Hypobaric HypoxiaHEMS IINCT05073406
Cognition at Altitude in HEMS - Part II
A study testing Altitude exposure in hypobaric normoxic condition and Altitude exposure in hypobaric hypoxic condition in people with Hypobaric Hypoxia and Hypobaric Normoxia, run by Institute of Mountain Emergency Medicine at 1 site in Italy.
Trial summary
The aim of the current study is to evaluate under blinded conditions, both in a simulated environment and during helicopter flight, the effect of a rapid (within 20 minutes) exposure to altitude (4000 m asl) on physiological parameters and selected cognitive domains, in providers operating in helicopter emergency… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypobaric Hypoxia, Hypobaric Normoxia, Cognitive Performance
- What is being tested?
- Altitude exposure in hypobaric normoxic condition and Altitude exposure in hypobaric hypoxic condition
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2021to 31 Dec 2022
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- members of emergency medical services (EMS) and search and rescue (SAR) services with an occupational licence;
- an age between 18 and 60 years;
- an American Society of Anaesthesiologists (ASA) physical status class I;
- provided informed and written consent;
- no current COVID 19 symptoms and temperature ≤ 37.5°on test days, not being tested positive for COVID-19, ideally COVID-19 vaccinated.
Who cannot join
- members under the age of 18 years;
- an ASA physical status class II or more;
- a medical history of psychiatric disorders and neurological diseases;
- previous high altitude pulmonary oedema (HAPE) or high altitude cerebral oedema (HACE) or severe acute mountain sickness (AMS) (defined as a Lake Louise Score (LLS) > 9) occurred at altitudes similar to the ones tested in the study;
- no informed consent;
- current COVID 19 symptoms, being tested positive for COVID-19 or symptoms and body temperature ≥ 37.5°on test days.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Eurac Research, Institute of Mountain Emergency Medicine
Bolzano, BZ, 39100
About this study
Official title: Cognitive Performance After Acute Exposure to Altitude - Part II
The aim of the current study is to evaluate under blinded conditions, both in a simulated environment and during helicopter flight, the effect of a rapid (within 20 minutes) exposure to altitude (4000 m asl) on physiological parameters and selected cognitive domains, in providers operating in helicopter emergency medical service (HEMS) exposed to hypobaric hypoxia or to hypobaric normoxia (H0: cognitive effects under hypobaric hypoxia = cognitive effects under hypobaric normoxia). Simulated environment will allow to control different factors. The parallelism between a study branch conducted in a simulated environment and another one conducted under a real-life condition will allow to evaluate the additive effects on additional stressor factors (processive and systemic ones).
- Simulation branch: each participant will take part in three research sessions: a familiarization session and two experimental sessions in simulation facility called terraXcube (test 1 and 2). On test 1 and test 2 each group will be exposed twice to the simulated altitude of 4000 m asl (under hypobaric hypoxia or hypobaric normoxia conditions) according to the randomization protocol. Participants will perform the neurocognitive tests three times on each of the two tests: before the ascent (TC0), after 5 min from the end of the ascent (TC1) and after around 30 min (TC2), to investigate European Union Aviation Safe Agency (EASA) proposed recommendations. After completing each neurocognitive test session, participants will be asked to rate their performance using a visual analogue scales (VAS). All participants will wear the vital parameters monitoring system during the entire duration of the tests inside the chamber, as well as the cerebral oxygen saturation (ScO2) sensor. Samples will be collected by saliva, urine and/or capillary blood. The same schedule is repeated in each test session.
- In-field branch: each participant will take part in three research sessions: a familiarization session and two experimental sessions during helicopter flights (test 1 and 2). On test 1 and test 2 each group will be exposed twice to the altitude of 4000 m (under hypobaric hypoxia or hypobaric normoxia conditions) according to the randomization protocol. Participants will perform the neurocognitive test two times on each test: before the ascent (TC0), after around 5 min from the end of the ascent (TC1). After completing each neurocognitive tests, participants will be asked to rate their performance using a visual analogue scales (VAS). All participants will wear the vital parameters monitoring system during the entire duration of the tests. Samples will be collected. The same schedule is planned in each test session.
