ARDS: Acute Respiratory Distress SyndromeNCT06755320
Compare Between APRV and Bipap Ventilation in ARDS Patients
A study testing mechanical ventilation (MV) in people with ARDS: Acute Respiratory Distress Syndrome and ARDS, run by Ain Shams University.
Trial summary
To evaluate whether early use of airway pressure release ventilation would improve oxgyenation , improve lung compliance and shorten the time of mechanical ventilation compared to BIPAP ventilation in ARDS patients Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- ARDS: Acute Respiratory Distress Syndrome, ARDS
- What is being tested?
- mechanical ventilation (MV)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Dec 2024to Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who meet all ARDS criteria (according to Berlin definition).
- Patients who had received endotracheal intubation and mechanical ventilation for <48h prior to inclusion.
Who cannot join
- Age below 18 years and above 65 years.
- Presence of significant chronic pulmonary disorder (chronic obstructive pulmonary disease, idiopathic pulmonary fibrosis, suppurative lung disease or diffuse alveolar hemorrhage) or documented barotrauma.
- Presence of cardiac disorder (rheumatic or ischemic heart disease).
- Presence of intracranial hypertension (suspected or confirmed).
- History of malignancies or patients on immunosuppressive drugs.
- Pregnancy or presence of neuromuscular disorder known to prolong intubation.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparative Study Between Airway Pressure Release Ventilation and Bi-level Positive Airway Pressure Ventilation in Acute Respiratory Distress Syndrome
To evaluate whether early use of airway pressure release ventilation would improve oxgyenation , improve lung compliance and shorten the time of mechanical ventilation compared to BIPAP ventilation in ARDS patients
Read the detailed description
Acute respiratory distress syndrome (ARDS) is an extremely dangerous lung condition that leads to low blood oxygen levels, and is commonly caused by sepsis, pneumonia, aspiration, and trauma. Despite great improvements in mechanical ventilation in recent years, the mortality rate of ARDS is still high. Low tidal volume ventilation (LTVV), optimum positive end-expiratory pressure, permissive hypercapnia, lung recruitment, and the prone position are common treatments for ARDS .
Lung recruitment maneuvers (LRMs) are a common element of the "open lung" approach to lung-protective ventilation. Given that atelectasis increases alveolar stress and strain during tidal ventilation, LRMs may mitigate ventilator-induced lung injury (VILI) and reduce the considerable risk of death for patients with ARDS. However, the transient application of high airway pressures may impair cardiovascular function and traumatize the pulmonary epithelium (barotrauma). Consequently, the use of LRMs is controversial .
APRV and BIPAP are modes of mechanical ventilation that allow unrestricted spontaneous breathing independent of ventilator cycling, using an active expiratory valve. Both modes are pressure-limited. Ventilation occurs via the time-cycled switching between two set pressure levels .
Bilevel positive airway pressure is a partial support mode that employs pressure-controlled, time-cycled ventilation set at two levels of continuous positive airway pressure (CPAP) with unrestricted spontaneous breathing. Which can occur at any phase of the mechanical ventilatory cycle. Bilevel positive airway pressure is able to modulate the inspiratory effort by modifying the frequency of controlled breaths .
In traditional biphasic ventilation, the inspiratory to expiratory ratio is not inverse. This ratio often distinguishes biphasic ventilation from APRV. Ventilator parameters set in this mode include the inspiratory pressure limit (Phigh), inspiratory time (Thigh), PEEP level (Plow), rate, and fraction of inspired oxgyen (FiO2). On some ventilators, pressure support may be added to augment the patient's spontaneous breaths .
Airway pressure release ventilation (APRV) is defined as a continuous positive airway pressure (CPAP) with a brief intermittent release phase based on the open lung concept; it also perfectly fits the ARDS treatment principle. Despite this, APRV has not been widely used in the past, rather only as a rescue measure for ARDS patients who are difficult to oxygenate .
APRV is a form of pressure controlled intermittent mandatory ventilation that is designed to allow unrestricted spontaneous breathing through the breath cycle, especially during Timehigh (Thigh).it is also applied using I:E ratios much greater than 1:1 or inverse ratio ventilation, usually relying on short expiratory times and gas trapping to maintain end-expiratory lung volume. APRV improve oxygenation and decrease the amount of alveolar derecruitment during the Timelow (Tlow) .
