Cognitive ImpairmentNCT02922634
Preoperative Cognitive Screening in Older Spinal Surgical Patients
An observational study of Cognitive Impairment and Frail Elderly Syndrome, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The objectives of this study are to determine whether identifying patients with baseline cognitive deficits or frailty predict postoperative delirium. Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cognitive Impairment, Frail Elderly Syndrome
- What is being tested?
- Mini Cog
- How many people
- 229 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Apr 2017to 9 Jun 2019
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: 229 consenting subjects ≥ 70 years of age who present to the BWH Weiner Center for Preoperative Evaluation (CPE) prior to elective spine surgery.
Who may be able to join
- patients 70 years of age and older presenting to the BWH Weiner Center for Preoperative Evaluation
- undergoing elective spine surgery
Who cannot join
- include planned ICU admission postoperatively
- history of stroke or brain tumor
- uncorrected vision or hearing impairment (unable to see pictures or read or hear instructions)
- limited use of the dominant hand (limited ability to draw)
- inability to speak, read, or understand English.
Trial locations and contacts
1 site in 1 country.
United States1 site
Weiner Center for Preoperative Evaluation
Boston, Massachusetts, 02115
About this study
Official title: Preoperative Cognitive Screening in Older Spinal Surgical Patients: Feasibility and Utility for Predicting Morbidity
The objectives of this study are to determine whether identifying patients with baseline cognitive deficits or frailty predict postoperative delirium.
Read the detailed description
This project is designed as a prospective, single-center observational study. The cohort will consist of 229 consenting subjects ≥ 70 years of age who present to the Brigham and Women's Hospital Weiner Center for Preoperative Evaluation (CPE) prior to elective spine surgery. These ages are chosen as significant clinical data demonstrate increased cognitive impairment in community dwelling elders. Eligibility criteria include: patients ≥ 70 years of age with an American Society of Anesthesiologists (ASA) physical status classification of I-III presenting for elective spine surgery. Exclusion criteria will include planned Intensive Care Unit (ICU) admission postoperatively, history of stroke or brain tumor, uncorrected vision or hearing impairment (unable to see pictures or read or hear instructions); limited use of the dominant hand (limited ability to draw); and or inability to speak, read, or understand English.
Patients will be introduced to the study through a flyer provided to them in their surgeon's office. A study team member will speak with those favorably predisposed to participate to determine if they satisfy eligibility criteria. After obtaining consent, study staff will gain information about the patient's age and years of education. Study staff will administer Health and functional status activities of daily living (ADLs) and instrumental activities of daily living (IADLs), respectively, and the World Health Organization Disability Assessment Scale [WHODAS]) will be administered to all surgical patients. The World Health Organization Disability Assessment Schedule 2.0 is an alternative to the 36-Item Rand Health Survey Short-Form (SF36) to measure physical health and disability. In addition, all patients will be asked if they've had a fall within the last 6 months, whether they've been evaluated for a change in memory or thinking, who accompanied them to their appointment, their employment status and their living situation (alone, institutionalized, living with family members) in a patient survey. The study staff will administer the MiniCog, a simple cognitive screening tool that takes just 2-4 min to complete and has little or no education, language, or race bias. In addition, the Animal Fluency test will be administered, which is a short cognitive screen that takes one minute to complete. Frailty will be measured using the Frail Scale. Other measures of cognitive impairment will be obtained by study staff through: documentation on the patient's standard preoperative form, patient or informant report of diagnosis or evaluation for cognitive impairment or memory concerns, and systematic medical record review. Each enrolled patient will receive a business card listing the investigators' contact information and be advised to expect a follow up telephone up to 6 and 12 months after surgery to verify data elements and reassess functional outcome.
Delirium will be assessed prospectively once per day on postoperative days 1, 2, and 3 if the patient remains hospitalized, by a trained study team member using the Confusion Assessment Method [CAM]. For patients that are in the Intensive Care Unit (ICU) postoperatively, the Confusion Assessment Method for the ICU (CAM-ICU) will be administered prospectively twice per day on postoperative days 1, 2, and 3 if the patient remains hospitalized by a trained study team member (Attachment-CAM-ICU). Delirium is most common on postoperative days 1-3 and the CAM is a well-validated measure of delirium in surgical patients. For functional status, the WHODAS will be administered 6-12 months postoperatively either by personnel in the surgeon's office as part of routine follow up or by study staff or by telephone. We will also collect information on secondary outcomes including discharge to place other than home (rehabilitation, skilled nursing facility), hospital length of stay (LOS), 30-day reoperation or readmission rate, and 30-day mortality. These outcomes are recorded in the medical record, the BWH Balanced Scorecard, an electronic database of all hospitalized patients that tabulates 31 elements of the hospital event, or the Brigham and Women's Hospital BWH Research Patient Database Enhanced Query. Data will also be confirmed by a follow up telephone interview.
