDS patients; non-ARDS patients' studies showing the relationship between driving pressure and mortality are few, but contradictory results have come out.
This study aimed to determine whether ΔP was associated with mortality in pediatric patients diagnosed as pARDS and non-pARDS who received mechanical ventilation support due to respiratory failure.
Single-center, prospective, observational study of patients admitted to pediatric intensive care units (PICU) in Turkey. In our study, the ethics committee was approved by The Health Sciences University Izmir Behcet Uz Child Health and Diseases education and research hospital ethics committee (protocol no: 2019-344).In our study, patients who received invasive mechanical ventilation support due to respiratory failure in the pediatric intensive care unit over 1 month and under 18 years were included in the study between March 2018 and April 2020. Mechanically ventilated patients (via ETT or trachestomy) were recorded for patients whose ventilation duration lasted at least 24 hours. We divided the patients into two groups by calculating the oxygenation index (OI): [mean airway pressure(MAP) × fraction of inspired oxygen (FiO2) ]/ partial pressure of oxygen in arterial blood (PaO2) × 100) used in the classification of PALICC, including ARDS and non-ARDS. PARDS definition was also identified based on the PALICC criteria. Data were prospectively recorded on day 1 including patient demographics, ventilator settings (VT, VT / ideal body weight (IBW), respiratory rate (RR), peak inspiratory pressure (PIP), plateau pressure (Pplat), mean airway pressure (Pmean), minute volume (VE), end-expiratory pressure (PEEP), static compliance (Cstat), fraction of inspired oxygen FIO2, inspiratory time ( IT), expiratory time (ET) and we calculated oxygenation index (OI), cstat (VT/∆P), partial pressure of oxygen in arterial blood (PaO2) /FiO2, driving pressure (ΔP), the pediatric index of mortality (PRISM) III scores and pediatric sequential organ failure assessment (pSOFA) scores.
All patients were ventilated with volume control (VCV) or pressure control (PCV) mode during the hospitalization. İn order to measure the driving pressure of patients, Pplat was measured in the mechanical ventilator every 12 hours using an inspiratory hold maneuver. The average Pplat was calculated using the mean of 2 measurements within 24 hours. Then, the total PEEP was measured by expiratory hold maneuver and ΔP was calculated with the Pplat-PEEP formula. Patients were followed for 30 days until hospital discharge. We used ΔP compared to other mechanic ventilator parameters between survivors and non-survivors at day 30. Besides, ΔP and other parameters of patients in the ARDS and non-ARDS groups were compared with their 30-day mortality.
Statistical Analyses Primarily, we evaluated the relationship between ΔP and mortality in patients with ARDS and non-ARDS. Our second target was to evaluate the relationship between mortality and ΔP and other mechanical ventilator parameters.
Driving pressure and other lung dynamics; according to the type and distribution of the data was compared with chi-square, Wilcoxon, Independent-T-test or Mann-Whitney-U test and p <0.05 was considered statistically significant. The strength of the association between the two variables was measured using the correlation coefficient. We used Pearson correlation to parametric variable and Spearman correlation to the nonparametric variable to detect covariances before logistic regression analysis. We evaluated with spearman's correlation analysis to detect covariances before logistic regression analysis. Parameters found significant with mortality in univariate analyzes were evaluated by Logistic Regression analysis. (odds ratio [OR] and 95 % confidence intervals [CI]) Model fit was assessed using Hosmer-Lemeshow statistics.
For the multivariable analysis, we identified covariates that may be associated with mortality. VT /IBW, PaO2, OI, FiO2, PRISM III score, Days of ventilation and pSOFA score were not collinear with ΔP. We did not include Pplat, PIP, Pmean in logistic regression models containing ΔP given concerns for collinearity Individual covariates included age, gender, PRISM III score, PaO2, OI, FiO2, Days of ventilation and pSOFA score. We created 3 other modeling analyzes for Pplat, PIP, Pmean, because of collinearity with driving pressure. We evaluated this model to determine the best parameter related to mortality in whole patients under mechanical ventilation support due to respiratory failure. ΔP cut off (13 cmH2O) values in adult studies in the literature were categorized and mortality was estimated by a receiver operating characteristic (ROC). We performed all statistical analyses using IBM SPSS Statistics for Windows version 22 (Armonk, NY) for analysis.
