Acute Lung InjuryNCT04541199
Driving Pressures in a Closed-loop and a Conventional Mechanical Ventilation Mode
A study testing closed loop and conventional in people with Acute Lung Injury, run by Dr. Behcet Uz Children's Hospital at 1 site in Turkey (Türkiye).
Trial summary
In mechanically ventilated patients, driving pressure (ΔP) assess the strain applied to the respiratory system and is related to ICU mortality. The aim of this randomized cross-over trial was to compare ΔP selected by a closed-loop system and by physician tailored mechanical ventilation mode. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Acute Lung Injury
- What is being tested?
- closed loop and conventional
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Aug 2019to 31 Mar 2021
- Phase
- Interventional
- 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
Who may be able to join
- All the mechanically ventilated children
- between 1-months and 18-years-old
- without any detectable respiratory effort
- whose clinical condition are not foreseen to change within the next 3 hours
Who cannot join
- septic shock
- brain death diagnose,
- with a leak equal or more than 40% of the current VT,
- receiving extracorporeal membrane oxygenation (ECMO) or targeted temperature management (TTM),
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
Official title: Randomized Crossover Trial to Compare Driving Pressures in a Closed-loop and a Conventional Mechanical Ventilation Mode in Pediatric Patients
In mechanically ventilated patients, driving pressure (ΔP) assess the strain applied to the respiratory system and is related to ICU mortality. The aim of this randomized cross-over trial was to compare ΔP selected by a closed-loop system and by physician tailored mechanical ventilation mode. Pediatric patients admitted to PICU will be enrolled if they were invasively ventilated without any detectable respiratory effort, hemodynamic instability, or significant leakages. Two 60 minute periods of ventilation determined by randomization in APV-CMV and ASV 1.1 will be compared. Settings were adjusted to reach the same minute ventilation in both modes. ΔP will be calculated as the difference between plateau pressure and total PEEP measured using end-inspiratory and end-expiratory occlusion maneuvers, respectively.
Read the detailed description
In 2015, Pediatric Acute Lung Injury Consensus Conference (PALICC) determined the pediatric acute respiratory distress syndrome (PARDS) definition. PALICC recommends using patient-specific tidal volume (VT) according to disease severity. Moreover, in the absence of transpulmonary pressure measurements (PL), an inspiratory plateau pressure limit of 28 cm H2O is recommended, allowing for slightly higher plateau pressures (29-32 cm H2O) for patients with reduced chest wall compliance. In adult ARDS, Amato et al. normalized VT to the compliance(C) by using driving pressure (ΔP) and reported that ΔP was the ventilation variable that best-stratified risk. Changes in ventilator settings resulting in a decrease in ΔP were associated with increased survival. One of the most common modes used in pediatric ventilation nowadays is synchronized controlled mandatory ventilation with adaptive pressure ventilation (APV-CMV). As compared to pressure control mode (P-CMV), APV-CMV prevents low or high VT when the compliance changes by adjusting the applied pressure. Adaptive support ventilation (ASV) is closed-loop ventilation mode, which for a given minute volume set by the clinician, adapts tidal volume (VT) and respiratory rate (RR) according to the patient's respiratory mechanics.
This prospective randomized cross over study aimed to compare ΔP between physician tailored APV-CMV mode and ASV 1.1 in pediatric mechanically ventilated patients with acute respiratory failure. After the enrollment, the patients' ventilation periods will be determined by randomization using sealed opaque envelopes. The minute ventilation, fraction of inspired O2 (FiO2) and positive end-expiratory pressure (PEEP) set by the clinician before study inclusion will be kept unchanged during all study periods. Patients will be ventilated in each mode for 60 minutes. Three consecutive -inspiratory and end-expiratory occlusion will be performed at 30 and 60 min and ΔP will be calculated for each period. Arterial blood gas will be measured at the end of each period. A wash-out period of 30 min using the ventilation mode and setting before inclusion will be performed in between the two study ventilation periods. ΔP will be calculated as the difference between plateau pressure (Pplat) and total PEEP and will be averaged for each ventilation period by using the mean of the six measurements mentioned above. VT will be calculated by integration of flow measurement. Resistance will be calculated by the least-squares fitting method. The expiratory time constant (RCexp) will be derived from the volume-flow curve at 75% of the VT and corresponding flow value. Static compliance (Cstat) will be calculated as VT divided by ΔP.