- Conditions
- Cognitive Impairment, Frail Elderly Syndrome
- Being tested
- Mini Cog
- Keywords
- postoperative health outcomes, older surgical patients, delirium
- Medical subject headings
- Cognitive Dysfunction, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mini CogOther
Also called Frailty, Animal Fluency
short cognitive screen, short Frailty screen
| Study group | Role | What they receive |
|---|---|---|
| older surgical patients | Older surgical patients presenting for elective spine surgery Receives: Other: Mini Cog |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delirium by Age
The median ages of patients who did or did not develop post-operative delirium as assessed by the Confusion Assessment Method. The Confusion Assessment Method (CAM) is a short diagnostic interview for CAM-defined delirium. Delirium is defined as the sudden change in someone's thinking ability that can have devastating consequences and can be very easily missed due to its frequent subtlety. The 4 CAM features assessed by the CAM include: acute onset or fluctuation, inattention, disorganized thinking, or altered level of consciousness.
Measured: up to 3 days post-op
Number of Participants With or Without Delirium by Sex
Sex of patients who did or did not develop post-operative delirium as assessed by the Confusion Assessment Method.
Measured: up to 3 days post-op
Delirium by Body Mass Index
Median body mass index of patients who did or did not develop post-operative delirium as assessed by the Confusion Assessment Method.
Measured: up to 3 days post-op
Number of Participants With or Without Delirium by College Degree
Counts of patients with a college degree who did or did not develop post-operative delirium as assessed by the Confusion Assessment Method.
Measured: up to 3 days post-op
Participants With an ASA Physical Status Score and the Development of Postoperative Delirium
The ASA Physical Status Classification System assesses and communicates a patient's pre-anesthesia medical co-morbidities and is on a scale of I-VI. This study recruited patients with an ASA physical status of I-III. ASA I is defined as a normal healthy patient, ASA II is defined as a patient with a mild systemic disease, ASA III is defined as a patient with severe systemic disease. ASA physical status of patients who did or did not develop post-operative delirium as assessed by the Confusion Assessment Method.
Measured: up to 3 days post-op
Number of Participants With or Without Delirium by Metabolic Equivalent of Task Score < 4
Patients with a metabolic equivalent of task (METS) score < 4 who did or did not develop post-operative delirium as assessed by the Confusion Assessment Method. The METS score is a ratio of the working metabolic rate relative to the resting metabolic rate and is one way to describe the intensity of an exercise or activity. This was assessed by the preoperative or surgical study staff. A score of < 3 is for light intesity activities, 3-6 for moderate intensity activities, and ≥ 6 for vigorous intensity activities.
Measured: up to 3 days post-op
Delirium by Total Number of Medications Taken at Baseline
Median total number of medications of patients who did or did not develop post-operative delirium as assessed by the Confusion Assessment Method.
Measured: up to 3 days post-op
Number of Participants With or Without Delirium by Opioid Use
Patients with chronic use of opioids who did or did not develop post-operative delirium as assessed by the Confusion Assessment Method.
Measured: up to 3 days post-op
Number of Participants With or Without Delirium by Alcohol Consumption
Patients who did or did not develop post-operative delirium as assessed by the Confusion Assessment Method based on alcohol consumption.
Measured: up to 3 days post-op
Number of Participants With or Without Delirium by Presence of Depression
Patients with depression who did or did not develop post-operative delirium as assessed by the Confusion Assessment Method.
Measured: up to 3 days post-op
Number of Participants With or Without Delirium by Psychiatric History
Patients with a history of psychiatric disorders who did or did not develop post-operative delirium as assessed by the confusion assessment method.