Mechanical ventilation is one of the most common indications for admission to a pediatric intensive care unit (PICU), with up to 64% of admitted children requiring mechanical ventilation. Driving pressure (ΔP), which is calculated as end-inspiratory plateau pressure (Pplat) minus applied positive end-expiratory pressure (PEEP) and is equivalent to the ratio between the VT and compliance of the respiratory system, can reduce mortality with children who received mechanical ventilator support due to respiratory failure. ΔP is a non-invasive and simple method and can be easily calculated at the bedside.
Recent data in the adult ARDS population have shown that the ΔP is most related to mortality. Our study, we have shown that the ΔP on day 1 was associated with hospital mortality in with pARDS patients.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with pARDS | – | Device: driving pressureWithin 7 days of known clinical insult Respiratory failure not fully explained by cardiac failure or fluid overload chest imaging findings of new infiltrate(s) consistent with acute pulmonary parenchymal disease patients with an oxygenation index (OI) ([FIO2 × mean airway pressure × 100]/PaO2) above 4 |
| Patients with non-pARDS | – | Device: driving pressurenon-pARDS patients who received mechanical ventilation support due to respiratory failure. |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- In our study, patients who received invasive mechanical ventilation support due to respiratory failure in the pediatric intensive care unit over 1 month and under 18 years were included in the study between March 2018 and April 2020. Mechanically ventilated patients (via ETT or trachestomy) were recorded for patients whose ventilation duration lasted at least 24 hours. We divided the patients into two groups by calculating the oxygenation index (OI): [mean airway pressure(MAP) × fraction of inspired oxygen (FiO2) ]/ partial pressure of oxygen in arterial blood (PaO2) × 100) used in the classification of PALICC, including ARDS and non-ARDS.
Key inclusion criteria (1 listed)
- In our study, patients who received invasive mechanical ventilation support for at least 24 hours due to respiratory failure in the pediatric intensive care unit over 1 month and under 18 years were included in the study between March 2018 and April 2020.
Key exclusion criteria (1 listed)
- patients who died within the first 24 hours and patients whose desired respiratory mechanics were not measured and data deficiencies were detected
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 |
|---|---|---|
| driving pressureMechanically ventilated patients (via ETT or trachestomy) were recorded for patients whose ventilation duration lasted at least 24 hours.We divided the patients into two groups by calculating the oxygenation index (OI): [mean airway pressure(MAP) × fraction of inspired oxygen (FiO2) ]/ partial pressure of oxygen in arterial blood (PaO2) × 100) used in the classification of PALICC, including pARDS and non-pARDS. | Device | Patients with non-pARDS, Patients with pARDS |
Primary outcome
Driving pressure and mortality with all patients
Time frame: march 2018-april 2020
Driving pressure and other lung dynamics; according to the type and distribution of the data was compared with chi-square, Wilcoxon, Independent-T-test or Mann-Whitney-U test and p <0.05 was considered statistically significant.
1 secondary outcome
Driving pressure with mortality in patients with pARDS and non-pARDS patients
Time frame: march 2018-april 2020
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2020.
- Results publication: PubMed 22926653Ferguson ND, Fan E, Camporota L, Antonelli M, Anzueto A, Beale R, Brochard L, Brower R, Esteban A, Gattinoni L, Rhodes A, Slutsky AS, Vincent JL, Rubenfeld GD, Thompson BT, Ranieri VM. The Berlin definition of ARDS: an expanded rationale, justification, and supplementary material. Intensive Care Med. 2012 Oct;38(10):1573-82. doi: 10.1007/s00134-012-2682-1. Epub 2012 Aug 25.
- Results publication: PubMed 20228688Santschi M, Jouvet P, Leclerc F, Gauvin F, Newth CJ, Carroll CL, Flori H, Tasker RC, Rimensberger PC, Randolph AG; PALIVE Investigators; Pediatric Acute Lung Injury and Sepsis Investigators Network (PALISI); European Society of Pediatric and Neonatal Intensive Care (ESPNIC). Acute lung injury in children: therapeutic practice and feasibility of international clinical trials. Pediatr Crit Care Med. 2010 Nov;11(6):681-9. doi: 10.1097/PCC.0b013e3181d904c0.
- Results publication: PubMed 25647235Pediatric Acute Lung Injury Consensus Conference Group. Pediatric acute respiratory distress syndrome: consensus recommendations from the Pediatric Acute Lung Injury Consensus Conference. Pediatr Crit Care Med. 2015 Jun;16(5):428-39. doi: 10.1097/PCC.0000000000000350.
