Acute Compartment SyndromeNCT04671173
Real-Time Muscle Pressure Measurements in Patients at Risk for Acute Compartment Syndrome
A study testing Measurement of the Intra-Compartmental Pressure with the MY01 device in people with Acute Compartment Syndrome, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 2 sites in United States.
Trial summary
The purpose of this trial is to conduct a pilot study that will aid in the design of an evaluation of the clinical benefit of MY01, an FDA cleared device, that allows continuous monitoring of intracompartmental muscle pressure in patients at risk for developing acute compartment syndrome. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Compartment Syndrome
- What is being tested?
- Measurement of the Intra-Compartmental Pressure with the MY01 device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 Mar 2022to 31 Mar 2023
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Direct admission to hospital from scene of injury, or if transferred, admitted no more than 12 hours from injury
- High-energy fracture of the tibial plateau (bicondylar or medial fracture - dislocation)
- High energy displaced tibial diaphysis (highly comminuted or segmental fracture, or proximal third of tibia (e.g. GSW to the proximal fibula)) that is felt by the surgeon to have a likelihood of elevated ICP and risk of ACS.
Who cannot join
- Frankly contaminated or infected wounds or fractures.
- Clinical suspicion of acute compartment syndrome requiring urgent fasciotomy at time of presentation to study center.
- Monitoring could not be initiated within 12 hours of presentation
- Acute or pre-existing neuropathy in the study limb.
- Patient is pregnant
- Patient is a prisoner/incarcerated
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Not yet recruiting
Hennepin County Medical Center - Orthopaedic Research
Minneapolis, Minnesota, 55414
Jerald Westberg, 612-873-4634, jerald.westberg@hcmed.org
Andrew H Schmidt, MD
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Karen M Trochez, 615-936-0347, karen.m.trochez@vumc.org
William T Obremskey, MD
About this study
Official title: Real-Time Muscle Pressure Measurements in Patients at Risk for Acute Compartment Syndrome: A Prospective Cohort Study With Historical Control
The purpose of this trial is to conduct a pilot study that will aid in the design of an evaluation of the clinical benefit of MY01, an FDA cleared device, that allows continuous monitoring of intracompartmental muscle pressure in patients at risk for developing acute compartment syndrome. MY01 has previously been successfully tested on animal and Human cadaver Acute Compartment Syndrome models within the RI MUHC through Department of Defense research Grant (Combat Casualty Care Research Program (CCCRP). This trial is supported by the same grant, as the next phase of the overall project.
This is a multi-center, non-randomized, historically controlled, prospective trial of the MY01 device. A cohort of 50 participants will be prospectively enrolled with two weeks follow up to document clinical benefit of the device. Results from this study will be used to inform the design of a larger study designed to demonstrate the clinical benefit of the MY01 device in the early diagnosis of ACS.
Read more
The role of each organisation within the trial are detailed below:
- Research Institute of McGill University Health Centre (RI MUHC): study coordination and data analysis (no recruitment activity will take place in the MUHC).
- Hennepin Healthcare: participants recruitment
- Vanderbilt University Medical Centre: participants recruitment
Read the detailed description
Research Plan
The purpose of this trial is to conduct a pilot study that will inform the design of a trial to evaluate the clinical benefit of MY01, a FDA cleared device that allows continuous monitoring of intracompartmental muscle pressure in patients at risk for developing acute compartment syndrome. The MY01 device is a digitally connected device with a companion mobile app designed to continuously monitor intracompartmental pressure, outputting the results to the mobile app, where clinicians can track the pressure in real time.
There are several goals of this study. Fifty patients with high-energy injuries to the proximal leg and tibial shaft will be prospectively studied and compared to a cohort of historical controls. We want to evaluate the feasibility of collecting data related to the diagnosis of ACS and the measurement of its associated complications. We will also use this data to attempt to assign a modified Boyers grade to a cohort of prospectively enrolled patients and historical controls. Clinical validation of the modified Boyers grade will represent a large step forward in compartment syndrome research, since it will bring an objective assessment of severity to the diagnosis of acute compartment syndrome.