All preexisting data did not address the question for which APRV was being promoted, is that APRV should be used as initial mode of mechanical ventilation for patients with ARDS. Multiple reports and studies in animals and humans have not helped answer this question. Not only is there paucity in the number of high quality trials in humans, but there is a lack of consistency on how APRV is applied .
Over recent years, with an increased understanding of the pathophysiology of ARDS, APRV has been re-proposed to improve patient prognosis. Nevertheless, this mode is still not routinely used in ARDS patients .
Compared to the classical ventilation, APRV has been shown to provide lower peak pressure, better oxygenation, less circulatory loss, and better gas exchange without deteriorating the hemodynamic condition of the ARDS patient .
- Conditions
- ARDS: Acute Respiratory Distress Syndrome, ARDS
- Being tested
- mechanical ventilation (MV)
- Keywords
- ARDS, APRV, BiPAP
- 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.
mechanical ventilation (MV)Other
Mechanical ventilation APRV mode ( Airway Pressure Release Ventilation )
mechanical ventilation (MV)Other
Mechanical Ventilation in BiPAP mode (Bi-Level Positive Airway Pressure Ventilation )
| Study group | Role | What they receive |
|---|---|---|
| APRV | Other | The settings for APRV were:
* High airway pressure (Phigh) set at the last plateau airway pressure (Pplat), not to exceed 30 cmH2O and low airway pressure (Plow) set at (5 cmH2O).
* The release phase (Tlow) setting adjusted to terminate the peak expiratory flow rate to ≥ 50%.
* Release frequency of 10-14 cycles/min. Receives: Other: mechanical ventilation (MV) |
| BiPAP | Other | The settings for BiPAP were:
* Ti (inspiratory time) is set according to inspiratory time constant.
* Optimum PEEP is set according to FiO2 to achieve the goal of SpO2≥90%.
* FiO2 is set to achieve the goal of SpO2≥ 90%. Receives: Other: mechanical ventilation (MV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
partial pressure of oxgyen in arterial blood
To evaluate whether early use of airway pressure release ventilation (APRV) would improve oxygenation (as assessed by partial pressure of oxygen in the arterial blood (PaO2)).
Measured: an average of 6 months
Secondary outcomes (1)
Number of days on mechanical ventilation
recording number of days patients were on mechanical ventilation in intensive care unit (ICU )
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2025
- Study startDec 2024 (estimated)
- Primary completionJun 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for ARDS: Acute Respiratory Distress SyndromeStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective Randomized Clinical Trial.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rana Ayman, Ain Shams University
- Investigators
- Rana A Mohamed, MSc, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06755320
- Sponsor's protocol ID
- APRV versus Bipap
- Status last verified
- Dec 2024
- First submitted
- 22 Nov 2024
- Last updated
- 1 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To ensure ultimate patients' privacy and disclosure , IPD might not be shared , but data will be available with the corresponding author on special request .
Publications
Fredericks AS, Bunker MP, Gliga LA, Ebeling CG, Ringqvist JR, Heravi H, Manley J, Valladares J, Romito BT. Airway Pressure Release Ventilation: A Review of the Evidence, Theoretical Benefits, and Alternative Titration Strategies. Clin Med Insights Circ Respir Pulm Med. 2020 Feb 5;14:1179548420903297. doi: 10.1177/1179548420903297. eCollection 2020.
PubMed 32076372Saddy F, Moraes L, Santos CL, Oliveira GP, Cruz FF, Morales MM, Capelozzi VL, de Abreu MG, Garcia CS, Pelosi P, Rocco PR. Biphasic positive airway pressure minimizes biological impact on lung tissue in mild acute lung injury independent of etiology. Crit Care. 2013 Oct 8;17(5):R228. doi: 10.1186/cc13051.
PubMed 24103805Goligher EC, Hodgson CL, Adhikari NKJ, Meade MO, Wunsch H, Uleryk E, Gajic O, Amato MPB, Ferguson ND, Rubenfeld GD, Fan E. Lung Recruitment Maneuvers for Adult Patients with Acute Respiratory Distress Syndrome. A Systematic Review and Meta-Analysis. Ann Am Thorac Soc. 2017 Oct;14(Supplement_4):S304-S311. doi: 10.1513/AnnalsATS.201704-340OT.
