Femoral FractureNCT01647230
Cerebral Oxygenation and Spinal Anaesthesia in Elderly Patients With Hip Fracture
An observational study of Femoral Fracture and Blood Pressure, run by Hospital de Sabadell at 1 site in Spain.
Trial summary
The aim of this study is to observe how the hemodynamic changes induced by spinal blockade affect cerebral oxygenation. Elderly patients are very frail. Hypotension is very frequent during spinal anaesthesia. Bradycardia is other side effect of regional anaesthesia affecting cardiac output and cerebral blood flow. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Femoral Fracture, Blood Pressure, Cognitive Impairment
- How many people
- 70 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2012to Feb 2013
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients aged > 70 years old with hip fracture undergoing surgery under spinal anaesthesia.
Who may be able to join
- Patients aged >70 years old with hip fracture.
- No contraindication for spinal anaesthesia.
Who cannot join
- Allergic reaction to local anesthetics.
- Severe aortic stenosis.
- Local infection.
- SPMSQ test >7 errors.
- Patient refusal
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital de Sabadell - CSPT
Barcelona, Sabadell, 08208
Diana L Fernández Galinski, PhD, 0034937231010 ext. 21277, DFernandez@tauli.cat
Francisca Gordo Lacal, Dr, 0034937231010 ext. 21277, fgordo@tauli.cat
About this study
Official title: Observational Study of Cerebral Oxygenation and Spinal Anaesthesia in Elderly Patients With Hip Fracture
The aim of this study is to observe how the hemodynamic changes induced by spinal blockade affect cerebral oxygenation. Elderly patients are very frail. Hypotension is very frequent during spinal anaesthesia. Bradycardia is other side effect of regional anaesthesia affecting cardiac output and cerebral blood flow. These complications of spinal anaesthesia could decline cognitive function. In this way a non invasive monitoring technique as cerebral oximetry is useful for the safety of anesthetic procedure.
Read the detailed description
Patients aged 70 years old with hip fracture presenting for surgical repair under intrathecal anaesthesia performed with bupivacaine or L bupivacaine (dose 7 - 9 mg). Preoperative haemoglobin and drugs consumption are registered. All patients receive supplemental oxygen during surgery. Cerebral oximetry, blood pressure, heart rate and oxygen arterial saturation are measured. Level and duration of sensory and motor block are registered. The study observes if there is any correlation between cerebral oximetry and these hemodynamic parameters.
The investigators also observe if there is any correlation between cerebral oximetry and cognitive function evaluated pre and postoperatively by SPMSQ test.
Postoperative SPMSQ test will be performed on the 5th postoperative day and the complications registered.Patients will be followed for the duration of acute hospital stay.
- Conditions
- Femoral Fracture, Blood Pressure, Cognitive Impairment
- Keywords
- Anaesthesia, spinal, Cerebral oximetry, Blood pressure, Heart rate, Cognitive Symptom
- Medical subject headings
- Femoral Fractures, Cognitive Dysfunction, Neurobehavioral Manifestations
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral Oximetry
Changes in cerebral oxymetry measured initially (basal), 10, 20 and 30 minutes after spinal block. During surgery oximetry is measured evey 10 minutes to obtain the mean of all the values.
Measured: Initial, 3 times after spinal block and every 10 minutes during surgery
Mean Arterial Pressure (MAP)
Changes in MAP measured initially (basal), 10, 20 and 30 minutes after spinal block. During surgery oximetry is measured every 10 minutes to obtain the mean of all the values
Measured: Initial, 3 times after spinal block and every 10 minutes during surgery
Heart Rate (HR)
Changes in HR (basal), 10, 20 and 30 minutes after spinal block. During surgery oximetry is measured every 10 minutes to obtain the mean of all the values.
Measured: Initial, 3 times after spinal block and every 10 minutes during surgery
Oxygen arterial saturation (OSat)
Changes in OSat measured initially (basal), 10, 20 and 30 minutes after spinal block. During surgery oximetry is measured every 10 minutes to obtain the mean of all the values.