These control patients are to be obtained from several cohorts of patients:
1- Data collected for 3 Retrospective studies on tibial fractures and dislocations resulting in acute compartment syndrome completed in Montreal General Hospital, Vanderbilt University Health Centre and Hennepin Healthcare. The data received from those existing studies will be de-identified.
2 - Patients treated in the PACS study previously funded by DOD and run by METRC.
3- Trauma Quality Programs Participant Use File (TQP) data.
Another goal is to assess the reoperation rates, for limb salvage or amputation among patients that undergo continuous monitoring of ICP using the MY01 monitor relative to a cohort of historical controls who did not receive continuous monitoring.
Primary Research Outcome
Assess the reoperation rate and number of operative procedures for all surgically managed acute compartment syndrome patients.
Secondary Research Outcomes
There are numerous outcomes that are related to the severity of ACS when it is diagnosed. This study will also assess our ability to identify the following secondary outcomes among a cohort of prospectively enrolled patients relative to a cohort of historical controls.
- Comparison of grades of ACS to the historic controls.
- Increased proportion of lower ACS outcome grades (Grades 1,2 as per grade)
- Reduction in time to diagnosis of ACS
- Improved short-term visual analog pain scores (VAS) for pain in affected limb
- Reduction in inpatient days
- Reduction in Skin Grafts
- Reduction in Major Myectomy
- Reduction in Anesthesia Time for patients undergoing fasciotomy
- Clinical ease with which the new compartment pressure monitor was inserted into a muscle compartment, per satisfaction survey.
- Conditions
- Acute Compartment Syndrome
- Being tested
- Measurement of the Intra-Compartmental Pressure with the MY01 device
- Keywords
- Acute compartment syndrome, minimally invasive, sensor, intracompartmental muscle pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of the Intra-Compartmental Pressure with the MY01 deviceDevice
All Participants will be monitored for clinical signs of symptoms of ACS, including the 7 Ps at a minimum of every 4-6 hours.
The Intra-Compartmental Pressure of the anterior compartment of the leg will be monitored with the MY01 device. The device should be inserted five centimeters (5 cm) from the fracture, if possible, in the muscle belly. The affected limb will then be splinted in a standard U-slab with no pressure on the monitored device.
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm (only one arm) | Experimental | Only one arm, the participants will all received the device to measure Intra-compartmental pressure after consenting to study participation. Receives: Device: Measurement of the Intra-Compartmental Pressure with the MY01 device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reoperation rate (number of re-operation)
Assess the reoperation rate for all surgically managed acute compartment syndrome patients following the original fasciotomy.
Measured: 6 weeks
Number of operative procedures
Number of operative procedures for all surgically managed acute compartment syndrome patients.
Measured: 6 weeks
Secondary outcomes (9)
Comparison of grades of ACS to the historic controls.
Comparison of grades of ACS to the historic controls.
Measured: 6 weeks
Changed proportion of lower ACS outcome grades
changed proportion of lower ACS outcome grades (Grades 1,2 as per grade)
Measured: 6 weeks
Change in time to diagnosis of ACS
Measured: 6 weeks
Change in short-term visual analog pain scores (VAS) for pain in affected limb
Measured: 6 weeks
Change in inpatient days
Measured: 6 weeks
Change in Skin Grafts number
Measured: 6 weeks
change in Major Myectomy number
Measured: 6 weeks
change in Anesthesia Time for patients undergoing fasciotomy
Measured: 6 weeks
Clinician satisfaction survey (percentage)
Clinical ease with which the new compartment pressure monitor was inserted into a muscle compartment, per satisfaction survey.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start18 Mar 2022
- Primary completion15 Feb 2023 (estimated)
- Study completion31 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Acute Compartment SyndromeStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- multi-center, non-randomized, historically controlled, prospective pilot trial of the MY01 device.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense, Hennepin Healthcare Research Institute, Vanderbilt University Medical Center
- Responsible party
- Principal investigator, Mitchell Bernstein, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Mitchell Bernstein, Dr, Principal investigator, Research Institute of McGill University Health Centre (RI MUHC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04671173
- Sponsor's protocol ID
- 2021-6655
- Status last verified
- Apr 2022
- First submitted
- 8 Dec 2020
- Last updated
- 12 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No IPD will be shared to other researchers
Publications
Via AG, Oliva F, Spoliti M, Maffulli N. Acute compartment syndrome. Muscles Ligaments Tendons J. 2015 Mar 27;5(1):18-22. eCollection 2015 Jan-Mar.
