Patients Aged 55 or OlderNCT01570491
A Real-Time Ultrasound Guided Approach For Spinal Anesthesia
A study testing ultrasound-guided spinal anesthesia and standard spinal anesthesia in people with Patients Aged 55 or Older and BMI More Than 40 kg/m2, run by The Cleveland Clinic at 1 site in United States.
Trial summary
Our goal was to compare the number of attempts to perform spinal anesthesia using real-time ultrasound guidance versus landmark technique in patients meeting predefined criteria for difficult spinal anesthesia. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Patients Aged 55 or Older, BMI More Than 40 kg/m2, Scoliosis
- What is being tested?
- ultrasound-guided spinal anesthesia and standard spinal anesthesia
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Dec 2016
- Phase
- Interventional
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 55 or older
- BMI more than 40
- Scoliosis
Who cannot join
- 1 Patients who have undergone previous Spine Surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cardiothoracic Anesthesia and Critical Care Patient Registry
Our goal was to compare the number of attempts to perform spinal anesthesia using real-time ultrasound guidance versus landmark technique in patients meeting predefined criteria for difficult spinal anesthesia.
Read the detailed description
Patients who consent to receive spinal anesthesia (as opposed to some other anesthetic technique) and who meet the inclusion/exclusion criteria for the study (given below) will be randomized on day of surgery after obtaining informed consent to either ultrasound-guided or standard spinal anesthesia technique.
A block randomization scheme with random block sizes ranging from 2-8 patients will be used. The outcomes will be recorded by a third party observer in the block room/operating room who might be a nurse or resident or clinical research fellow not directly involved with performing the block. The post procedure outcomes will also be recorded by a clinical research fellow or resident who was not directly involved with performing the block.
No sample size estimation methodology currently exists for the right-censored count data models. We expect less number of attempts in the ultrasound group a 20 % difference between the two groups which we feel is a minimum of a clinically-relevant effect. At the 0.05 level of significance with a power of 0.8, we will require a minimum of 20 patients per group,therefore we plan to recruit 40 patients in total.
The analysis will be conducted by a statistician who will be blinded.
- Conditions
- Patients Aged 55 or Older, BMI More Than 40 kg/m2, Scoliosis
- Being tested
- ultrasound-guided spinal anesthesia, standard spinal anesthesia
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound-guided spinal anesthesiaOther
ultrasound-guided technique for block placement
standard spinal anesthesiaOther
Anesthesiologist will use standard technique for placement of spinal block.
| Study group | Role | What they receive |
|---|---|---|
| ultrasound-guided spinal anesthesia | Active comparator | participants will randomly assigned to use ultrasound-guided technique for block placement by Anesthesiologist. Receives: Other: ultrasound-guided spinal anesthesia |
| standard spinal anesthesia | Placebo comparator | randomized participants will be given standard spinal anesthesia insertion technique for block placement by Anesthesiologist Receives: Other: standard spinal anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Attempts
Number of attempts (defined as number of needle reinsertions form the skin and NOT number of redirection of the needle) at the beginning of surgery
Measured: 10-15 minutes before the surgery
Secondary outcomes (3)
Difficulty of Block Insertion
Difficulty of insertion, was rated by the performing anesthesiologist on a 10-point Likert scale from one (easy) to ten (extremely difficult)
Measured: 10-15 minutes before the surgery
Patient Satisfaction
Record patient satisfaction on a five-point Likert scale, where a value of 1 indicates extremely unsatisfied and a value of 5 indicates extremely satisfied.
Measured: after insert the block but before the surgery
Time to Perform Block (Second)
Time to perform block (from first needle insertion to injection of medication)
Measured: as measured in seconds after needle insertion, surgical date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2012 (estimated)
- Study startMar 2012
- Primary completionDec 2016
- Study completionDec 2016
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 Patients Aged 55 or OlderStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hesham Elsharkawy, M.D., Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01570491
- Sponsor's protocol ID
- 11-1171
- Status last verified
- Jul 2019
- First submitted
- 27 Mar 2012
- Last updated
- 26 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiothoracic Anesthesia and Critical Care Patient Registry
- ClinicalTrials.gov ID
- NCT01570491
- Acronym / sponsor ID
- 11-1171
- Conditions
- Patients Aged 55 or Older, BMI More Than 40 kg/m2, Scoliosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Mar 2012 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 4 Apr 2012 (estimated)
- Results
- Posted 26 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Our goal was to compare the number of attempts to perform spinal anesthesia using real-time ultrasound guidance versus landmark technique in patients meeting predefined criteria for difficult spinal anesthesia.
Detailed description
Patients who consent to receive spinal anesthesia (as opposed to some other anesthetic technique) and who meet the inclusion/exclusion criteria for the study (given below) will be randomized on day of surgery after obtaining informed consent to either ultrasound-guided or standard spinal anesthesia technique.
A block randomization scheme with random block sizes ranging from 2-8 patients will be used. The outcomes will be recorded by a third party observer in the block room/operating room who might be a nurse or resident or clinical research fellow not directly involved with performing the block. The post procedure outcomes will also be recorded by a clinical research fellow or resident who was not directly involved with performing the block.
No sample size estimation methodology currently exists for the right-censored count data models. We expect less number of attempts in the ultrasound group a 20 % difference between the two groups which we feel is a minimum of a clinically-relevant effect. At the 0.05 level of significance with a power of 0.8, we will require a minimum of 20 patients per group,therefore we plan to recruit 40 patients in total.
The analysis will be conducted by a statistician who will be blinded.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ultrasound-guided spinal anesthesia | Active comparator | Other: ultrasound-guided spinal anesthesiaparticipants will randomly assigned to use ultrasound-guided technique for block placement by Anesthesiologist. |
| standard spinal anesthesia | Placebo comparator | Other: standard spinal anesthesiarandomized participants will be given standard spinal anesthesia insertion technique for block placement by Anesthesiologist |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged 55 or older
- BMI more than 40
- Scoliosis
Key exclusion criteria (1 listed)
- 1 Patients who have undergone previous Spine Surgery
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 |
|---|---|---|
| ultrasound-guided spinal anesthesiaultrasound-guided technique for block placement | Other | ultrasound-guided spinal anesthesia |
| standard spinal anesthesiaAnesthesiologist will use standard technique for placement of spinal block. | Other | standard spinal anesthesia |
Primary outcome
Number of Attempts
Time frame: 10-15 minutes before the surgery
Number of attempts (defined as number of needle reinsertions form the skin and NOT number of redirection of the needle) at the beginning of surgery
3 secondary outcomes
Difficulty of Block Insertion
Time frame: 10-15 minutes before the surgery
Patient Satisfaction
Time frame: after insert the block but before the surgery
Time to Perform Block (Second)
Time frame: as measured in seconds after needle insertion, surgical date
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Hesham Elsharkawy, M.D. principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ultrasound-guided spinal anesthesia and standard spinal anesthesia in people with Patients Aged 55 or Older and BMI More Than 40 kg/m2, run by The Cleveland Clinic 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 3 inclusion and 1 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 26 Jul 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 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. Some participants in this study may receive a placebo. 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 26 Jul 2019). 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?
Number of Attempts (time frame: 10-15 minutes before the 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 26 Jul 2019.