Measured: Initial, 3 times after spinal block and every 10 minutes during surgery
Secondary outcomes (1)
Short Portable Mental Status Questionnaire (SPMSQ)
This test measures cognitive impairment before and after surgery
Measured: Once before surgery and at 5th postoperative day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2012 (estimated)
- Study startFeb 2012
- Study completionFeb 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoral FractureStudies 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
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Sabadell
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diana L Fernandez Galinski, Hospital de Sabadell
- Investigators
- Diana L Fernández Galinski, PhD, Principal investigator, Hospital de Sabadell - CSPT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01647230
- Sponsor's protocol ID
- 2011612CSPT
- Status last verified
- Jul 2012
- First submitted
- 19 Jul 2012
- Last updated
- 25 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Cerebral Oxygenation and Spinal Anaesthesia in Elderly Patients With Hip Fracture
- ClinicalTrials.gov ID
- NCT01647230
- Acronym / sponsor ID
- 2011612CSPT
- Conditions
- Femoral Fracture, Blood Pressure, Cognitive Impairment
- Keywords
- Anaesthesia, spinal, Cerebral oximetry, Blood pressure, Heart rate, Cognitive Symptom
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Hospital de SabadellUniversity, hospital or other
- Study start
- Feb 2012
- Study completion
- Feb 2013 (estimated)
- First posted
- 23 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to observe how the hemodynamic changes induced by spinal blockade affect cerebral oxygenation. Elderly patients are very frail. Hypotension is very frequent during spinal anaesthesia. Bradycardia is other side effect of regional anaesthesia affecting cardiac output and cerebral blood flow. These complications of spinal anaesthesia could decline cognitive function. In this way a non invasive monitoring technique as cerebral oximetry is useful for the safety of anesthetic procedure.
Detailed description
Patients aged 70 years old with hip fracture presenting for surgical repair under intrathecal anaesthesia performed with bupivacaine or L bupivacaine (dose 7 - 9 mg). Preoperative haemoglobin and drugs consumption are registered. All patients receive supplemental oxygen during surgery. Cerebral oximetry, blood pressure, heart rate and oxygen arterial saturation are measured. Level and duration of sensory and motor block are registered. The study observes if there is any correlation between cerebral oximetry and these hemodynamic parameters.
The investigators also observe if there is any correlation between cerebral oximetry and cognitive function evaluated pre and postoperatively by SPMSQ test.
Postoperative SPMSQ test will be performed on the 5th postoperative day and the complications registered.Patients will be followed for the duration of acute hospital stay.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients aged > 70 years old with hip fracture undergoing surgery under spinal anaesthesia.
Key inclusion criteria (2 listed)
- Patients aged >70 years old with hip fracture.
- No contraindication for spinal anaesthesia.
Key exclusion criteria (5 listed)
- Allergic reaction to local anesthetics.
- Severe aortic stenosis.
- Local infection.
- SPMSQ test >7 errors.
- Patient refusal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cerebral Oximetry
Time frame: Initial, 3 times after spinal block and every 10 minutes during surgery
Changes in cerebral oxymetry measured initially (basal), 10, 20 and 30 minutes after spinal block. During surgery oximetry is measured evey 10 minutes to obtain the mean of all the values.
Mean Arterial Pressure (MAP)
Time frame: Initial, 3 times after spinal block and every 10 minutes during surgery
Changes in MAP measured initially (basal), 10, 20 and 30 minutes after spinal block. During surgery oximetry is measured every 10 minutes to obtain the mean of all the values
Heart Rate (HR)
Time frame: Initial, 3 times after spinal block and every 10 minutes during surgery
Changes in HR (basal), 10, 20 and 30 minutes after spinal block. During surgery oximetry is measured every 10 minutes to obtain the mean of all the values.
Oxygen arterial saturation (OSat)
Time frame: Initial, 3 times after spinal block and every 10 minutes during surgery
Changes in OSat measured initially (basal), 10, 20 and 30 minutes after spinal block. During surgery oximetry is measured every 10 minutes to obtain the mean of all the values.
1 secondary outcome
Short Portable Mental Status Questionnaire (SPMSQ)
Time frame: Once before surgery and at 5th postoperative day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2012.
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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.
Diana L Fernández Galinski, PhD principal investigator
Hospital de Sabadell - CSPT
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 Femoral Fracture and Blood Pressure, run by Hospital de Sabadell at 1 site in Spain.
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: status not confirmed, as of the sponsor's last update on 25 Jul 2012. 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 Spain. 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 Diana L Fernández Galinski, PhD (0034937231010 ext. 21277, DFernandez@tauli.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebral Oximetry (time frame: Initial, 3 times after spinal block and every 10 minutes during surgery). The study lists 4 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 25 Jul 2012.