PubMed 25878982Shadgan B, Menon M, Sanders D, Berry G, Martin C Jr, Duffy P, Stephen D, O'Brien PJ. Current thinking about acute compartment syndrome of the lower extremity. Can J Surg. 2010 Oct;53(5):329-34.
PubMed 20858378McQueen MM, Gaston P, Court-Brown CM. Acute compartment syndrome. Who is at risk? J Bone Joint Surg Br. 2000 Mar;82(2):200-3.
PubMed 10755426Collinge CA, Attum B, Lebus GF, Tornetta P 3rd, Obremskey W, Ahn J, Mirick G, Schmidt A, Spitler C, Coles C, Krause P; Orthopaedic Trauma Association's Evidence-based Quality and Value Committee. Acute Compartment Syndrome: An Expert Survey of Orthopaedic Trauma Association Members. J Orthop Trauma. 2018 May;32(5):e181-e184. doi: 10.1097/BOT.0000000000001128.
PubMed 29432322Schmidt AH, Bosse MJ, Frey KP, O'Toole RV, Stinner DJ, Scharfstein DO, Zipunnikov V, MacKenzie EJ; METRC. Predicting Acute Compartment Syndrome (PACS): The Role of Continuous Monitoring. J Orthop Trauma. 2017 Apr;31 Suppl 1:S40-S47. doi: 10.1097/BOT.0000000000000796.
PubMed 28323801Shadgan B, Pereira G, Menon M, Jafari S, Darlene Reid W, O'Brien PJ. Risk factors for acute compartment syndrome of the leg associated with tibial diaphyseal fractures in adults. J Orthop Traumatol. 2015 Sep;16(3):185-92. doi: 10.1007/s10195-014-0330-y. Epub 2014 Dec 28.
PubMed 25543232McQueen MM, Court-Brown CM. Compartment monitoring in tibial fractures. The pressure threshold for decompression. J Bone Joint Surg Br. 1996 Jan;78(1):99-104.
PubMed 8898137
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-Time Muscle Pressure Measurements in Patients at Risk for Acute Compartment Syndrome: A Prospective Cohort Study With Historical Control
- ClinicalTrials.gov ID
- NCT04671173
- Acronym / sponsor ID
- 2021-6655
- Conditions
- Acute Compartment Syndrome
- Keywords
- Acute compartment syndrome, minimally invasive, sensor, intracompartmental muscle pressure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Collaborators
- United States Department of Defense, Hennepin Healthcare Research Institute, Vanderbilt University Medical Center
- Study start
- 18 Mar 2022 (actual)
- Primary completion
- 15 Feb 2023 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 17 Dec 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.
The purpose of this trial is to conduct a pilot study that will aid in the design of an evaluation of the clinical benefit of MY01, an FDA cleared device, that allows continuous monitoring of intracompartmental muscle pressure in patients at risk for developing acute compartment syndrome. MY01 has previously been successfully tested on animal and Human cadaver Acute Compartment Syndrome models within the RI MUHC through Department of Defense research Grant (Combat Casualty Care Research Program (CCCRP). This trial is supported by the same grant, as the next phase of the overall project.
This is a multi-center, non-randomized, historically controlled, prospective trial of the MY01 device. A cohort of 50 participants will be prospectively enrolled with two weeks follow up to document clinical benefit of the device. Results from this study will be used to inform the design of a larger study designed to demonstrate the clinical benefit of the MY01 device in the early diagnosis of ACS.
The role of each organisation within the trial are detailed below:
- Research Institute of McGill University Health Centre (RI MUHC): study coordination and data analysis (no recruitment activity will take place in the MUHC).
