Delirium in Old AgeNCT04654962
Use of Anesthetic Block for the Prevention of in Hospital Delirium in Patients of the Orthogeriatric Clinical Care Center of the HUFSFB and HUSJI From 2019 - 2020
An observational study of Delirium in Old Age and Fragility Fracture, run by Fundación Santa Fe de Bogota at 1 site in Colombia.
Trial summary
The purpose of this study is to identify the association between analgesic management with blockade of the iliac fascia versus intravenous analgesia with the presence of delirium during hospital stay in patients admitted to the orthogeriatric clinical care center, to determine the opioid consumption of both groups of… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Delirium in Old Age, Fragility Fracture, Hip Fractures
- What is being tested?
- Anesthetic nerve block
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- How many people
- 160 participants
- Where
- 1 siteColombia
- Study dates
- 1 Oct 2020to 15 Feb 2021
- Phase
- Observational
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: * Patients older than 65 years with a diagnosis of hip fracture who are admitted to the Orthogeriatric Clinical Care Center at the Santa Fe de Bogotá Foundation in a period between January 2019 and December 2020. * Patients over 65 years of age with a diagnosis of hip fracture who enter the Excellence Program in Orthogeriatrics at the San José Infantil University Hospital in a period between January 2019 and December 2020.
Who may be able to join
- Patients over 65 years of age with a diagnosis of hip fracture due to fragility who are admitted to the Orthogeriatric clinical care center at the Santa Fe de Bogotá Foundation and the San José Infantil University Hospital between January 2019 and December 2020. These two institutions are selected Since they have a model of care for this type of patient, it is similar and therefore comparable.
Who cannot join
- Patients diagnosed with delirium on admission to the emergency room.
- Patients with hip fracture caused by high energy trauma
- Patients with hip fracture related with tumoral disease or metastasis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Anesthetic Block for the Prevention of in Hospital Delirium in Patients of the Orthogeriatric Clinical Care Center of the Fundacion Santa fe de Bogotá University Hospital and Infantil San Jose University Hospital From 2019 - 2020
The purpose of this study is to identify the association between analgesic management with blockade of the iliac fascia versus intravenous analgesia with the presence of delirium during hospital stay in patients admitted to the orthogeriatric clinical care center, to determine the opioid consumption of both groups of patients during hospitalization and determine the risk factors that may be associated with a greater presentation of delirium.
Read the detailed description
Nowadays, with the increase in the geriatric population, there is evidence of an increase in the prevalent conditions in this group, finding within them fragility hip fractures. Additionally, most of these patients have a large number of associated comorbidities, which may require greater specialization in care.
To reduce the possible complications that may be related, different management protocols have been implemented, including pain management strategies such as preventive analgesics, regional blocks, and early surgery. Conventional treatment with the use of intravenous medications can have unwanted effects in geriatric patients with hip fracture, especially in those with greater comorbidity, since medications such as opioids can cause multiple adverse effects, including delirium. Also, not treating pain properly can cause complications such as depression and ulcers in addition to delirium.
This is why the objective of this study is to define whether there is any association between the presentation of delirium in patients over 65 years of age with hip fracture who undergo iliac fascia block upon admission compared to those who receive only IV analgesia Therefore, this retrospective cohort study will be carried out with which it is sought to contribute to the knowledge to continue carrying out early pain management, with the aim of achieving better pain control, a decrease in opioid consumption and thus having a lower number of patients with delirium during hospitalization.
- Conditions
- Delirium in Old Age, Fragility Fracture, Hip Fractures
- Being tested
- Anesthetic nerve block
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anesthetic nerve blockProcedure or surgery
iliac fascia block is an analgesic technique that uses local anesthesia, is effective and relatively safe in preoperative management. The target of this block is the femoral and lateral femoral cutaneous nerves; which innervate the anterior aspect of the thigh, as well as the muscle and periosteum that covers the femoral head, neck and proximal femur.
