ICU Patients Under Invasive Mechanical VentilationPOXTRANCT06421012
Preoxygenation for Tracheal Aspirations in Intensive Care
A study testing Experimental : Patients without additional preoxygenation and Active Comparator : Patients with additional preoxygenation in people with ICU Patients Under Invasive Mechanical Ventilation, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Clearing the airways is a complex phenomenon involving the production of secretions, the nature of mucus (viscosity, elasticity, stringiness, and adhesiveness), ciliary movement, and coughing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ICU Patients Under Invasive Mechanical Ventilation
- What is being tested?
- Experimental : Patients without additional preoxygenation and Active Comparator : Patients with additional preoxygenation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,260 participants
- Where
- 1 siteFrance
- Study dates
- 7 Jan 2025to 10 Dec 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Hospitalized in ICU, under invasive mechanical ventilation for less than 24 hours
- Information and signature of consent by patient or relative/trusted person, or emergency inclusion procedure
Who cannot join
- Patient on ECMO
- Not affiliated to a social security system
- Pregnant
- Under legal protection (curatorship, guardianship or safeguard of justice)
- Patient under AME
- Patient included in another interventional study that may have an impact on the evaluation criteria of the present study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Pitié Salpêtrière
Paris, 75013
Claire FAZILLEAU, 01 42 16 22 75, claire.fazilleau@aphp.fr
Jean Michel CONSTANTIN, Pr, 01 42 17 73 05, jean-michel.constantin@aphp.fr
About this study
Official title: Preoxygenation for Tracheal Aspirations in Intensive Care, a Randomized Controlled Trial
Clearing the airways is a complex phenomenon involving the production of secretions, the nature of mucus (viscosity, elasticity, stringiness, and adhesiveness), ciliary movement, and coughing. In intubated and ventilated patients, endotracheal suctioning occur when the patient is "unable to clear the airways of obstructions hindering the free passage of air." These suctioning can lead to transient desaturation exacerbated by a decrease in cardiac output due to increased mean arterial pressure, promoting cardiac arrhythmias. To minimize these effects, it is recommended to perform additional preoxygenation, by increasing the fraction of O2 in the air delivered to the patient by the ventilator 2-3 minutes before the procedure. These longstanding recommendations were reiterated in 2022, based on outdated studies involving systematic suctioning that required disconnecting the patient from the ventilator.
Currently, suctioning are performed on-demand, based on the patient's congestion status, either through the endotracheal tube cap or a "closed system." Desaturations have become infrequent without establishing that additional preoxygenation can prevent them. Moreover, additional preoxygenation is not without risks. By inducing de-nitrogenation atelectasis with a loss of lung volume, it can exacerbate pre-existing lung injuries in the most severe patients. In less severe cases, preoxygenation leads to transient hyperoxia, with various deleterious effects impacting patient prognosis. Thus, a short-term risk, such as deep desaturations, must be balanced against a medium-term risk of hyperoxia and de-nitrogenation.
Read the detailed description
Clearing the airways is a complex phenomenon involving the production of secretions, the nature of mucus (viscosity, elasticity, stringiness, and adhesiveness), ciliary movement, and coughing. Endotracheal suctioning are performed when the patient is "unable to clear the airways of obstructions hindering the free passage of air." Classically, endotracheal suctioning cause transient desaturation exacerbated by a decrease in cardiac output due to an increase in mean arterial pressure, promoting cardiac arrhythmias. To minimize these effects, it is recommended to perform additional preoxygenation, i.e., increasing the fraction of O2 in the air delivered to the patient by the ventilator 2-3 minutes before the procedure. These longstanding recommendations were reiterated in 2022, based on outdated studies involving systematic suctioning and/or disconnecting the patient from the ventilator.