PubMed 29043837Gallagher JJ. Alternative Modes of Mechanical Ventilation. AACN Adv Crit Care. 2018 Winter;29(4):396-404. doi: 10.4037/aacnacc2018372.
PubMed 30523010Mireles-Cabodevila E, Dugar S, Chatburn RL. APRV for ARDS: the complexities of a mode and how it affects even the best trials. J Thorac Dis. 2018 Apr;10(Suppl 9):S1058-S1063. doi: 10.21037/jtd.2018.03.156. No abstract available.
PubMed 29850185Cheng J, Ma A, Dong M, Zhou Y, Wang B, Xue Y, Wang P, Yang J, Kang Y. Does airway pressure release ventilation offer new hope for treating acute respiratory distress syndrome? J Intensive Med. 2022 Mar 28;2(4):241-248. doi: 10.1016/j.jointm.2022.02.003. eCollection 2022 Oct.
PubMed 36785647Zhong X, Wu Q, Yang H, Dong W, Wang B, Zhang Z, Liang G. Airway pressure release ventilation versus low tidal volume ventilation for patients with acute respiratory distress syndrome/acute lung injury: a meta-analysis of randomized clinical trials. Ann Transl Med. 2020 Dec;8(24):1641. doi: 10.21037/atm-20-6917.
PubMed 33490153Kucuk MP, Ozturk CE, Ilkaya NK, Kucuk AO, Ergul DF, Ulger F. The effect of preemptive airway pressure release ventilation on patients with high risk for acute respiratory distress syndrome: a randomized controlled trial. Braz J Anesthesiol. 2022 Jan-Feb;72(1):29-36. doi: 10.1016/j.bjane.2021.03.022. Epub 2021 Apr 24.
PubMed 33905798Rose L, Hawkins M. Airway pressure release ventilation and biphasic positive airway pressure: a systematic review of definitional criteria. Intensive Care Med. 2008 Oct;34(10):1766-73. doi: 10.1007/s00134-008-1216-3. Epub 2008 Jul 17.
PubMed 18633595
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Airway Pressure Release Ventilation and Bi-level Positive Airway Pressure Ventilation in Acute Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT06755320
- Acronym / sponsor ID
- APRV versus Bipap
- Conditions
- ARDS: Acute Respiratory Distress Syndrome, ARDS
- Keywords
- ARDS, APRV, BiPAP
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Dec 2024 (estimated)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 1 Jan 2025 (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.
To evaluate whether early use of airway pressure release ventilation would improve oxgyenation , improve lung compliance and shorten the time of mechanical ventilation compared to BIPAP ventilation in ARDS patients
Detailed description
Acute respiratory distress syndrome (ARDS) is an extremely dangerous lung condition that leads to low blood oxygen levels, and is commonly caused by sepsis, pneumonia, aspiration, and trauma. Despite great improvements in mechanical ventilation in recent years, the mortality rate of ARDS is still high. Low tidal volume ventilation (LTVV), optimum positive end-expiratory pressure, permissive hypercapnia, lung recruitment, and the prone position are common treatments for ARDS .
Lung recruitment maneuvers (LRMs) are a common element of the "open lung" approach to lung-protective ventilation. Given that atelectasis increases alveolar stress and strain during tidal ventilation, LRMs may mitigate ventilator-induced lung injury (VILI) and reduce the considerable risk of death for patients with ARDS. However, the transient application of high airway pressures may impair cardiovascular function and traumatize the pulmonary epithelium (barotrauma). Consequently, the use of LRMs is controversial .
APRV and BIPAP are modes of mechanical ventilation that allow unrestricted spontaneous breathing independent of ventilator cycling, using an active expiratory valve. Both modes are pressure-limited. Ventilation occurs via the time-cycled switching between two set pressure levels .
