DeliriumNCT03949114
Rehabilitation Intervention on Prevention of Postoperative Delirium
A study testing Evaluation, nursing care and rehabilitation in people with Delirium and Eras, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
1. A questionnaire on "Cognition and Attitudes of Nurses on Postoperative Deafness in Neurosurgical Patients" was initially formed through reference literature and expert opinions. The content includes two dimensions of knowledge and attitude, all of which are single-choice questions. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- What is being tested?
- Evaluation, nursing care and rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2019to 31 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with clear consciousness after neurosurgery craniotomy;
- Sign the research informed consent form.
Who cannot join
- Patients have a history of cognitive dysfunction, mental illness, senile dementia, and stroke before surgery;
- Patients and their families with poor behavioral compliance;
- Patients with drug dependence and alcohol dependence; -
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Hangzhou, Zhejiang
Minglan Zhu, master, 13757118731, 1161625519@qq.com
Qiuping Gu, Bachelor, 13777361958, 389612248@qq.com
About this study
Official title: Early Rehabilitation Intervention on Prevention of Postoperative Delirium in Neurosurgical Patients
- A questionnaire on "Cognition and Attitudes of Nurses on Postoperative Deafness in Neurosurgical Patients" was initially formed through reference literature and expert opinions. The content includes two dimensions of knowledge and attitude, all of which are single-choice questions. There are 11 items in the knowledge dimension, 1 point for the correct answer, 0 point for the wrong answer, and 0 to 11 points for the total score. The average score is the average score and the score of the score is the average score. The average score is ≤60%. Knowledge; attitude dimension is 7 items, using the Likert 4 rating method, "very disagree ~ very agree" count "1 to 4 points", total score 7 to 28 points. A sample questionnaire survey was conducted among non-severe unit nurses in the top three hospitals in the province to understand the level of cognitive mastery of the neurosurgical nurses in the province and the current status of interventions, and to compare the attitudes of nurses with different academic qualifications, years of work and work experience to postoperative intervention. And the level of knowledge mastery.
- Patients who underwent surgery on the neurosurgery in our hospital from December 31, 2010 to December 31, 2019 were used as the control group. After informed notification, the patients with the enrollment conditions were screened for Fried's debilitating phenotype and performed. Post-routine care; patients who underwent craniotomy in our department of neurosurgery from January 1, 2020 to June 31, 2020 were included in the intervention. Patients who met the criteria for admission were informed and informed consent was obtained. Develop an early rehabilitation process to guide patients to systematic early rehabilitation training. To compare the incidence of debilitating, sputum incidence (Nursing Delirium Screening Scale, Nu-DESC), sputum-related adverse events, Activity of Daily Living (ADL), patient satisfaction, etc. The clinical application effect of the early rehabilitation intervention system.
Read the detailed description
Research method: This project includes two parts of research.
Study 1:
1.1 Research object 1.1.1 Research population: 5 nurses in the top three hospitals in Zhejiang Province Exclusions: training nurses, rotation nurses, and nurses who have been working for <1 year.
1.1.2 Sample size: 80 people 1.2 Time: January 2019 - June 2019 1.3 Content
- Through self-designed questionnaires (see Attachment 1), the questionnaires cover the general information of the respondents including gender, age, working years, professional titles, academic qualifications, etc., including basic knowledge of postoperative sputum, and current preventive measures , knowledge needs and other aspects. The questionnaires on postoperative delirium knowledge were divided into two parts: subjective and objective. It mainly includes the concept of postoperative delirium, clinical manifestations, contents of nurses' evaluation form, diagnosis and treatment, risk factors and hazards. For the subjective and objective knowledge points, the choice is the main form.
- The questionnaire was distributed on the spot to 80 nurses in the top three hospitals in Zhejiang Province. The knowledge dimension consisted of 11 items. The correct answer was 1 point, the wrong score was 0 points, and the total score was 0 to 11 points. The percentage of points and full marks is taken as the average scoring rate. The average scoring rate is ≤60%, which means that the nurses fail to master the relevant knowledge; the attitude dimension is 7 items, and the Likert 4 level is used. "Very disagree~very agree" ~4 points", the total score is 7 to 28 points. The important information can not be filled out as a complete questionnaire.