- Conditions
- Hypobaric Hypoxia, Hypobaric Normoxia, Cognitive Performance, Emergency Medicine, Stress Physiology
- Being tested
- Altitude exposure in hypobaric normoxic condition, Altitude exposure in hypobaric hypoxic condition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Altitude exposure in hypobaric normoxic conditionOther
Altitude exposure with oxygen supplementation to achieve normoxia at altitude
Altitude exposure in hypobaric hypoxic conditionOther
Altitude exposure with air supplementation to obtain a sham comparator arm
| Study group | Role | What they receive |
|---|---|---|
| Hypobaric normoxia | Experimental | Altitude exposure in hypobaric normoxic condition Receives: Other: Altitude exposure in hypobaric normoxic condition |
| Hypobaric hypoxia | Sham comparator | Altitude exposure in hypobaric hypoxic condition Receives: Other: Altitude exposure in hypobaric hypoxic condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychomotor Vigilance Test - PVT
Changes in reaction time using a computer-based test (PVT)
Measured: Changes from baseline (T0) to altitude measurement (respectively after 5 min - T1 and after 30 min - T2)
Digit-Symbol Substitution Task - DSST
Changing in processing speed using a computer based test (DSST)
Measured: Changes from baseline (TC0) to altitude measurement (respectively after 5 min - TC1 and after 30 min - TC2)
2-back Test
Changing in working memory using a computer based test (2-back test)
Measured: Changes from baseline (TC0) to altitude measurement (respectively after 5 min - TC1 and after 30 min - TC2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2021
- Study start1 Sep 2021
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Hypobaric HypoxiaStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Interventional, non-pharmacological, randomized, controlled, double-blinded, cross-over
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Mountain Emergency Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- University Grenoble Alps, Università degli Studi di Trento, Medical University Innsbruck
- Responsible party
- Principal investigator, Giacomo Strapazzon, MD PhD, Institute of Mountain Emergency Medicine
- Investigators
- Giacomo Strapazzon, MD PhD, Principal investigator, Eurac Research, Institute of Mountain Emergency MedicineMarika Falla, MD PhD, Principal investigator, University of Trento, Center for Mind/Brain Sciences - CIMeCMichiel van Veelen, MD, Principal investigator, Eurac Research, Institute of Mountain Emergency Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05073406
- Sponsor's protocol ID
- 98-2021
- Acronym
- HEMS II
- Status last verified
- Jan 2023
- First submitted
- 29 Sep 2021
- Last updated
- 1 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Basner M, Moore TM, Nasrini J, Gur RC, Dinges DF. Standardization of psychomotor vigilance testing methods and reporting. Sleep. 2021 Jul 9;44(7):zsab114. doi: 10.1093/sleep/zsab114. No abstract available.
PubMed 34019081Brodmann Maeder M, Brugger H, Pun M, Strapazzon G, Dal Cappello T, Maggiorini M, Hackett P, Bartsch P, Swenson ER, Zafren K. The STAR Data Reporting Guidelines for Clinical High Altitude Research. High Alt Med Biol. 2018 Mar;19(1):7-14. doi: 10.1089/ham.2017.0160. Epub 2018 Feb 9.
PubMed 29596018Cable GG. In-flight hypoxia incidents in military aircraft: causes and implications for training. Aviat Space Environ Med. 2003 Feb;74(2):169-72.
PubMed 12602449EASA. https://www.easa.europa.eu/document-library/notices-of-proposed-amendment/npa-2018-04. (2018).
Falla M, Papagno C, Dal Cappello T, Vogele A, Hufner K, Kim J, Weiss EM, Weber B, Palma M, Mrakic-Sposta S, Brugger H, Strapazzon G. A Prospective Evaluation of the Acute Effects of High Altitude on Cognitive and Physiological Functions in Lowlanders. Front Physiol. 2021 Apr 28;12:670278. doi: 10.3389/fphys.2021.670278. eCollection 2021.