- Results publication: PubMed 28936698Kneyber MCJ, de Luca D, Calderini E, Jarreau PH, Javouhey E, Lopez-Herce J, Hammer J, Macrae D, Markhorst DG, Medina A, Pons-Odena M, Racca F, Wolf G, Biban P, Brierley J, Rimensberger PC; section Respiratory Failure of the European Society for Paediatric and Neonatal Intensive Care. Recommendations for mechanical ventilation of critically ill children from the Paediatric Mechanical Ventilation Consensus Conference (PEMVECC). Intensive Care Med. 2017 Dec;43(12):1764-1780. doi: 10.1007/s00134-017-4920-z. Epub 2017 Sep 22.
- Results publication: PubMed 10793162Acute Respiratory Distress Syndrome Network; Brower RG, Matthay MA, Morris A, Schoenfeld D, Thompson BT, Wheeler A. Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med. 2000 May 4;342(18):1301-8. doi: 10.1056/NEJM200005043421801.
- Results publication: PubMed 24283226Slutsky AS, Ranieri VM. Ventilator-induced lung injury. N Engl J Med. 2013 Nov 28;369(22):2126-36. doi: 10.1056/NEJMra1208707. No abstract available.
- Results publication: PubMed 30447683Guo L, Xie J, Huang Y, Pan C, Yang Y, Qiu H, Liu L. Higher PEEP improves outcomes in ARDS patients with clinically objective positive oxygenation response to PEEP: a systematic review and meta-analysis. BMC Anesthesiol. 2018 Nov 17;18(1):172. doi: 10.1186/s12871-018-0631-4.
- Results publication: PubMed 19533092Khemani RG, Conti D, Alonzo TA, Bart RD 3rd, Newth CJ. Effect of tidal volume in children with acute hypoxemic respiratory failure. Intensive Care Med. 2009 Aug;35(8):1428-37. doi: 10.1007/s00134-009-1527-z. Epub 2009 Jun 17.
- Results publication: PubMed 20197533Briel M, Meade M, Mercat A, Brower RG, Talmor D, Walter SD, Slutsky AS, Pullenayegum E, Zhou Q, Cook D, Brochard L, Richard JC, Lamontagne F, Bhatnagar N, Stewart TE, Guyatt G. Higher vs lower positive end-expiratory pressure in patients with acute lung injury and acute respiratory distress syndrome: systematic review and meta-analysis. JAMA. 2010 Mar 3;303(9):865-73. doi: 10.1001/jama.2010.218.
- Results publication: PubMed 25693014Amato MB, Meade MO, Slutsky AS, Brochard L, Costa EL, Schoenfeld DA, Stewart TE, Briel M, Talmor D, Mercat A, Richard JC, Carvalho CR, Brower RG. Driving pressure and survival in the acute respiratory distress syndrome. N Engl J Med. 2015 Feb 19;372(8):747-55. doi: 10.1056/NEJMsa1410639.
- Results publication: PubMed 29135500Aoyama H, Pettenuzzo T, Aoyama K, Pinto R, Englesakis M, Fan E. Association of Driving Pressure With Mortality Among Ventilated Patients With Acute Respiratory Distress Syndrome: A Systematic Review and Meta-Analysis. Crit Care Med. 2018 Feb;46(2):300-306. doi: 10.1097/CCM.0000000000002838.
- Results publication: PubMed 31396419Chen Z, Wei X, Liu G, Tai Q, Zheng D, Xie W, Chen L, Wang G, Sun JQ, Wang S, Liu N, Lv H, Zuo L. Higher vs. Lower DP for Ventilated Patients with Acute Respiratory Distress Syndrome: A Systematic Review and Meta-Analysis. Emerg Med Int. 2019 Jul 18;2019:4654705. doi: 10.1155/2019/4654705. eCollection 2019.
- Individual participant dataSharing planned: Undecided. we will share our data in the future
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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.
ekin soydan principal investigator
Investigator
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, Human and Respiratory Failure, run by Dr. Behcet Uz Children's Hospital at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 5 Jun 2020. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Driving pressure and mortality with all patients (time frame: march 2018-april 2020). 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 NCT04419376, which also lists 28 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 5 Jun 2020.