- According to the working years of less than 3 years, 4 to 10 years, more than 10 years, the nursing staff can be divided into three levels: low, medium and high. The level of knowledge and attitude of the nursing staff at different levels are compared.
1.4 Method: Statistical analysis was performed using SPSS 22.0 software. The measurement data that conforms to the normal distribution is described by the mean value and the standard deviation, and the measurement data that does not conform to the normal distribution are described by the median and the interquartile range. The count data is described by a pie chart or a bar chart. In the stratified analysis, the comparison of the measurement data that conforms to the normal and the homogeneity of the variance is performed by t test or ANOVA. The comparison of the measurement data that does not conform to the normality or the homogeneity of the variance is performed by nonparametric test, and the comparison of the count data is performed by chi-square test. .
Study 2:
2.1. Research object 2.1.1 Study population: patients after neurosurgery 2.1.2 Research time: 2011.06-2020.06 2.1.3 Sample size: 300 people; 2.1.4 Inclusion criteria:
- Age ≥ 18 years old, <75 years old, gender is not limited;
- Those with clear consciousness after neurosurgery craniotomy;
- Sign the research informed consent form. 2.1.4 Exclusion criteria:
- The patient has a history of cognitive dysfunction, mental illness, senile dementia, and stroke before surgery; 2) Patients and their families with poor behavioral compliance; 3) Patients with drug dependence and alcohol dependence; 4) Serious postoperative complications (such as infection, bleeding, etc.). 2.1.5 Elimination criteria:
- Patients who have changed their condition during the study, or who have been transferred, discharged, and died.
2.2 Grouping method: During the period from June 1, 2019 to December 31, 2019, 150 patients with craniotomy who met the criteria and signed informed consent were included in the control group, from January 1, 2020 to June 30, 2020. During the period, 150 patients who met the standard neurosurgical craniotomy were included in the observation group.
2.3 Content:
(1) Performing a weak debilitating phenotype screening on the patients before surgery; (2) Patients in the control group were treated according to the general nursing routine after neurosurgery; (2) The observation group implements the early rehabilitation intervention process:
- Postoperative vital signs were stabilized for 2 hours and then assisted to turn over; 2 to 3 hours to change position, awake without swallowing dysfunction, to fluid diet; 6 hours later, raise the bed 15 to 30 °, eat a half-flow diet.
- On the first day after surgery, raise the bed 45 °, row and position training; catheter clamping training; assessment of pain, preventive analgesia. Early rehabilitation training was performed for 60 minutes each time for 5 consecutive days. The details are as follows:
- Active or passive assisted state of extension of the shoulder, elbow, ankle and knee joints to maximize the extent of movement of the distal extremity to prevent contracture. (10 minutes).
- Strength training (10 minutes) for the trunk and upper and lower limbs under active or passive assistance.
- Strengthen the functional training of the upper limbs and hand fine movements (15 minutes).
- Balance training, starting with the sitting position and gradually transitioning to the station position, especially after the patient can complete the standing movement (even in the case of assistance), strengthen the training of standing balance (10 minutes).
- Walk back and forth with assistance and gradually transition to walking back and forth (15 minutes) with only surveillance protection.
- From the second day after surgery to five days after surgery, daily daily life training, including washing, dressing, eating, etc. Walk 2 times a day for 30 minutes each time.
- The rest of the care is the same as general postoperative care routine. (4) Urgent treatment, once the patient is found to have timely treatment intervention, including drug and non-drug treatment.