Bilevel positive airway pressure is a partial support mode that employs pressure-controlled, time-cycled ventilation set at two levels of continuous positive airway pressure (CPAP) with unrestricted spontaneous breathing. Which can occur at any phase of the mechanical ventilatory cycle. Bilevel positive airway pressure is able to modulate the inspiratory effort by modifying the frequency of controlled breaths .
In traditional biphasic ventilation, the inspiratory to expiratory ratio is not inverse. This ratio often distinguishes biphasic ventilation from APRV. Ventilator parameters set in this mode include the inspiratory pressure limit (Phigh), inspiratory time (Thigh), PEEP level (Plow), rate, and fraction of inspired oxgyen (FiO2). On some ventilators, pressure support may be added to augment the patient's spontaneous breaths .
Airway pressure release ventilation (APRV) is defined as a continuous positive airway pressure (CPAP) with a brief intermittent release phase based on the open lung concept; it also perfectly fits the ARDS treatment principle. Despite this, APRV has not been widely used in the past, rather only as a rescue measure for ARDS patients who are difficult to oxygenate .
APRV is a form of pressure controlled intermittent mandatory ventilation that is designed to allow unrestricted spontaneous breathing through the breath cycle, especially during Timehigh (Thigh).it is also applied using I:E ratios much greater than 1:1 or inverse ratio ventilation, usually relying on short expiratory times and gas trapping to maintain end-expiratory lung volume. APRV improve oxygenation and decrease the amount of alveolar derecruitment during the Timelow (Tlow) .
All preexisting data did not address the question for which APRV was being promoted, is that APRV should be used as initial mode of mechanical ventilation for patients with ARDS. Multiple reports and studies in animals and humans have not helped answer this question. Not only is there paucity in the number of high quality trials in humans, but there is a lack of consistency on how APRV is applied .
Over recent years, with an increased understanding of the pathophysiology of ARDS, APRV has been re-proposed to improve patient prognosis. Nevertheless, this mode is still not routinely used in ARDS patients .
Compared to the classical ventilation, APRV has been shown to provide lower peak pressure, better oxygenation, less circulatory loss, and better gas exchange without deteriorating the hemodynamic condition of the ARDS patient .
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective Randomized Clinical Trial.
| Arm | Type | Receives |
|---|---|---|
| APRV | Other | Other: mechanical ventilation (MV)The settings for APRV were: * High airway pressure (Phigh) set at the last plateau airway pressure (Pplat), not to exceed 30 cmH2O and low airway pressure (Plow) set at (5 cmH2O). * The release phase (Tlow) setting adjusted to terminate the peak expiratory flow rate to ≥ 50%. * Release frequency of 10-14 cycles/min. |
| BiPAP | Other | Other: mechanical ventilation (MV)The settings for BiPAP were: * Ti (inspiratory time) is set according to inspiratory time constant. * Optimum PEEP is set according to FiO2 to achieve the goal of SpO2≥90%. * FiO2 is set to achieve the goal of SpO2≥ 90%. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who meet all ARDS criteria (according to Berlin definition).
- Patients who had received endotracheal intubation and mechanical ventilation for <48h prior to inclusion.
Key exclusion criteria (6 listed)
- Age below 18 years and above 65 years.
- Presence of significant chronic pulmonary disorder (chronic obstructive pulmonary disease, idiopathic pulmonary fibrosis, suppurative lung disease or diffuse alveolar hemorrhage) or documented barotrauma.
- Presence of cardiac disorder (rheumatic or ischemic heart disease).
- Presence of intracranial hypertension (suspected or confirmed).
- History of malignancies or patients on immunosuppressive drugs.
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 |
|---|---|---|
| mechanical ventilation (MV)Mechanical ventilation APRV mode ( Airway Pressure Release Ventilation ) | Other | APRV |
| mechanical ventilation (MV)Mechanical Ventilation in BiPAP mode (Bi-Level Positive Airway Pressure Ventilation ) | Other | BiPAP |
Primary outcome
partial pressure of oxgyen in arterial blood
Time frame: an average of 6 months
To evaluate whether early use of airway pressure release ventilation (APRV) would improve oxygenation (as assessed by partial pressure of oxygen in the arterial blood (PaO2)).
1 secondary outcome
Number of days on mechanical ventilation
Time frame: Up to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2025.