| Study group | Role | What they receive |
|---|---|---|
| patients receiving preoperative analgesic management with anesthetic block | This cohort includes all patients that received preoperative anesthetic block for hip fracture surgery as main analgesic management during the study period. Receives: Procedure: Anesthetic nerve block | |
| patients receiving conventional preoperative analgesic management | This cohort includes all patients that received conventional preoperative analgesic management (oral, intravenous or intramuscular medication) for hip fracture surgery as main analgesic management during the study period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
In hospital Delirium
Presence of delirium measured with the Confusion Assessment Method (CAM) scale during hospitalization. The CAM scale assesses the presence and severity of delirium, and its algorithm is based on four main features of delirium: 1) acute onset and fluctuating course, 2) inattention, 3) disorganized thinking, and 4) altered level of consciousness. A diagnosis of delirium according to the CAM requires the presence of features 1, 2, and either 3 or 4.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2020
- Study start1 Oct 2020
- Primary completion15 Jan 2021 (estimated)
- Study completion15 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delirium in Old AgeStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Santa Fe de Bogota
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan Tihanyi Feldman, Fundación Santa Fe de Bogota
- Investigators
- Carlos M Olarte, MD, Principal investigator, Orthopedic surgeon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04654962
- Sponsor's protocol ID
- CEIS-2020-083
- Status last verified
- Dec 2020
- First submitted
- 25 Nov 2020
- Last updated
- 4 Dec 2020
- Results posted
- 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 4 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Anesthetic Block for the Prevention of in Hospital Delirium in Patients of the Orthogeriatric Clinical Care Center of the Fundacion Santa fe de Bogotá University Hospital and Infantil San Jose University Hospital From 2019 - 2020
- ClinicalTrials.gov ID
- NCT04654962
- Acronym / sponsor ID
- CEIS-2020-083
- Conditions
- Delirium in Old Age, Fragility Fracture, Hip Fractures
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Fundación Santa Fe de BogotaUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 15 Jan 2021 (estimated)
- Study completion
- 15 Feb 2021 (estimated)
- First posted
- 4 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 study is to identify the association between analgesic management with blockade of the iliac fascia versus intravenous analgesia with the presence of delirium during hospital stay in patients admitted to the orthogeriatric clinical care center, to determine the opioid consumption of both groups of patients during hospitalization and determine the risk factors that may be associated with a greater presentation of delirium.
Detailed description
Nowadays, with the increase in the geriatric population, there is evidence of an increase in the prevalent conditions in this group, finding within them fragility hip fractures. Additionally, most of these patients have a large number of associated comorbidities, which may require greater specialization in care.
To reduce the possible complications that may be related, different management protocols have been implemented, including pain management strategies such as preventive analgesics, regional blocks, and early surgery. Conventional treatment with the use of intravenous medications can have unwanted effects in geriatric patients with hip fracture, especially in those with greater comorbidity, since medications such as opioids can cause multiple adverse effects, including delirium. Also, not treating pain properly can cause complications such as depression and ulcers in addition to delirium.
This is why the objective of this study is to define whether there is any association between the presentation of delirium in patients over 65 years of age with hip fracture who undergo iliac fascia block upon admission compared to those who receive only IV analgesia Therefore, this retrospective cohort study will be carried out with which it is sought to contribute to the knowledge to continue carrying out early pain management, with the aim of achieving better pain control, a decrease in opioid consumption and thus having a lower number of patients with delirium during hospitalization.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients receiving preoperative analgesic management with anesthetic block | – | Procedure: Anesthetic nerve blockThis cohort includes all patients that received preoperative anesthetic block for hip fracture surgery as main analgesic management during the study period. |
| patients receiving conventional preoperative analgesic management | – | –This cohort includes all patients that received conventional preoperative analgesic management (oral, intravenous or intramuscular medication) for hip fracture surgery as main analgesic management during the study period. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- * Patients older than 65 years with a diagnosis of hip fracture who are admitted to the Orthogeriatric Clinical Care Center at the Santa Fe de Bogotá Foundation in a period between January 2019 and December 2020. * Patients over 65 years of age with a diagnosis of hip fracture who enter the Excellence Program in Orthogeriatrics at the San José Infantil University Hospital in a period between January 2019 and December 2020.
Key inclusion criteria (1 listed)
- Patients over 65 years of age with a diagnosis of hip fracture due to fragility who are admitted to the Orthogeriatric clinical care center at the Santa Fe de Bogotá Foundation and the San José Infantil University Hospital between January 2019 and December 2020. These two institutions are selected Since they have a model of care for this type of patient, it is similar and therefore comparable.
Key exclusion criteria (3 listed)
- Patients diagnosed with delirium on admission to the emergency room.
- Patients with hip fracture caused by high energy trauma
- Patients with hip fracture related with tumoral disease or metastasis
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 |
|---|---|---|
| Anesthetic nerve blockiliac fascia block is an analgesic technique that uses local anesthesia, is effective and relatively safe in preoperative management. The target of this block is the femoral and lateral femoral cutaneous nerves; which innervate the anterior aspect of the thigh, as well as the muscle and periosteum that covers the femoral head, neck and proximal femur. | Procedure or surgery | patients receiving preoperative analgesic management with anesthetic block |
Primary outcome
In hospital Delirium
Time frame: Through study completion, an average of 1 year
Presence of delirium measured with the Confusion Assessment Method (CAM) scale during hospitalization. The CAM scale assesses the presence and severity of delirium, and its algorithm is based on four main features of delirium: 1) acute onset and fluctuating course, 2) inattention, 3) disorganized thinking, and 4) altered level of consciousness. A diagnosis of delirium according to the CAM requires the presence of features 1, 2, and either 3 or 4.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2020.
- 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.
Carlos M Olarte, MD principal investigator
Orthopedic surgeon
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 Delirium in Old Age and Fragility Fracture, run by Fundación Santa Fe de Bogota at 1 site in Colombia.
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 1 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 4 Dec 2020. 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 Colombia. 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?
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?
In hospital Delirium (time frame: Through study completion, an average of 1 year). 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 4 Dec 2020.