2.4 Observation indicators and observation time 2.4.1 Observation time
- T1: return to the ward after surgery to 5 days after surgery;
- T2: at the time of discharge;
- T3: 1 week after discharge;
- T4: 1 month after discharge. 2.4.2 Observation indicators (1) T: Phase 1 MAIN OUTCOME MEASURES: Debilitating index, incidence of delirium. Secondary observation indicators: 谵妄 related adverse events (accident extubation, falls, etc.); (2) T2 phase: Postoperative hospital stay, hospitalization expenses, and activities of daily living activities, using the Barthel Index (BI), patient satisfaction (3) T3: the ability of daily living activities; (4) T4: activities of daily living activities
- Being tested
- Evaluation, nursing care, rehabilitation
- Keywords
- neurosurgery
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EvaluationBehavioural
Also called Fried assessment
Evaluate a weak debilitating phenotype screening on the patients before surgery;
nursing careBehavioural
Also called post-operative nursing care
Traditional post-operative nursing care
rehabilitationBehavioural
Also called ERAS
- Postoperative vital signs were stabilized for 2 hours and then assisted to turn over; 2 to 3 hours to change position, awake without swallowing dysfunction, to fluid diet; 6 hours later, raise the bed 15 to 30 °, eat a half-flow diet.
- On the first day after surgery, raise the bed 45 °, row and position training; catheter clamping training; assessment of pain, preventive analgesia. Early rehabilitation training was performed for 60 minutes each time for 5 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| test group | Experimental | 1) Performing a weak debilitating phenotype screening on the patients before surgery;
(2) Do the early rehabilitation intervention process: Receives: Behavioral: Evaluation; Behavioral: rehabilitation |
| Control group | Active comparator | 1) Performing a weak debilitating phenotype screening on the patients before surgery; (2) Patients in the control group were treated according to the general nursing routine after neurosurgery; Receives: Behavioral: Evaluation; Behavioral: nursing care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate of postoperative delirium
use the NU-DESC to assess every postoperative patients,to see the incidence of postoperative delirium
Measured: The first to fifth day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2019
- Study start1 May 2019
- Primary completion30 Jun 2021 (estimated)
- Study completion31 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeliriumStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- During the period from June 1, 2019 to December 31, 2019, 150 patients with craniotomy who met the criteria and signed informed consent were included in the control group, from January 1, 2020 to June 30, 2020. During the period, 150 patients who met the standard neurosurgical craniotomy were included in the observation group.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, zhuminglan, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03949114
- Sponsor's protocol ID
- 2019-022
- Status last verified
- May 2019
- First submitted
- 10 May 2019
- Last updated
- 14 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Rehabilitation Intervention on Prevention of Postoperative Delirium in Neurosurgical Patients
- ClinicalTrials.gov ID
- NCT03949114
- Acronym / sponsor ID
- 2019-022
- Keywords
- neurosurgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 31 Oct 2021 (estimated)
- First posted
- 14 May 2019 (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.
- A questionnaire on "Cognition and Attitudes of Nurses on Postoperative Deafness in Neurosurgical Patients" was initially formed through reference literature and expert opinions. The content includes two dimensions of knowledge and attitude, all of which are single-choice questions. There are 11 items in the knowledge dimension, 1 point for the correct answer, 0 point for the wrong answer, and 0 to 11 points for the total score. The average score is the average score and the score of the score is the average score. The average score is ≤60%. Knowledge; attitude dimension is 7 items, using the Likert 4 rating method, "very disagree ~ very agree" count "1 to 4 points", total score 7 to 28 points. A sample questionnaire survey was conducted among non-severe unit nurses in the top three hospitals in the province to understand the level of cognitive mastery of the neurosurgical nurses in the province and the current status of interventions, and to compare the attitudes of nurses with different academic qualifications, years of work and work experience to postoperative intervention. And the level of knowledge mastery.
- Patients who underwent surgery on the neurosurgery in our hospital from December 31, 2010 to December 31, 2019 were used as the control group. After informed notification, the patients with the enrollment conditions were screened for Fried's debilitating phenotype and performed. Post-routine care; patients who underwent craniotomy in our department of neurosurgery from January 1, 2020 to June 31, 2020 were included in the intervention. Patients who met the criteria for admission were informed and informed consent was obtained. Develop an early rehabilitation process to guide patients to systematic early rehabilitation training. To compare the incidence of debilitating, sputum incidence (Nursing Delirium Screening Scale, Nu-DESC), sputum-related adverse events, Activity of Daily Living (ADL), patient satisfaction, etc. The clinical application effect of the early rehabilitation intervention system.