Today, suctioning are performed on-demand, based on the patient's congestion status, either through the endotracheal tube cap or a "closed system." Desaturations have become rare without establishing that additional preoxygenation can prevent them. Moreover, additional preoxygenation is not without risks. In the short term, it induces de-nitrogenation atelectasis resulting in a loss of lung volume that can worsen pre-existing lung injuries in the most severe patients. In less severe cases, preoxygenation is responsible for transient hyperoxia, with various deleterious effects impacting patient prognosis. Thus, a short-term risk, such as deep desaturations, is juxtaposed with a medium-term risk of hyperoxia and de-nitrogenation.
The investigators hypothesize that the absence of additional preoxygenation is not inferior, in terms of deep desaturations, to the strategy with additional preoxygenation, and it would avoid exposing patients to the risks of de-nitrogenation-induced atelectasis and hyperoxia.
The investigators retained a margin of non-inferiority for the relative risk of 1.1, i.e. an increase of 10% of deep desaturations.
The main analysis will be performed on the per-protocol population (more conservative in non-inferiority trials).The per-protocol population will include patients who had at least one suctioning and for whom the additional preoxygenation strategy allocated by randomisation was followed in at least 70% of all suctioning reported in the patient's care record. Patients who stopped their participation in the study before endpoint timeframe and those who had never had an suctioning will not be included in the per protocol population.
The unit of analysis will be the patient, and a rate of suctioning leading to deep desaturation will be calculated for each patient, as described in the primary endpoint. The mean rate of suctioning leading to deep desaturation will then be calculated by treatment group (with additional preoxygenation / without additional preoxygenation).
- Being tested
- Experimental : Patients without additional preoxygenation, Active Comparator : Patients with additional preoxygenation
- Keywords
- Endotracheal suctioning, Preoxygenation, Ventilation, ICU
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental : Patients without additional preoxygenationProcedure or surgery
Throughout the entire period of their mechanical ventilation, patients will not receive additional preoxygenation before any endotracheal suctioning; their FiO2 value will be maintained constant
Active Comparator : Patients with additional preoxygenationProcedure or surgery
Throughout the entire period of their mechanical ventilation, patients will receive additional preoxygenation at 100% FiO2 for a systematic 2-minute duration prior to any endotracheal suction. Subsequently, the FiO2 will be reset to the previous default value.
| Study group | Role | What they receive |
|---|---|---|
| Patients without additional preoxygenation | Experimental | Not described Receives: Procedure: Experimental : Patients without additional preoxygenation |
| Patients with additional preoxygenation | Active comparator | Not described Receives: Procedure: Active Comparator : Patients with additional preoxygenation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of suctioning leading to deep desaturation
It will be calculated for each patient as the number of suctioning leading to deep desaturation (SpO2 88% or less, and 85% or less for patients with chronic obstructive pulmonary disease COPD), divided by the total number of endotracheal suctioning throughout the period. Oxygen saturation values will be collected every minute during the 15 minutes post-suctioning. Endotracheal suctioning in patients already ventilated with 100% FiO2 started prior to the decision to aspirate will not be taken into account
Measured: from Day 0 to ventilator weaning, and at the latest Day 28
Secondary outcomes (19)
Suctioning rate leading to severe desaturation
It will be calculated for each patient as the number of suctioning leading to severe desaturation (SpO2 85% or less, and 80% or less for patients with COPD), divided by the total number of endotracheal suctioning throughout the period
Measured: From Day 0 to ventilator weaning, and at the latest Day 28
Number of ventilator free days at D28
Number of days without ventilation. In case of death value will be set to zero
Measured: From Day 0 to Day 28
Ventilator-associated pneumonia