The primary outcome will be ΔP. The secondary outcome will be VT, RR, Pplat, Ti, Te, Cstat, Resistance, RCexp, pH, PaO2, PaCO2 A pilot study was performed to calculate the sample size. The mean ΔP was 12.4 (±3.31) cm H2O in ASV 1.1 and 13.5 (±4.2) cm H2O in APV-CMV. By using these pilot data, and assuming the power of 0.95 and α-error of 0.05, investigators have calculated the study size as 26 patients.
- Conditions
- Acute Lung Injury
- Being tested
- closed loop, conventional
- Keywords
- Driving pressure,, Pediatric acute respiratory distress syndrome (PARDS),, Acute lung injury (ALI),, Closed loop ventilation, Pediatric intnsive care unit (PICU)
- Medical subject headings
- Acute Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
closed loopDevice
RR and VT will be selected according to the respiratory mechanics by closed loop algorithm
conventionalDevice
RR, VT, Ti will be selected by the clinician according to the respiratory mechanics
| Study group | Role | What they receive |
|---|---|---|
| Conventional | Active comparator | Not described Receives: Device: conventional |
| Closed-loop | Experimental | Not described Receives: Device: closed loop |
What is being measured
The primary outcome is the main question the study is designed to answer.
Driving pressure
measured with an occlusion maneuver as the difference between plateau pressure (Pplat) and total PEEP
Measured: at the end of period (60th minute)
Secondary outcomes (9)
Tidal Volume (VT)
Integrated from flow measurement
Measured: continuous measurement over 1 hour
Respiratory rate (RR)
Number of mechanically triggered breaths by the ventilator in 60 seconds
Measured: continuous measurement over 1 hour
Expiratory time constant (RCexp)
Measured: continious measurement over 1 hour
Static compliance (Cstat)
will be derived from volume-flow curve at 75% of the VT and corresponding flow value
Measured: continuous measurement over 1 hour
Inspiratory time (Ti)
Time used for inspiration during each mechanically triggered breath
Measured: continuous measurement over 1 hour
Expiratory time (Te)
Time used for expiration during each mechanically triggered breath
Measured: continuous measurement over 1 hour
pH
the measure of the hydrogen ion (H-) concentration in arterial blood
Measured: one measurement after 1 hour
PaO2
measurement of oxygen pressure in arterial blood
Measured: one measurement after 1 hour
PaCO2
measurement of CO2 pressure in arterial blood
Measured: one measurement after 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2020
- Study start30 Aug 2019
- Primary completion31 Mar 2021
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Acute Lung InjuryStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Behcet Uz Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hasan ağın, Dr. Behcet Uz Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04541199
- Sponsor's protocol ID
- 02018/205
- Status last verified
- Aug 2021
- First submitted
- 24 Aug 2020
- Last updated
- 31 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: this will be decided depending on the approval of the patients in the written informed consent
Publications
Santschi 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 28936698Amato 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 25693014Imber DA, Thomas NJ, Yehya N. Association Between Tidal Volumes Adjusted for Ideal Body Weight and Outcomes in Pediatric Acute Respiratory Distress Syndrome. Pediatr Crit Care Med. 2019 Mar;20(3):e145-e153. doi: 10.1097/PCC.0000000000001846.
PubMed 30640889Ceylan G, Topal S, Atakul G, Colak M, Soydan E, Sandal O, Sari F, Agin H. Randomized crossover trial to compare driving pressures in a closed-loop and a conventional mechanical ventilation mode in pediatric patients. Pediatr Pulmonol. 2021 Sep;56(9):3035-3043. doi: 10.1002/ppul.25561. Epub 2021 Jul 22.