- Background: PubMed 32076372Fredericks AS, Bunker MP, Gliga LA, Ebeling CG, Ringqvist JR, Heravi H, Manley J, Valladares J, Romito BT. Airway Pressure Release Ventilation: A Review of the Evidence, Theoretical Benefits, and Alternative Titration Strategies. Clin Med Insights Circ Respir Pulm Med. 2020 Feb 5;14:1179548420903297. doi: 10.1177/1179548420903297. eCollection 2020.
- Background: PubMed 24103805Saddy F, Moraes L, Santos CL, Oliveira GP, Cruz FF, Morales MM, Capelozzi VL, de Abreu MG, Garcia CS, Pelosi P, Rocco PR. Biphasic positive airway pressure minimizes biological impact on lung tissue in mild acute lung injury independent of etiology. Crit Care. 2013 Oct 8;17(5):R228. doi: 10.1186/cc13051.
- Background: PubMed 29043837Goligher EC, Hodgson CL, Adhikari NKJ, Meade MO, Wunsch H, Uleryk E, Gajic O, Amato MPB, Ferguson ND, Rubenfeld GD, Fan E. Lung Recruitment Maneuvers for Adult Patients with Acute Respiratory Distress Syndrome. A Systematic Review and Meta-Analysis. Ann Am Thorac Soc. 2017 Oct;14(Supplement_4):S304-S311. doi: 10.1513/AnnalsATS.201704-340OT.
- Background: PubMed 30523010Gallagher JJ. Alternative Modes of Mechanical Ventilation. AACN Adv Crit Care. 2018 Winter;29(4):396-404. doi: 10.4037/aacnacc2018372.
- Background: PubMed 29850185Mireles-Cabodevila E, Dugar S, Chatburn RL. APRV for ARDS: the complexities of a mode and how it affects even the best trials. J Thorac Dis. 2018 Apr;10(Suppl 9):S1058-S1063. doi: 10.21037/jtd.2018.03.156. No abstract available.
- Background: PubMed 36785647Cheng J, Ma A, Dong M, Zhou Y, Wang B, Xue Y, Wang P, Yang J, Kang Y. Does airway pressure release ventilation offer new hope for treating acute respiratory distress syndrome? J Intensive Med. 2022 Mar 28;2(4):241-248. doi: 10.1016/j.jointm.2022.02.003. eCollection 2022 Oct.
- Background: PubMed 33490153Zhong X, Wu Q, Yang H, Dong W, Wang B, Zhang Z, Liang G. Airway pressure release ventilation versus low tidal volume ventilation for patients with acute respiratory distress syndrome/acute lung injury: a meta-analysis of randomized clinical trials. Ann Transl Med. 2020 Dec;8(24):1641. doi: 10.21037/atm-20-6917.
- Background: PubMed 33905798Kucuk MP, Ozturk CE, Ilkaya NK, Kucuk AO, Ergul DF, Ulger F. The effect of preemptive airway pressure release ventilation on patients with high risk for acute respiratory distress syndrome: a randomized controlled trial. Braz J Anesthesiol. 2022 Jan-Feb;72(1):29-36. doi: 10.1016/j.bjane.2021.03.022. Epub 2021 Apr 24.
- Background: PubMed 18633595Rose L, Hawkins M. Airway pressure release ventilation and biphasic positive airway pressure: a systematic review of definitional criteria. Intensive Care Med. 2008 Oct;34(10):1766-73. doi: 10.1007/s00134-008-1216-3. Epub 2008 Jul 17.
- Individual participant dataSharing planned: No. To ensure ultimate patients' privacy and disclosure , IPD might not be shared , but data will be available with the corresponding author on special request .
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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.
Rana A Mohamed, MSc principal investigator
Ain Shams University
Questions about this trial
What is this clinical trial studying?
A study testing mechanical ventilation (MV) in people with ARDS: Acute Respiratory Distress Syndrome and ARDS, run by Ain Shams University.
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 6 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: opening soon, as of the sponsor's last update on 1 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rana A Mohamed, MSc (+20 1020511666, d.rana386@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
partial pressure of oxgyen in arterial blood (time frame: an average of 6 months). 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 NCT06755320, which also lists 9 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 1 Jan 2025.