Detailed description
Research method: This project includes two parts of research.
Study 1:
1.1 Research object 1.1.1 Research population: 5 nurses in the top three hospitals in Zhejiang Province Exclusions: training nurses, rotation nurses, and nurses who have been working for <1 year.
1.1.2 Sample size: 80 people 1.2 Time: January 2019 - June 2019 1.3 Content
- Through self-designed questionnaires (see Attachment 1), the questionnaires cover the general information of the respondents including gender, age, working years, professional titles, academic qualifications, etc., including basic knowledge of postoperative sputum, and current preventive measures , knowledge needs and other aspects. The questionnaires on postoperative delirium knowledge were divided into two parts: subjective and objective. It mainly includes the concept of postoperative delirium, clinical manifestations, contents of nurses' evaluation form, diagnosis and treatment, risk factors and hazards. For the subjective and objective knowledge points, the choice is the main form.
- The questionnaire was distributed on the spot to 80 nurses in the top three hospitals in Zhejiang Province. The knowledge dimension consisted of 11 items. The correct answer was 1 point, the wrong score was 0 points, and the total score was 0 to 11 points. The percentage of points and full marks is taken as the average scoring rate. The average scoring rate is ≤60%, which means that the nurses fail to master the relevant knowledge; the attitude dimension is 7 items, and the Likert 4 level is used. "Very disagree~very agree" ~4 points", the total score is 7 to 28 points. The important information can not be filled out as a complete questionnaire.
- According to the working years of less than 3 years, 4 to 10 years, more than 10 years, the nursing staff can be divided into three levels: low, medium and high. The level of knowledge and attitude of the nursing staff at different levels are compared.
1.4 Method: Statistical analysis was performed using SPSS 22.0 software. The measurement data that conforms to the normal distribution is described by the mean value and the standard deviation, and the measurement data that does not conform to the normal distribution are described by the median and the interquartile range. The count data is described by a pie chart or a bar chart. In the stratified analysis, the comparison of the measurement data that conforms to the normal and the homogeneity of the variance is performed by t test or ANOVA. The comparison of the measurement data that does not conform to the normality or the homogeneity of the variance is performed by nonparametric test, and the comparison of the count data is performed by chi-square test. .
Study 2:
2.1. Research object 2.1.1 Study population: patients after neurosurgery 2.1.2 Research time: 2011.06-2020.06 2.1.3 Sample size: 300 people; 2.1.4 Inclusion criteria:
- Age ≥ 18 years old, <75 years old, gender is not limited;
- Those with clear consciousness after neurosurgery craniotomy;
- Sign the research informed consent form. 2.1.4 Exclusion criteria:
- The patient has a history of cognitive dysfunction, mental illness, senile dementia, and stroke before surgery; 2) Patients and their families with poor behavioral compliance; 3) Patients with drug dependence and alcohol dependence; 4) Serious postoperative complications (such as infection, bleeding, etc.). 2.1.5 Elimination criteria:
- Patients who have changed their condition during the study, or who have been transferred, discharged, and died.
2.2 Grouping method: During the period from June 1, 2019 to December 31, 2019, 150 patients with craniotomy who met the criteria and signed informed consent were included in the control group, from January 1, 2020 to June 30, 2020. During the period, 150 patients who met the standard neurosurgical craniotomy were included in the observation group.
2.3 Content:
(1) Performing a weak debilitating phenotype screening on the patients before surgery; (2) Patients in the control group were treated according to the general nursing routine after neurosurgery; (2) The observation group implements the early rehabilitation intervention process:
- Postoperative vital signs were stabilized for 2 hours and then assisted to turn over; 2 to 3 hours to change position, awake without swallowing dysfunction, to fluid diet; 6 hours later, raise the bed 15 to 30 °, eat a half-flow diet.
- On the first day after surgery, raise the bed 45 °, row and position training; catheter clamping training; assessment of pain, preventive analgesia. Early rehabilitation training was performed for 60 minutes each time for 5 consecutive days. The details are as follows:
- Active or passive assisted state of extension of the shoulder, elbow, ankle and knee joints to maximize the extent of movement of the distal extremity to prevent contracture. (10 minutes).