Measured: up to 3 days post-op
Delirium by Mini-cog Score
Median mini-cog score of patients who did or did not develop post-operative delirium as assessed by the confusion assessment method. The Mini-Cog is a brief cognitive screening test for visuospatial representation, recall, and executive function. The test involves that includes recalling three words (banana, sunrise, and chair) and a clock drawing. The Mini-Cog has a scale from 0 to 5, a with higher scores suggesting better cognitive performance. One point is designated for each of 3 words recalled and up to two points for the clock drawing component.
Measured: up to 3 days post-op
Number of Participants With or Without Delirium by FRAIL Score
Robust, pre-frail, and frail patients who did or did not develop post-operative delirium as assessed by the confusion assessment method.
Measured: up to 3 days post-op
Number of Participants With or Without Delirium by Surgical Invasivness
Surgical invasiveness for patients who did or did not develop post-operative delirium as assessed by the confusion assessment method. The levels of invasiveness were categorized clinically as the following: Tier 1 for microdiscectomy, Tier 2 for lumbar laminectomy, anterior cervical, minimally invasive, foraminotomy, facetectomy, Tier 3 for lumbar fusion, trauma, and post-cervical, and Tier 4 for tumor, infection, deformity, and anterior and posterior cervical. Higher tiers indicate greater levels of invasiveness. Since there were very few patients with an invasiveness of 1 or 4 they were placed into two groups, with invasiveness levels I and 2 or 3 and 4.
Measured: up to 3 days post-op
Secondary outcomes (2)
Number of Participants With In-hospital Complications Were Observed During Their Length of Stay in the Hospital With Death Postoperative Death Monitored up to Day 30.
In hospital complications after the surgical procedure including: Myocardial Infarction, congestive heart failure (CHF), Cardiac Arrest, Arrythmia, Pneumonia, pulmonary embolism (PE), Reintubation, Stroke, Delirium, Coma>24h, deep wound infection,Superficial wound infection, Sepsis, Renal Failure, urinary tract infection (UTI), Reoperation, deep vein thrombosis (DVT), intensive care unit (ICU) admission,
Measured: duration of hospital stay, up to 30 days
Participants' Discharge Location (Home vs. Other Than Home)
Location where patients were discharged (Home vs other than home) on the day of patients discharge from the hospital.
Measured: up to 30 days after the surgical procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2016 (estimated)
- Study start17 Apr 2017
- Primary completion9 Oct 2018
- Study completion9 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 229 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deborah Culley, MD, Brigham and Women's Hospital
- Investigators
- Deborah Culley, M.D., Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02922634
- Sponsor's protocol ID
- 2016P000012
- Status last verified
- Jun 2021
- First submitted
- 14 Mar 2016
- Last updated
- 21 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Cognitive Screening in Older Spinal Surgical Patients: Feasibility and Utility for Predicting Morbidity
- ClinicalTrials.gov ID
- NCT02922634
- Acronym / sponsor ID
- 2016P000012
- Conditions
- Cognitive Impairment, Frail Elderly Syndrome
- Keywords
- postoperative health outcomes, older surgical patients, delirium
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 229 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 17 Apr 2017 (actual)
- Primary completion
- 9 Oct 2018 (actual)
- Study completion
- 9 Jun 2019 (actual)
- First posted
- 4 Oct 2016 (estimated)
- Results
- Posted 21 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives of this study are to determine whether identifying patients with baseline cognitive deficits or frailty predict postoperative delirium.
Detailed description
This project is designed as a prospective, single-center observational study. The cohort will consist of 229 consenting subjects ≥ 70 years of age who present to the Brigham and Women's Hospital Weiner Center for Preoperative Evaluation (CPE) prior to elective spine surgery. These ages are chosen as significant clinical data demonstrate increased cognitive impairment in community dwelling elders. Eligibility criteria include: patients ≥ 70 years of age with an American Society of Anesthesiologists (ASA) physical status classification of I-III presenting for elective spine surgery. Exclusion criteria will include planned Intensive Care Unit (ICU) admission postoperatively, history of stroke or brain tumor, uncorrected vision or hearing impairment (unable to see pictures or read or hear instructions); limited use of the dominant hand (limited ability to draw); and or inability to speak, read, or understand English.