Ventilator-associated pneumonia, as defined by the Formalized Recommendation of Experts from the SFAR-SRLF in 2017
Measured: From Day 0 to ICU-discharge, and at the latest Day 28
Intensive care delirium
Delirium occurring in ICU, defined by a positive result on the CAM-ICU clinical assessment tool specific to ICU delirium
Measured: From Day 0 to ICU-discharge, and at the latest Day 28
Composite criteria of ischemic phenomena in ICU, including one of the following: stroke, myocardial infarction, digestive ischemia
Composite criteria including at least one of the following: ischemic stroke, myocardial infarction, digestive ischemia
Measured: From Day 0 to ICU-discharge, and at the latest Day 28
Ischemic stroke
Ischemic stroke occurring in intensive care, defined by the combination of the onset of focal motor deficit and compatible cerebral imaging
Measured: From Day 0 to ICU-discharge, and at the latest Day 28
Myocardial infarction
Myocardial infarction occurring in intensive care, defined by an acute coronary syndrome with ST segment elevation and troponin elevation
Measured: From Day 0 to ICU-discharge, and at the latest Day 28
Digestive ischemia
Digestive ischemia occurring in intensive care, diagnosed by CT scan or digestive endoscopy
Measured: From Day 0 to ICU-discharge, and at the latest Day 28
Cardiac arrest
Cardiac arrest occuring in intensive care
Measured: From Day 0 to ICU-discharge, and at the latest Day 28
Acute kidney injury
Acute kidney injury occurring in intensive care, defined by the initiation of renal replacement therapy
Measured: From Day 0 to ICU-discharge, and at the latest Day 28
First bowel movements
Time to first bowel movements
Measured: From Day 0 to ICU-discharge, and at the latest Day 28
ICU discharge vital status
Vital status at discharge from ICU
Measured: At ICU discharge and at the latest Day 90
Hospital discharge vital status
Vital status at discharge from hospital
Measured: At hospital discharge, and at the latest Day 90
Mean saturation over 15 minutes post-suctioning
Mean saturation over all the period of 15 minutes post suctioning
Measured: From Day 0 to ventilator weaning, and at the latest Day 28
Absolute variation between saturation before suctioning and minimum saturation over 15 minutes post-suctioning
Saturation over all the period of 15 minutes post suctioning
Measured: From Day 0 to ventilator weaning, and at the latest Day 28
Acute respiratory distress syndrome (ARDS)
ARDS according to the Berlin definition, characterized by 1) acute respiratory failure evolving for a week or less, 2) bilateral opacities on thoracic imaging, 3) no evidence of predominant hydrostatic edema, 4) hypoxemia with a PaO2/FIO2 ratio < 300 mmHg for positive end-expiratory pressure set at 5 cmH2O or more, with 3 severity stages defined based on hypoxemia
Measured: From Day 0 to hospital discharge, and at the latest Day 90
Length of ICU stay
Length of stay in intensive care
Measured: at ICU discharge, and at the latest Day 90
Length of hospital stay
Length of stay in hospital
Measured: at hospital discharge, and at the latest Day 90
Time in minutes between endotracheal suctioning and eventual desaturation
For each desaturation, time in minutes between endotracheal suctioning and desaturation
Measured: From Day 0 to ventilator weaning, and at the latest Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2024
- Study start7 Jan 2025
- Primary completion10 Oct 2027 (estimated)
- Study completion10 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ICU Patients Under Invasive Mechanical VentilationStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 2,260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claire FAZILLEAU, Principal investigator, Hôpital Pitié Salpêtrière - Assistance Publique Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06421012
- Sponsor's protocol ID
- APHP230486
- Other IDs
- 2023-A00694-41
- Acronym
- POXTRA
- Status last verified
- May 2025
- First submitted
- 15 May 2024
- Last updated
- 11 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoxygenation for Tracheal Aspirations in Intensive Care, a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06421012
- Acronym / sponsor ID
- POXTRA / APHP230486
- Keywords
- Endotracheal suctioning, Preoxygenation, Ventilation, ICU
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,260 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 7 Jan 2025 (actual)
- Primary completion
- 10 Oct 2027 (estimated)
- Study completion
- 10 Dec 2027 (estimated)
- First posted
- 20 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.