- Hennepin Healthcare: participants recruitment
- Vanderbilt University Medical Centre: participants recruitment
Detailed description
Research Plan
The purpose of this trial is to conduct a pilot study that will inform the design of a trial to evaluate the clinical benefit of MY01, a FDA cleared device that allows continuous monitoring of intracompartmental muscle pressure in patients at risk for developing acute compartment syndrome. The MY01 device is a digitally connected device with a companion mobile app designed to continuously monitor intracompartmental pressure, outputting the results to the mobile app, where clinicians can track the pressure in real time.
There are several goals of this study. Fifty patients with high-energy injuries to the proximal leg and tibial shaft will be prospectively studied and compared to a cohort of historical controls. We want to evaluate the feasibility of collecting data related to the diagnosis of ACS and the measurement of its associated complications. We will also use this data to attempt to assign a modified Boyers grade to a cohort of prospectively enrolled patients and historical controls. Clinical validation of the modified Boyers grade will represent a large step forward in compartment syndrome research, since it will bring an objective assessment of severity to the diagnosis of acute compartment syndrome.
These control patients are to be obtained from several cohorts of patients:
1- Data collected for 3 Retrospective studies on tibial fractures and dislocations resulting in acute compartment syndrome completed in Montreal General Hospital, Vanderbilt University Health Centre and Hennepin Healthcare. The data received from those existing studies will be de-identified.
2 - Patients treated in the PACS study previously funded by DOD and run by METRC.
3- Trauma Quality Programs Participant Use File (TQP) data.
Another goal is to assess the reoperation rates, for limb salvage or amputation among patients that undergo continuous monitoring of ICP using the MY01 monitor relative to a cohort of historical controls who did not receive continuous monitoring.
Primary Research Outcome
Assess the reoperation rate and number of operative procedures for all surgically managed acute compartment syndrome patients.
Secondary Research Outcomes
There are numerous outcomes that are related to the severity of ACS when it is diagnosed. This study will also assess our ability to identify the following secondary outcomes among a cohort of prospectively enrolled patients relative to a cohort of historical controls.
- Comparison of grades of ACS to the historic controls.
- Increased proportion of lower ACS outcome grades (Grades 1,2 as per grade)
- Reduction in time to diagnosis of ACS
- Improved short-term visual analog pain scores (VAS) for pain in affected limb
- Reduction in inpatient days
- Reduction in Skin Grafts
- Reduction in Major Myectomy
- Reduction in Anesthesia Time for patients undergoing fasciotomy
- Clinical ease with which the new compartment pressure monitor was inserted into a muscle compartment, per satisfaction survey.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- multi-center, non-randomized, historically controlled, prospective pilot trial of the MY01 device.
| Arm | Type | Receives |
|---|---|---|
| Experimental arm (only one arm) | Experimental | Device: Measurement of the Intra-Compartmental Pressure with the MY01 deviceOnly one arm, the participants will all received the device to measure Intra-compartmental pressure after consenting to study participation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Direct admission to hospital from scene of injury, or if transferred, admitted no more than 12 hours from injury
- High-energy fracture of the tibial plateau (bicondylar or medial fracture - dislocation)
- High energy displaced tibial diaphysis (highly comminuted or segmental fracture, or proximal third of tibia (e.g. GSW to the proximal fibula)) that is felt by the surgeon to have a likelihood of elevated ICP and risk of ACS.
Key exclusion criteria (6 listed)
- Frankly contaminated or infected wounds or fractures.
- Clinical suspicion of acute compartment syndrome requiring urgent fasciotomy at time of presentation to study center.
- Monitoring could not be initiated within 12 hours of presentation
- Acute or pre-existing neuropathy in the study limb.