- Strength training (10 minutes) for the trunk and upper and lower limbs under active or passive assistance.
- Strengthen the functional training of the upper limbs and hand fine movements (15 minutes).
- Balance training, starting with the sitting position and gradually transitioning to the station position, especially after the patient can complete the standing movement (even in the case of assistance), strengthen the training of standing balance (10 minutes).
- Walk back and forth with assistance and gradually transition to walking back and forth (15 minutes) with only surveillance protection.
- From the second day after surgery to five days after surgery, daily daily life training, including washing, dressing, eating, etc. Walk 2 times a day for 30 minutes each time.
- The rest of the care is the same as general postoperative care routine. (4) Urgent treatment, once the patient is found to have timely treatment intervention, including drug and non-drug treatment.
2.4 Observation indicators and observation time 2.4.1 Observation time
- T1: return to the ward after surgery to 5 days after surgery;
- T2: at the time of discharge;
- T3: 1 week after discharge;
- T4: 1 month after discharge. 2.4.2 Observation indicators (1) T: Phase 1 MAIN OUTCOME MEASURES: Debilitating index, incidence of delirium. Secondary observation indicators: 谵妄 related adverse events (accident extubation, falls, etc.); (2) T2 phase: Postoperative hospital stay, hospitalization expenses, and activities of daily living activities, using the Barthel Index (BI), patient satisfaction (3) T3: the ability of daily living activities; (4) T4: activities of daily living activities
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- During the period from June 1, 2019 to December 31, 2019, 150 patients with craniotomy who met the criteria and signed informed consent were included in the control group, from January 1, 2020 to June 30, 2020. During the period, 150 patients who met the standard neurosurgical craniotomy were included in the observation group.
| Arm | Type | Receives |
|---|---|---|
| test group | Experimental | Behavioral: Evaluation, Behavioral: rehabilitation1) Performing a weak debilitating phenotype screening on the patients before surgery; (2) Do the early rehabilitation intervention process: |
| Control group | Active comparator | Behavioral: Evaluation, Behavioral: nursing care1) Performing a weak debilitating phenotype screening on the patients before surgery; (2) Patients in the control group were treated according to the general nursing routine after neurosurgery; |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with clear consciousness after neurosurgery craniotomy;
- Sign the research informed consent form.
Key exclusion criteria (3 listed)
- Patients have a history of cognitive dysfunction, mental illness, senile dementia, and stroke before surgery;
- Patients and their families with poor behavioral compliance;
- Patients with drug dependence and alcohol dependence; -
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 |
|---|---|---|
| EvaluationAlso: Fried assessmentEvaluate a weak debilitating phenotype screening on the patients before surgery; | Behavioural | Control group, test group |
| nursing careAlso: post-operative nursing careTraditional post-operative nursing care | Behavioural | Control group |
| rehabilitationAlso: ERAS1. Postoperative vital signs were stabilized for 2 hours and then assisted to turn over; 2 to 3 hours to change position, awake without swallowing dysfunction, to fluid diet; 6 hours later, raise the bed 15 to 30 °, eat a half-flow diet. 2. On the first day after surgery, raise the bed 45 °, row and position training; catheter clamping training; assessment of pain, preventive analgesia. Early rehabilitation training was performed for 60 minutes each time for 5 consecutive days. | Behavioural | test group |
Primary outcome
Incidence rate of postoperative delirium
Time frame: The first to fifth day after surgery
use the NU-DESC to assess every postoperative patients,to see the incidence of postoperative delirium
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2019.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Evaluation, nursing care and rehabilitation in people with Delirium and Eras, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
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 3 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 14 May 2019. 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 China. 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 Minglan Zhu, master (13757118931 ext. 0571-87784713, 1161625519@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence rate of postoperative delirium (time frame: The first to fifth day after surgery). 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 14 May 2019; AzTrials last refreshed its copy on 7 Nov 2026.