PubMed 34293255
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Crossover Trial to Compare Driving Pressures in a Closed-loop and a Conventional Mechanical Ventilation Mode in Pediatric Patients
- ClinicalTrials.gov ID
- NCT04541199
- Acronym / sponsor ID
- 02018/205
- Conditions
- Acute Lung Injury
- Keywords
- Driving pressure,, Pediatric acute respiratory distress syndrome (PARDS),, Acute lung injury (ALI),, Closed loop ventilation, Pediatric intnsive care unit (PICU)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Dr. Behcet Uz Children's HospitalUniversity, hospital or other
- Study start
- 30 Aug 2019 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 9 Sep 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.
In mechanically ventilated patients, driving pressure (ΔP) assess the strain applied to the respiratory system and is related to ICU mortality. The aim of this randomized cross-over trial was to compare ΔP selected by a closed-loop system and by physician tailored mechanical ventilation mode. Pediatric patients admitted to PICU will be enrolled if they were invasively ventilated without any detectable respiratory effort, hemodynamic instability, or significant leakages. Two 60 minute periods of ventilation determined by randomization in APV-CMV and ASV 1.1 will be compared. Settings were adjusted to reach the same minute ventilation in both modes. ΔP will be calculated as the difference between plateau pressure and total PEEP measured using end-inspiratory and end-expiratory occlusion maneuvers, respectively.
Detailed description
In 2015, Pediatric Acute Lung Injury Consensus Conference (PALICC) determined the pediatric acute respiratory distress syndrome (PARDS) definition. PALICC recommends using patient-specific tidal volume (VT) according to disease severity. Moreover, in the absence of transpulmonary pressure measurements (PL), an inspiratory plateau pressure limit of 28 cm H2O is recommended, allowing for slightly higher plateau pressures (29-32 cm H2O) for patients with reduced chest wall compliance. In adult ARDS, Amato et al. normalized VT to the compliance(C) by using driving pressure (ΔP) and reported that ΔP was the ventilation variable that best-stratified risk. Changes in ventilator settings resulting in a decrease in ΔP were associated with increased survival. One of the most common modes used in pediatric ventilation nowadays is synchronized controlled mandatory ventilation with adaptive pressure ventilation (APV-CMV). As compared to pressure control mode (P-CMV), APV-CMV prevents low or high VT when the compliance changes by adjusting the applied pressure. Adaptive support ventilation (ASV) is closed-loop ventilation mode, which for a given minute volume set by the clinician, adapts tidal volume (VT) and respiratory rate (RR) according to the patient's respiratory mechanics.
This prospective randomized cross over study aimed to compare ΔP between physician tailored APV-CMV mode and ASV 1.1 in pediatric mechanically ventilated patients with acute respiratory failure. After the enrollment, the patients' ventilation periods will be determined by randomization using sealed opaque envelopes. The minute ventilation, fraction of inspired O2 (FiO2) and positive end-expiratory pressure (PEEP) set by the clinician before study inclusion will be kept unchanged during all study periods. Patients will be ventilated in each mode for 60 minutes. Three consecutive -inspiratory and end-expiratory occlusion will be performed at 30 and 60 min and ΔP will be calculated for each period. Arterial blood gas will be measured at the end of each period. A wash-out period of 30 min using the ventilation mode and setting before inclusion will be performed in between the two study ventilation periods. ΔP will be calculated as the difference between plateau pressure (Pplat) and total PEEP and will be averaged for each ventilation period by using the mean of the six measurements mentioned above. VT will be calculated by integration of flow measurement. Resistance will be calculated by the least-squares fitting method. The expiratory time constant (RCexp) will be derived from the volume-flow curve at 75% of the VT and corresponding flow value. Static compliance (Cstat) will be calculated as VT divided by ΔP.