PubMed 33995130Falla M, Hufner K, Falk M, Weiss EM, Vogele A, Jan van Veelen M, Weber B, Brandner J, Palma M, Dejaco A, Brugger H, Strapazzon G. Simulated Acute Hypobaric Hypoxia Effects on Cognition in Helicopter Emergency Medical Service Personnel - A Randomized, Controlled, Single-Blind, Crossover Trial. Hum Factors. 2024 Feb;66(2):404-423. doi: 10.1177/00187208221086407. Epub 2022 May 31.
PubMed 35640630Hart, S., and Staveland, L. (1988). "Development of NASA-TLX (task load index) - results ofempirical and theoretical research," in HumanMental Workload, eds P. Hancock and N. Meshkati (Amsterdam: Springer), 139-183. doi: 10.1016/ s0166- 4115(08)62386- 9.
Hinkelbein J, Glaser E. Evaluation of two oxygen face masks with special regard to inspiratory oxygen fraction (FiO2) for emergency use in rescue helicopters. Air Med J. 2008 Mar-Apr;27(2):86-90. doi: 10.1016/j.amj.2007.07.005.
PubMed 18328973Mrakic-Sposta S, Vezzoli A, Malacrida S, Falla M, Strapazzon G. "Direct" and "Indirect" Methods to Detect Oxidative Stress During Acute or Chronic High-Altitude Exposure. High Alt Med Biol. 2017 Sep;18(3):303-304. doi: 10.1089/ham.2017.0067. Epub 2017 Jul 28. No abstract available.
PubMed 28753037Nowacki J, Heekeren HR, Deuter CE, Joerissen JD, Schroder A, Otte C, Wingenfeld K. Decision making in response to physiological and combined physiological and psychosocial stress. Behav Neurosci. 2019 Feb;133(1):59-67. doi: 10.1037/bne0000288. Epub 2018 Dec 17.
PubMed 30556701Wilson MH, Newman S, Imray CH. The cerebral effects of ascent to high altitudes. Lancet Neurol. 2009 Feb;8(2):175-91. doi: 10.1016/S1474-4422(09)70014-6.
PubMed 19161909Falla M, van Veelen MJ, Falk M, Weiss EM, Roveri G, Mase M, Weber B, Randi A, Brugger H, Hufner K, Strapazzon G. Effect of oxygen supplementation on cognitive performance among HEMS providers after acute exposure to altitude: the HEMS II randomized clinical trial. Scand J Trauma Resusc Emerg Med. 2024 Jul 29;32(1):65. doi: 10.1186/s13049-024-01238-6.
PubMed 39075543
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Performance After Acute Exposure to Altitude - Part II
- ClinicalTrials.gov ID
- NCT05073406
- Acronym / sponsor ID
- HEMS II / 98-2021
- Conditions
- Hypobaric Hypoxia, Hypobaric Normoxia, Cognitive Performance, Emergency Medicine, Stress Physiology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Institute of Mountain Emergency MedicineUniversity, hospital or other
- Collaborators
- University Grenoble Alps, Università degli Studi di Trento, Medical University Innsbruck
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 11 Oct 2021 (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.
The aim of the current study is to evaluate under blinded conditions, both in a simulated environment and during helicopter flight, the effect of a rapid (within 20 minutes) exposure to altitude (4000 m asl) on physiological parameters and selected cognitive domains, in providers operating in helicopter emergency medical service (HEMS) exposed to hypobaric hypoxia or to hypobaric normoxia (H0: cognitive effects under hypobaric hypoxia = cognitive effects under hypobaric normoxia). Simulated environment will allow to control different factors. The parallelism between a study branch conducted in a simulated environment and another one conducted under a real-life condition will allow to evaluate the additive effects on additional stressor factors (processive and systemic ones).
- Simulation branch: each participant will take part in three research sessions: a familiarization session and two experimental sessions in simulation facility called terraXcube (test 1 and 2). On test 1 and test 2 each group will be exposed twice to the simulated altitude of 4000 m asl (under hypobaric hypoxia or hypobaric normoxia conditions) according to the randomization protocol. Participants will perform the neurocognitive tests three times on each of the two tests: before the ascent (TC0), after 5 min from the end of the ascent (TC1) and after around 30 min (TC2), to investigate European Union Aviation Safe Agency (EASA) proposed recommendations. After completing each neurocognitive test session, participants will be asked to rate their performance using a visual analogue scales (VAS). All participants will wear the vital parameters monitoring system during the entire duration of the tests inside the chamber, as well as the cerebral oxygen saturation (ScO2) sensor. Samples will be collected by saliva, urine and/or capillary blood. The same schedule is repeated in each test session.