- Patient is pregnant
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 |
|---|---|---|
| Measurement of the Intra-Compartmental Pressure with the MY01 deviceAll Participants will be monitored for clinical signs of symptoms of ACS, including the 7 Ps at a minimum of every 4-6 hours. The Intra-Compartmental Pressure of the anterior compartment of the leg will be monitored with the MY01 device. The device should be inserted five centimeters (5 cm) from the fracture, if possible, in the muscle belly. The affected limb will then be splinted in a standard U-slab with no pressure on the monitored device. | Device | Experimental arm (only one arm) |
Primary outcome
Reoperation rate (number of re-operation)
Time frame: 6 weeks
Assess the reoperation rate for all surgically managed acute compartment syndrome patients following the original fasciotomy.
Number of operative procedures
Time frame: 6 weeks
Number of operative procedures for all surgically managed acute compartment syndrome patients.
9 secondary outcomes
Comparison of grades of ACS to the historic controls.
Time frame: 6 weeks
Changed proportion of lower ACS outcome grades
Time frame: 6 weeks
Change in time to diagnosis of ACS
Time frame: 6 weeks
Change in short-term visual analog pain scores (VAS) for pain in affected limb
Time frame: 6 weeks
Change in inpatient days
Time frame: 6 weeks
Change in Skin Grafts number
Time frame: 6 weeks
change in Major Myectomy number
Time frame: 6 weeks
change in Anesthesia Time for patients undergoing fasciotomy
Time frame: 6 weeks
Clinician satisfaction survey (percentage)
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2022.
- Background: PubMed 25878982Via AG, Oliva F, Spoliti M, Maffulli N. Acute compartment syndrome. Muscles Ligaments Tendons J. 2015 Mar 27;5(1):18-22. eCollection 2015 Jan-Mar.
- Background: PubMed 20858378Shadgan B, Menon M, Sanders D, Berry G, Martin C Jr, Duffy P, Stephen D, O'Brien PJ. Current thinking about acute compartment syndrome of the lower extremity. Can J Surg. 2010 Oct;53(5):329-34.
- Background: PubMed 10755426McQueen MM, Gaston P, Court-Brown CM. Acute compartment syndrome. Who is at risk? J Bone Joint Surg Br. 2000 Mar;82(2):200-3.
- Background: PubMed 29432322Collinge CA, Attum B, Lebus GF, Tornetta P 3rd, Obremskey W, Ahn J, Mirick G, Schmidt A, Spitler C, Coles C, Krause P; Orthopaedic Trauma Association's Evidence-based Quality and Value Committee. Acute Compartment Syndrome: An Expert Survey of Orthopaedic Trauma Association Members. J Orthop Trauma. 2018 May;32(5):e181-e184. doi: 10.1097/BOT.0000000000001128.
- Background: PubMed 28323801Schmidt AH, Bosse MJ, Frey KP, O'Toole RV, Stinner DJ, Scharfstein DO, Zipunnikov V, MacKenzie EJ; METRC. Predicting Acute Compartment Syndrome (PACS): The Role of Continuous Monitoring. J Orthop Trauma. 2017 Apr;31 Suppl 1:S40-S47. doi: 10.1097/BOT.0000000000000796.
- Background: PubMed 25543232Shadgan B, Pereira G, Menon M, Jafari S, Darlene Reid W, O'Brien PJ. Risk factors for acute compartment syndrome of the leg associated with tibial diaphyseal fractures in adults. J Orthop Traumatol. 2015 Sep;16(3):185-92. doi: 10.1007/s10195-014-0330-y. Epub 2014 Dec 28.
- Background: PubMed 8898137McQueen MM, Court-Brown CM. Compartment monitoring in tibial fractures. The pressure threshold for decompression. J Bone Joint Surg Br. 1996 Jan;78(1):99-104.
- Individual participant dataSharing planned: No. No IPD will be shared to other researchers
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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.
Mitchell Bernstein, Dr principal investigator
Research Institute of McGill University Health Centre (RI MUHC)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Measurement of the Intra-Compartmental Pressure with the MY01 device in people with Acute Compartment Syndrome, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 2 sites in United States.
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: status not confirmed, as of the sponsor's last update on 12 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anne Mathiot (5149341934, anne.mathiot@muhc.mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reoperation rate (number of re-operation) (time frame: 6 weeks). The study lists 2 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 NCT04671173, which also lists 7 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 12 Apr 2022.