Epidural AnesthesiaNCT02537665
Heating Precondition of Epidural Catheter Decrease the Incidence of Injury to Blood Vessel During Epidural Catheter Placement
A study testing heating precondition in people with Epidural Anesthesia, run by Fudan University at 1 site in China.
Trial summary
To explore the effect of heating precondition of epidural catheter on the incidence of injury to blood vessel during epidural catheter placement. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Epidural Anesthesia
- What is being tested?
- heating precondition
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Jun 2015to Sep 2015
- 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Elective cesarean delivery
- Epidural anesthesia.
Who cannot join
- blood coagulation disorders
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University
Shanghai, Shanghai Municipality, 200090
Guiqi Mi Geng, PhD, 86 21 33189900 ext. 6868, mzgengguiqi@163.com
About this study
To explore the effect of heating precondition of epidural catheter on the incidence of injury to blood vessel during epidural catheter placement.
- Conditions
- Epidural Anesthesia
- Being tested
- heating precondition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
heating preconditionOther
| Study group | Role | What they receive |
|---|---|---|
| incidence of bleeding | Other | the effect of the epidural catheter filled with heated or normal saline before inserting into epidural on the incidence of bleeding. Receives: Other: heating precondition |
| inserting time of catheter | Placebo comparator | record the time from beginning of catheter inserting to completing the placement of the catheter. Receives: Other: heating precondition |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of injury to blood vessel during epidural catheter placement
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2015 (estimated)
- Study startJun 2015
- Primary completionSep 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epidural AnesthesiaStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Geng guiqi, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02537665
- Sponsor's protocol ID
- 19990807
- Status last verified
- Aug 2015
- First submitted
- 27 Aug 2015
- Last updated
- 1 Sep 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heating Precondition of Epidural Catheter Decrease the Incidence of Injury to Blood Vessel During Epidural Catheter Placement
- ClinicalTrials.gov ID
- NCT02537665
- Acronym / sponsor ID
- 19990807
- Conditions
- Epidural Anesthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Sep 2015 (estimated)
- First posted
- 1 Sep 2015 (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.
To explore the effect of heating precondition of epidural catheter on the incidence of injury to blood vessel during epidural catheter placement.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| incidence of bleeding | Other | Other: heating preconditionthe effect of the epidural catheter filled with heated or normal saline before inserting into epidural on the incidence of bleeding. |
| inserting time of catheter | Placebo comparator | Other: heating preconditionrecord the time from beginning of catheter inserting to completing the placement of the catheter. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Elective cesarean delivery
- Epidural anesthesia.
Key exclusion criteria (1 listed)
- blood coagulation disorders
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 |
|---|---|---|
| heating precondition | Other | incidence of bleeding, inserting time of catheter |
Primary outcome
the incidence of injury to blood vessel during epidural catheter placement
Time frame: 5 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2015.
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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 heating precondition in people with Epidural Anesthesia, run by Fudan University 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 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: status not confirmed, as of the sponsor's last update on 1 Sep 2015. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guiqi Geng, PhD (86 21 33189900, mzgengguiqi@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the incidence of injury to blood vessel during epidural catheter placement (time frame: 5 minutes). 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 1 Sep 2015.