- In-field branch: each participant will take part in three research sessions: a familiarization session and two experimental sessions during helicopter flights (test 1 and 2). On test 1 and test 2 each group will be exposed twice to the altitude of 4000 m (under hypobaric hypoxia or hypobaric normoxia conditions) according to the randomization protocol. Participants will perform the neurocognitive test two times on each test: before the ascent (TC0), after around 5 min from the end of the ascent (TC1). After completing each neurocognitive tests, participants will be asked to rate their performance using a visual analogue scales (VAS). All participants will wear the vital parameters monitoring system during the entire duration of the tests. Samples will be collected. The same schedule is planned in each test session.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Interventional, non-pharmacological, randomized, controlled, double-blinded, cross-over
| Arm | Type | Receives |
|---|---|---|
| Hypobaric normoxia | Experimental | Other: Altitude exposure in hypobaric normoxic conditionAltitude exposure in hypobaric normoxic condition |
| Hypobaric hypoxia | Sham comparator | Other: Altitude exposure in hypobaric hypoxic conditionAltitude exposure in hypobaric hypoxic condition |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- members of emergency medical services (EMS) and search and rescue (SAR) services with an occupational licence;
- an age between 18 and 60 years;
- an American Society of Anaesthesiologists (ASA) physical status class I;
- provided informed and written consent;
- no current COVID 19 symptoms and temperature ≤ 37.5°on test days, not being tested positive for COVID-19, ideally COVID-19 vaccinated.
Key exclusion criteria (6 listed)
- members under the age of 18 years;
- an ASA physical status class II or more;
- a medical history of psychiatric disorders and neurological diseases;
- previous high altitude pulmonary oedema (HAPE) or high altitude cerebral oedema (HACE) or severe acute mountain sickness (AMS) (defined as a Lake Louise Score (LLS) > 9) occurred at altitudes similar to the ones tested in the study;
- no informed consent;
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 |
|---|---|---|
| Altitude exposure in hypobaric normoxic conditionAltitude exposure with oxygen supplementation to achieve normoxia at altitude | Other | Hypobaric normoxia |
| Altitude exposure in hypobaric hypoxic conditionAltitude exposure with air supplementation to obtain a sham comparator arm | Other | Hypobaric hypoxia |
Primary outcome
Psychomotor Vigilance Test - PVT
Time frame: Changes from baseline (T0) to altitude measurement (respectively after 5 min - T1 and after 30 min - T2)
Changes in reaction time using a computer-based test (PVT)
Digit-Symbol Substitution Task - DSST
Time frame: Changes from baseline (TC0) to altitude measurement (respectively after 5 min - TC1 and after 30 min - TC2)
Changing in processing speed using a computer based test (DSST)
2-back Test
Time frame: Changes from baseline (TC0) to altitude measurement (respectively after 5 min - TC1 and after 30 min - TC2)
Changing in working memory using a computer based test (2-back test)
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 1 Mar 2023.
- Background: PubMed 34019081Basner M, Moore TM, Nasrini J, Gur RC, Dinges DF. Standardization of psychomotor vigilance testing methods and reporting. Sleep. 2021 Jul 9;44(7):zsab114. doi: 10.1093/sleep/zsab114. No abstract available.
- Background: PubMed 29596018Brodmann Maeder M, Brugger H, Pun M, Strapazzon G, Dal Cappello T, Maggiorini M, Hackett P, Bartsch P, Swenson ER, Zafren K. The STAR Data Reporting Guidelines for Clinical High Altitude Research. High Alt Med Biol. 2018 Mar;19(1):7-14. doi: 10.1089/ham.2017.0160. Epub 2018 Feb 9.
- Background: PubMed 12602449Cable GG. In-flight hypoxia incidents in military aircraft: causes and implications for training. Aviat Space Environ Med. 2003 Feb;74(2):169-72.
- BackgroundEASA. https://www.easa.europa.eu/document-library/notices-of-proposed-amendment/npa-2018-04. (2018).