The primary outcome will be ΔP. The secondary outcome will be VT, RR, Pplat, Ti, Te, Cstat, Resistance, RCexp, pH, PaO2, PaCO2 A pilot study was performed to calculate the sample size. The mean ΔP was 12.4 (±3.31) cm H2O in ASV 1.1 and 13.5 (±4.2) cm H2O in APV-CMV. By using these pilot data, and assuming the power of 0.95 and α-error of 0.05, investigators have calculated the study size as 26 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional | Active comparator | Device: conventional |
| Closed-loop | Experimental | Device: closed loop |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- All the mechanically ventilated children
- between 1-months and 18-years-old
- without any detectable respiratory effort
- whose clinical condition are not foreseen to change within the next 3 hours
Key exclusion criteria (4 listed)
- septic shock
- brain death diagnose,
- with a leak equal or more than 40% of the current VT,
- receiving extracorporeal membrane oxygenation (ECMO) or targeted temperature management (TTM),
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 |
|---|---|---|
| closed loopRR and VT will be selected according to the respiratory mechanics by closed loop algorithm | Device | Closed-loop |
| conventionalRR, VT, Ti will be selected by the clinician according to the respiratory mechanics | Device | Conventional |
Primary outcome
Driving pressure
Time frame: at the end of period (60th minute)
measured with an occlusion maneuver as the difference between plateau pressure (Pplat) and total PEEP
9 secondary outcomes
Tidal Volume (VT)
Time frame: continuous measurement over 1 hour
Respiratory rate (RR)
Time frame: continuous measurement over 1 hour
Expiratory time constant (RCexp)
Time frame: continious measurement over 1 hour
Static compliance (Cstat)
Time frame: continuous measurement over 1 hour
Inspiratory time (Ti)
Time frame: continuous measurement over 1 hour
Expiratory time (Te)
Time frame: continuous measurement over 1 hour
pH
Time frame: one measurement after 1 hour
PaO2
Time frame: one measurement after 1 hour
PaCO2
Time frame: one measurement after 1 hour
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 31 Aug 2021.
- Background: 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.
- Background: 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.
- Background: 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.
- Background: 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.
- Background: PubMed 30640889Imber DA, Thomas NJ, Yehya N. Association Between Tidal Volumes Adjusted for Ideal Body Weight and Outcomes in Pediatric Acute Respiratory Distress Syndrome. Pediatr Crit Care Med. 2019 Mar;20(3):e145-e153. doi: 10.1097/PCC.0000000000001846.
- Derived from this study: PubMed 34293255Ceylan G, Topal S, Atakul G, Colak M, Soydan E, Sandal O, Sari F, Agin H. Randomized crossover trial to compare driving pressures in a closed-loop and a conventional mechanical ventilation mode in pediatric patients. Pediatr Pulmonol. 2021 Sep;56(9):3035-3043. doi: 10.1002/ppul.25561. Epub 2021 Jul 22.
- Individual participant dataSharing planned: Undecided. this will be decided depending on the approval of the patients in the written informed consent
Related trials for Acute Lung Injury
RecruitingPhase 3
Fibrotic Disease Activity in Cardiopulmonary Disorders Using 18F-Fibroblast Activation Protein Inhibitor (18F-FAPI-74) PET/CT Imaging
Allogeneic Stem Cell Transplantation, Lung Allograft Transplantation
RecruitingObservational study
Pulmonary Immune Cell-microbiome Interactions in ARDS
ARDS, Human
Recruiting
Percutaneous Electrical Nerve Field Stimulation (PENFS) in Patients With Post Concussion Syndrome (PCS)
Post-Concussion Syndrome, COVID Long-Haul
RecruitingPhase 2
Rhu-pGSN for Acute Respiratory Distress Syndrome (ARDS)
Acute Respiratory Distress Syndrome, Infections
RecruitingObservational study
CytOSorb TreatMent Of Critically Ill PatientS Registry
Septic Shock, Acute Respiratory Distress Syndrome
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing closed loop and conventional in people with Acute Lung Injury, 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 4 inclusion and 4 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 31 Aug 2021. 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 (time frame: at the end of period (60th minute)). 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 NCT04541199, which also lists 6 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 31 Aug 2021.