Clearing the airways is a complex phenomenon involving the production of secretions, the nature of mucus (viscosity, elasticity, stringiness, and adhesiveness), ciliary movement, and coughing. In intubated and ventilated patients, endotracheal suctioning occur when the patient is "unable to clear the airways of obstructions hindering the free passage of air." These suctioning can lead to transient desaturation exacerbated by a decrease in cardiac output due to increased mean arterial pressure, promoting cardiac arrhythmias. To minimize these effects, it is recommended to perform additional preoxygenation, by increasing the fraction of O2 in the air delivered to the patient by the ventilator 2-3 minutes before the procedure. These longstanding recommendations were reiterated in 2022, based on outdated studies involving systematic suctioning that required disconnecting the patient from the ventilator.
Currently, suctioning are performed on-demand, based on the patient's congestion status, either through the endotracheal tube cap or a "closed system." Desaturations have become infrequent without establishing that additional preoxygenation can prevent them. Moreover, additional preoxygenation is not without risks. By inducing de-nitrogenation atelectasis with a loss of lung volume, it can exacerbate pre-existing lung injuries in the most severe patients. In less severe cases, preoxygenation leads to transient hyperoxia, with various deleterious effects impacting patient prognosis. Thus, a short-term risk, such as deep desaturations, must be balanced against a medium-term risk of hyperoxia and de-nitrogenation.
Detailed description
Clearing the airways is a complex phenomenon involving the production of secretions, the nature of mucus (viscosity, elasticity, stringiness, and adhesiveness), ciliary movement, and coughing. Endotracheal suctioning are performed when the patient is "unable to clear the airways of obstructions hindering the free passage of air." Classically, endotracheal suctioning cause transient desaturation exacerbated by a decrease in cardiac output due to an increase in mean arterial pressure, promoting cardiac arrhythmias. To minimize these effects, it is recommended to perform additional preoxygenation, i.e., increasing the fraction of O2 in the air delivered to the patient by the ventilator 2-3 minutes before the procedure. These longstanding recommendations were reiterated in 2022, based on outdated studies involving systematic suctioning and/or disconnecting the patient from the ventilator.
Today, suctioning are performed on-demand, based on the patient's congestion status, either through the endotracheal tube cap or a "closed system." Desaturations have become rare without establishing that additional preoxygenation can prevent them. Moreover, additional preoxygenation is not without risks. In the short term, it induces de-nitrogenation atelectasis resulting in a loss of lung volume that can worsen pre-existing lung injuries in the most severe patients. In less severe cases, preoxygenation is responsible for transient hyperoxia, with various deleterious effects impacting patient prognosis. Thus, a short-term risk, such as deep desaturations, is juxtaposed with a medium-term risk of hyperoxia and de-nitrogenation.
The investigators hypothesize that the absence of additional preoxygenation is not inferior, in terms of deep desaturations, to the strategy with additional preoxygenation, and it would avoid exposing patients to the risks of de-nitrogenation-induced atelectasis and hyperoxia.
The investigators retained a margin of non-inferiority for the relative risk of 1.1, i.e. an increase of 10% of deep desaturations.
The main analysis will be performed on the per-protocol population (more conservative in non-inferiority trials).The per-protocol population will include patients who had at least one suctioning and for whom the additional preoxygenation strategy allocated by randomisation was followed in at least 70% of all suctioning reported in the patient's care record. Patients who stopped their participation in the study before endpoint timeframe and those who had never had an suctioning will not be included in the per protocol population.