Patients will be introduced to the study through a flyer provided to them in their surgeon's office. A study team member will speak with those favorably predisposed to participate to determine if they satisfy eligibility criteria. After obtaining consent, study staff will gain information about the patient's age and years of education. Study staff will administer Health and functional status activities of daily living (ADLs) and instrumental activities of daily living (IADLs), respectively, and the World Health Organization Disability Assessment Scale [WHODAS]) will be administered to all surgical patients. The World Health Organization Disability Assessment Schedule 2.0 is an alternative to the 36-Item Rand Health Survey Short-Form (SF36) to measure physical health and disability. In addition, all patients will be asked if they've had a fall within the last 6 months, whether they've been evaluated for a change in memory or thinking, who accompanied them to their appointment, their employment status and their living situation (alone, institutionalized, living with family members) in a patient survey. The study staff will administer the MiniCog, a simple cognitive screening tool that takes just 2-4 min to complete and has little or no education, language, or race bias. In addition, the Animal Fluency test will be administered, which is a short cognitive screen that takes one minute to complete. Frailty will be measured using the Frail Scale. Other measures of cognitive impairment will be obtained by study staff through: documentation on the patient's standard preoperative form, patient or informant report of diagnosis or evaluation for cognitive impairment or memory concerns, and systematic medical record review. Each enrolled patient will receive a business card listing the investigators' contact information and be advised to expect a follow up telephone up to 6 and 12 months after surgery to verify data elements and reassess functional outcome.
Delirium will be assessed prospectively once per day on postoperative days 1, 2, and 3 if the patient remains hospitalized, by a trained study team member using the Confusion Assessment Method [CAM]. For patients that are in the Intensive Care Unit (ICU) postoperatively, the Confusion Assessment Method for the ICU (CAM-ICU) will be administered prospectively twice per day on postoperative days 1, 2, and 3 if the patient remains hospitalized by a trained study team member (Attachment-CAM-ICU). Delirium is most common on postoperative days 1-3 and the CAM is a well-validated measure of delirium in surgical patients. For functional status, the WHODAS will be administered 6-12 months postoperatively either by personnel in the surgeon's office as part of routine follow up or by study staff or by telephone. We will also collect information on secondary outcomes including discharge to place other than home (rehabilitation, skilled nursing facility), hospital length of stay (LOS), 30-day reoperation or readmission rate, and 30-day mortality. These outcomes are recorded in the medical record, the BWH Balanced Scorecard, an electronic database of all hospitalized patients that tabulates 31 elements of the hospital event, or the Brigham and Women's Hospital BWH Research Patient Database Enhanced Query. Data will also be confirmed by a follow up telephone interview.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| older surgical patients | – | Other: Mini CogOlder surgical patients presenting for elective spine surgery |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- 229 consenting subjects ≥ 70 years of age who present to the BWH Weiner Center for Preoperative Evaluation (CPE) prior to elective spine surgery.
Key inclusion criteria (2 listed)
- patients 70 years of age and older presenting to the BWH Weiner Center for Preoperative Evaluation
- undergoing elective spine surgery
Key exclusion criteria (5 listed)
- include planned ICU admission postoperatively
- history of stroke or brain tumor
- uncorrected vision or hearing impairment (unable to see pictures or read or hear instructions)
- limited use of the dominant hand (limited ability to draw)
- inability to speak, read, or understand English.
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 |
|---|---|---|
| Mini CogAlso: Frailty, Animal Fluencyshort cognitive screen, short Frailty screen | Other | older surgical patients |
Primary outcome
Delirium by Age
Time frame: up to 3 days post-op
The median ages of patients who did or did not develop post-operative delirium as assessed by the Confusion Assessment Method. The Confusion Assessment Method (CAM) is a short diagnostic interview for CAM-defined delirium. Delirium is defined as the sudden change in someone's thinking ability that can have devastating consequences and can be very easily missed due to its frequent subtlety. The 4 CAM features assessed by the CAM include: acute onset or fluctuation, inattention, disorganized thinking, or altered level of consciousness.
Number of Participants With or Without Delirium by Sex
Time frame: up to 3 days post-op
Sex of patients who did or did not develop post-operative delirium as assessed by the Confusion Assessment Method.
Delirium by Body Mass Index
Time frame: up to 3 days post-op
Median body mass index of patients who did or did not develop post-operative delirium as assessed by the Confusion Assessment Method.
Number of Participants With or Without Delirium by College Degree
Time frame: up to 3 days post-op
Counts of patients with a college degree who did or did not develop post-operative delirium as assessed by the Confusion Assessment Method.