- Background: PubMed 33995130Falla M, Papagno C, Dal Cappello T, Vogele A, Hufner K, Kim J, Weiss EM, Weber B, Palma M, Mrakic-Sposta S, Brugger H, Strapazzon G. A Prospective Evaluation of the Acute Effects of High Altitude on Cognitive and Physiological Functions in Lowlanders. Front Physiol. 2021 Apr 28;12:670278. doi: 10.3389/fphys.2021.670278. eCollection 2021.
- Background: PubMed 35640630Falla M, Hufner K, Falk M, Weiss EM, Vogele A, Jan van Veelen M, Weber B, Brandner J, Palma M, Dejaco A, Brugger H, Strapazzon G. Simulated Acute Hypobaric Hypoxia Effects on Cognition in Helicopter Emergency Medical Service Personnel - A Randomized, Controlled, Single-Blind, Crossover Trial. Hum Factors. 2024 Feb;66(2):404-423. doi: 10.1177/00187208221086407. Epub 2022 May 31.
- BackgroundHart, S., and Staveland, L. (1988). "Development of NASA-TLX (task load index) - results ofempirical and theoretical research," in HumanMental Workload, eds P. Hancock and N. Meshkati (Amsterdam: Springer), 139-183. doi: 10.1016/ s0166- 4115(08)62386- 9.
- Background: PubMed 18328973Hinkelbein J, Glaser E. Evaluation of two oxygen face masks with special regard to inspiratory oxygen fraction (FiO2) for emergency use in rescue helicopters. Air Med J. 2008 Mar-Apr;27(2):86-90. doi: 10.1016/j.amj.2007.07.005.
- Background: PubMed 28753037Mrakic-Sposta S, Vezzoli A, Malacrida S, Falla M, Strapazzon G. "Direct" and "Indirect" Methods to Detect Oxidative Stress During Acute or Chronic High-Altitude Exposure. High Alt Med Biol. 2017 Sep;18(3):303-304. doi: 10.1089/ham.2017.0067. Epub 2017 Jul 28. No abstract available.
- Background: PubMed 30556701Nowacki J, Heekeren HR, Deuter CE, Joerissen JD, Schroder A, Otte C, Wingenfeld K. Decision making in response to physiological and combined physiological and psychosocial stress. Behav Neurosci. 2019 Feb;133(1):59-67. doi: 10.1037/bne0000288. Epub 2018 Dec 17.
- Background: PubMed 19161909Wilson MH, Newman S, Imray CH. The cerebral effects of ascent to high altitudes. Lancet Neurol. 2009 Feb;8(2):175-91. doi: 10.1016/S1474-4422(09)70014-6.
- Derived from this study: PubMed 39075543Falla M, van Veelen MJ, Falk M, Weiss EM, Roveri G, Mase M, Weber B, Randi A, Brugger H, Hufner K, Strapazzon G. Effect of oxygen supplementation on cognitive performance among HEMS providers after acute exposure to altitude: the HEMS II randomized clinical trial. Scand J Trauma Resusc Emerg Med. 2024 Jul 29;32(1):65. doi: 10.1186/s13049-024-01238-6.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giacomo Strapazzon, MD PhD principal investigator
Eurac Research, Institute of Mountain Emergency Medicine
Marika Falla, MD PhD principal investigator
University of Trento, Center for Mind/Brain Sciences - CIMeC
Michiel van Veelen, MD principal investigator
Eurac Research, Institute of Mountain Emergency Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Altitude exposure in hypobaric normoxic condition and Altitude exposure in hypobaric hypoxic condition in people with Hypobaric Hypoxia and Hypobaric Normoxia, run by Institute of Mountain Emergency Medicine at 1 site in Italy.
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 5 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: finished, as of the sponsor's last update on 1 Mar 2023. 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 Italy. 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. Some participants in this study may receive a placebo. 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?
Psychomotor Vigilance Test - PVT (time frame: Changes from baseline (T0) to altitude measurement (respectively after 5 min - T1 and after 30 min - T2)). The study lists 3 primary outcomes in all. 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 NCT05073406, which also lists 12 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 Mar 2023.