The unit of analysis will be the patient, and a rate of suctioning leading to deep desaturation will be calculated for each patient, as described in the primary endpoint. The mean rate of suctioning leading to deep desaturation will then be calculated by treatment group (with additional preoxygenation / without additional preoxygenation).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients without additional preoxygenation | Experimental | Procedure: Experimental : Patients without additional preoxygenation |
| Patients with additional preoxygenation | Active comparator | Procedure: Active Comparator : Patients with additional preoxygenation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age or older
- Hospitalized in ICU, under invasive mechanical ventilation for less than 24 hours
- Information and signature of consent by patient or relative/trusted person, or emergency inclusion procedure
Key exclusion criteria (6 listed)
- Patient on ECMO
- Not affiliated to a social security system
- Pregnant
- Under legal protection (curatorship, guardianship or safeguard of justice)
- Patient under AME
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 |
|---|---|---|
| Experimental : Patients without additional preoxygenationThroughout the entire period of their mechanical ventilation, patients will not receive additional preoxygenation before any endotracheal suctioning; their FiO2 value will be maintained constant | Procedure or surgery | Patients without additional preoxygenation |
| Active Comparator : Patients with additional preoxygenationThroughout the entire period of their mechanical ventilation, patients will receive additional preoxygenation at 100% FiO2 for a systematic 2-minute duration prior to any endotracheal suction. Subsequently, the FiO2 will be reset to the previous default value. | Procedure or surgery | Patients with additional preoxygenation |
Primary outcome
Rate of suctioning leading to deep desaturation
Time frame: from Day 0 to ventilator weaning, and at the latest Day 28
It will be calculated for each patient as the number of suctioning leading to deep desaturation (SpO2 88% or less, and 85% or less for patients with chronic obstructive pulmonary disease COPD), divided by the total number of endotracheal suctioning throughout the period. Oxygen saturation values will be collected every minute during the 15 minutes post-suctioning. Endotracheal suctioning in patients already ventilated with 100% FiO2 started prior to the decision to aspirate will not be taken into account
19 secondary outcomes
Suctioning rate leading to severe desaturation
Time frame: From Day 0 to ventilator weaning, and at the latest Day 28
Number of ventilator free days at D28
Time frame: From Day 0 to Day 28
Ventilator-associated pneumonia
Time frame: From Day 0 to ICU-discharge, and at the latest Day 28
Intensive care delirium
Time frame: From Day 0 to ICU-discharge, and at the latest Day 28
Composite criteria of ischemic phenomena in ICU, including one of the following: stroke, myocardial infarction, digestive ischemia
Time frame: From Day 0 to ICU-discharge, and at the latest Day 28
Ischemic stroke
Time frame: From Day 0 to ICU-discharge, and at the latest Day 28
Myocardial infarction
Time frame: From Day 0 to ICU-discharge, and at the latest Day 28
Digestive ischemia
Time frame: From Day 0 to ICU-discharge, and at the latest Day 28
Cardiac arrest
Time frame: From Day 0 to ICU-discharge, and at the latest Day 28
Acute kidney injury
Time frame: From Day 0 to ICU-discharge, and at the latest Day 28
First bowel movements
Time frame: From Day 0 to ICU-discharge, and at the latest Day 28
ICU discharge vital status
Time frame: At ICU discharge and at the latest Day 90
Hospital discharge vital status
Time frame: At hospital discharge, and at the latest Day 90
Mean saturation over 15 minutes post-suctioning
Time frame: From Day 0 to ventilator weaning, and at the latest Day 28
Absolute variation between saturation before suctioning and minimum saturation over 15 minutes post-suctioning
Time frame: From Day 0 to ventilator weaning, and at the latest Day 28
Acute respiratory distress syndrome (ARDS)
Time frame: From Day 0 to hospital discharge, and at the latest Day 90
Length of ICU stay
Time frame: at ICU discharge, and at the latest Day 90
Length of hospital stay
Time frame: at hospital discharge, and at the latest Day 90
Time in minutes between endotracheal suctioning and eventual desaturation
Time frame: From Day 0 to ventilator weaning, and at the latest Day 28
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 11 May 2025.
- Individual participant dataSharing planned: Yes. The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
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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.
Claire FAZILLEAU principal investigator
Hôpital Pitié Salpêtrière - Assistance Publique Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental : Patients without additional preoxygenation and Active Comparator : Patients with additional preoxygenation in people with ICU Patients Under Invasive Mechanical Ventilation, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 3 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: looking for participants now, as of the sponsor's last update on 11 May 2025. 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 France. 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?
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 Claire FAZILLEAU (01 42 16 22 75, claire.fazilleau@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of suctioning leading to deep desaturation (time frame: from Day 0 to ventilator weaning, and at the latest Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 May 2025.