Participants With an ASA Physical Status Score and the Development of Postoperative Delirium
Time frame: up to 3 days post-op
The ASA Physical Status Classification System assesses and communicates a patient's pre-anesthesia medical co-morbidities and is on a scale of I-VI. This study recruited patients with an ASA physical status of I-III. ASA I is defined as a normal healthy patient, ASA II is defined as a patient with a mild systemic disease, ASA III is defined as a patient with severe systemic disease. ASA physical status of patients who did or did not develop post-operative delirium as assessed by the Confusion Assessment Method.
Number of Participants With or Without Delirium by Metabolic Equivalent of Task Score < 4
Time frame: up to 3 days post-op
Patients with a metabolic equivalent of task (METS) score < 4 who did or did not develop post-operative delirium as assessed by the Confusion Assessment Method. The METS score is a ratio of the working metabolic rate relative to the resting metabolic rate and is one way to describe the intensity of an exercise or activity. This was assessed by the preoperative or surgical study staff. A score of < 3 is for light intesity activities, 3-6 for moderate intensity activities, and ≥ 6 for vigorous intensity activities.
Delirium by Total Number of Medications Taken at Baseline
Time frame: up to 3 days post-op
Median total number of medications of patients who did or did not develop post-operative delirium as assessed by the Confusion Assessment Method.
Number of Participants With or Without Delirium by Opioid Use
Time frame: up to 3 days post-op
Patients with chronic use of opioids who did or did not develop post-operative delirium as assessed by the Confusion Assessment Method.
Number of Participants With or Without Delirium by Alcohol Consumption
Time frame: up to 3 days post-op
Patients who did or did not develop post-operative delirium as assessed by the Confusion Assessment Method based on alcohol consumption.
Number of Participants With or Without Delirium by Presence of Depression
Time frame: up to 3 days post-op
Patients with depression who did or did not develop post-operative delirium as assessed by the Confusion Assessment Method.
Number of Participants With or Without Delirium by Psychiatric History
Time frame: up to 3 days post-op
Patients with a history of psychiatric disorders who did or did not develop post-operative delirium as assessed by the confusion assessment method.
Delirium by Mini-cog Score
Time frame: up to 3 days post-op
Median mini-cog score of patients who did or did not develop post-operative delirium as assessed by the confusion assessment method. The Mini-Cog is a brief cognitive screening test for visuospatial representation, recall, and executive function. The test involves that includes recalling three words (banana, sunrise, and chair) and a clock drawing. The Mini-Cog has a scale from 0 to 5, a with higher scores suggesting better cognitive performance. One point is designated for each of 3 words recalled and up to two points for the clock drawing component.
Number of Participants With or Without Delirium by FRAIL Score
Time frame: up to 3 days post-op
Robust, pre-frail, and frail patients who did or did not develop post-operative delirium as assessed by the confusion assessment method.
Number of Participants With or Without Delirium by Surgical Invasivness
Time frame: up to 3 days post-op
Surgical invasiveness for patients who did or did not develop post-operative delirium as assessed by the confusion assessment method. The levels of invasiveness were categorized clinically as the following: Tier 1 for microdiscectomy, Tier 2 for lumbar laminectomy, anterior cervical, minimally invasive, foraminotomy, facetectomy, Tier 3 for lumbar fusion, trauma, and post-cervical, and Tier 4 for tumor, infection, deformity, and anterior and posterior cervical. Higher tiers indicate greater levels of invasiveness. Since there were very few patients with an invasiveness of 1 or 4 they were placed into two groups, with invasiveness levels I and 2 or 3 and 4.
2 secondary outcomes
Number of Participants With In-hospital Complications Were Observed During Their Length of Stay in the Hospital With Death Postoperative Death Monitored up to Day 30.
Time frame: duration of hospital stay, up to 30 days
Participants' Discharge Location (Home vs. Other Than Home)
Time frame: up to 30 days after the surgical procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Deborah Culley, M.D. principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cognitive Impairment and Frail Elderly Syndrome, run by Brigham and Women's Hospital at 1 site 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 2 inclusion and 5 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 21 Jul 2021. 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 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?
Yes. Results are posted in the registry (first posted 21 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Delirium by Age (time frame: up to 3 days post-op). The study lists 14 primary outcomes in all. 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 21 Jul 2021.