AnesthesiaEPAPHUSNCT03429010
Efficacy of Perioperative Anesthesia Care Bundle on Prognosis in Elderly Undergoing Hip Fracture Surgery
A study testing New "guideline" anesthesia strategy team in people with Anesthesia and Hip Fracture Surgery, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.
Trial summary
This study is going to research the hypothesis that to strengthen the comprehensive treatment of perioperative anesthesia is possible to improve the prognosis of patients with hip fracture and reduce mortality. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Anesthesia, Hip Fracture Surgery, Nursing
- What is being tested?
- New "guideline" anesthesia strategy team
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2018to 31 Dec 2020
- 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients ≥ 75 years old;
- Patients with hip fracture purely and surgical treatment is scheduled.
Who cannot join
- Surgical treatment has been performed after entering hospital;
- Multiple trauma: multiple fractures; chest, abdomen, pelvis and sacral trauma; severe head injury, etc.
- Refuse to sign informed consent;
- Investigator thinks he/she is inappropriate to carry out this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 32500
TING LI, 13587876896, feclinicalresearch@163.com
About this study
Official title: Efficacy of Perioperative Anesthesia Care Bundle on Prognosis in Elderly Undergoing Hip Fracture Surgery: a Single-center Randomized Controlled Trial
This study is going to research the hypothesis that to strengthen the comprehensive treatment of perioperative anesthesia is possible to improve the prognosis of patients with hip fracture and reduce mortality. This is a randomized controlled pilot study aimed to elderly patients with hip fracture on one side and needing surgical treatment.
Read the detailed description
To evaluate the efficacy of perioperative anesthesia care bundle on prognosis in elderly undergoing hip fracture surgery; to assess the levels of compliance that current anesthesia management strategy of our hospital against the new "guidelines"; and to analyze the defects in the current anesthesia management strategy and collect data for further multi-center research, this single-center randomized controlled trial was conducted. The central stochastic system was adopted to determined the stratification factors by age, POSSUM score, whether there was tracheal intubation or laryngeal mask auxiliary ventilation. Therefore, there are two groups including the new version of "guidelines" anesthesia strategy group and existing anesthesia strategy group at a ratio of 1:1. The mortality is the primary indicator will be collected in 1,6,12 months after surgery. And VAS score, MMSE, length of hospital stay and so forth, which would be collected as the secondary indicators.
- Conditions
- Anesthesia, Hip Fracture Surgery, Nursing
- Being tested
- New "guideline" anesthesia strategy team
- Keywords
- Anesthesia, Hip Fracture
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New "guideline" anesthesia strategy teamProcedure or surgery
New "guideline" anesthesia strategy team
| Study group | Role | What they receive |
|---|---|---|
| New "guideline" | Experimental | New "guideline" anesthesia strategy team (Group A) Receives: Procedure: New "guideline" anesthesia strategy team |
| Current strategy | No intervention | Current anesthesia strategy team (Group B) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Mortality in 6 months of postoperative
Measured: 6 months after surgery
Secondary outcomes (9)
Visual Analogue Score(VAS)
The intensity of postoperative pain using Visual Analogue Score(VAS), has a total score of 10 range from 0 to 10. Do higher values represent a severer pain.
Measured: within two days after surgery
Complications
The incidence of postoperative complications
Measured: post-operation to discharge, an average of 2 weeks
Death rate
Mortality for postoperative of 30 days and 1 year
Measured: Within 30 days and 1 year after surgery
Survival time
Observed length of time after surgery to death within one year
Measured: up to one year after surgery
Compliance score
The level of compliance of new "guideline"(from the ratio of (score:total score)), the ratio from 0% to 100%
Measured: Duration of hospital stay, an average of 2 weeks
Hospital stay
Length of time stay in hospital
Measured: Up to discharge,an average of 2 weeks
Cost
Total cost in hospital and expenditure for anesthesia
Measured: Length of hospital stay,an average of 2 weeks
MMSE
Cognitive function with Mini-Mental State Examination (MMSE)
Measured: Two days after surgery
Satisfaction score
Overall satisfaction of patients, with a range of 0 to 5 points. 0 point represents not satisfied at all and 5 points mean greatly satisfied.
Measured: Two weeks before discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2018
- Study start1 Jul 2018
- Primary completion1 Nov 2019 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Wenzhou Medical 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03429010
- Sponsor's protocol ID
- SAHoWMU-CR2017-03-110
- Acronym
- EPAPHUS
- Status last verified
- Sep 2019
- First submitted
- 18 Jan 2018
- Last updated
- 25 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Perioperative Anesthesia Care Bundle on Prognosis in Elderly Undergoing Hip Fracture Surgery: a Single-center Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03429010
- Acronym / sponsor ID
- EPAPHUS / SAHoWMU-CR2017-03-110
- Conditions
- Anesthesia, Hip Fracture Surgery, Nursing
- Keywords
- Anesthesia, Hip Fracture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 1 Nov 2019 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 12 Feb 2018 (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.
This study is going to research the hypothesis that to strengthen the comprehensive treatment of perioperative anesthesia is possible to improve the prognosis of patients with hip fracture and reduce mortality. This is a randomized controlled pilot study aimed to elderly patients with hip fracture on one side and needing surgical treatment.
Detailed description
To evaluate the efficacy of perioperative anesthesia care bundle on prognosis in elderly undergoing hip fracture surgery; to assess the levels of compliance that current anesthesia management strategy of our hospital against the new "guidelines"; and to analyze the defects in the current anesthesia management strategy and collect data for further multi-center research, this single-center randomized controlled trial was conducted. The central stochastic system was adopted to determined the stratification factors by age, POSSUM score, whether there was tracheal intubation or laryngeal mask auxiliary ventilation. Therefore, there are two groups including the new version of "guidelines" anesthesia strategy group and existing anesthesia strategy group at a ratio of 1:1. The mortality is the primary indicator will be collected in 1,6,12 months after surgery. And VAS score, MMSE, length of hospital stay and so forth, which would be collected as the secondary indicators.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| New "guideline" | Experimental | Procedure: New "guideline" anesthesia strategy teamNew "guideline" anesthesia strategy team (Group A) |
| Current strategy | No intervention | –Current anesthesia strategy team (Group B) |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Patients ≥ 75 years old;
- Patients with hip fracture purely and surgical treatment is scheduled.
Key exclusion criteria (4 listed)
- Surgical treatment has been performed after entering hospital;
- Multiple trauma: multiple fractures; chest, abdomen, pelvis and sacral trauma; severe head injury, etc.
- Refuse to sign informed consent;
- Investigator thinks he/she is inappropriate to carry out this study.
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 |
|---|---|---|
| New "guideline" anesthesia strategy teamNew "guideline" anesthesia strategy team | Procedure or surgery | New "guideline" |
Primary outcome
Mortality
Time frame: 6 months after surgery
Mortality in 6 months of postoperative
9 secondary outcomes
Visual Analogue Score(VAS)
Time frame: within two days after surgery
Complications
Time frame: post-operation to discharge, an average of 2 weeks
Death rate
Time frame: Within 30 days and 1 year after surgery
Survival time
Time frame: up to one year after surgery
Compliance score
Time frame: Duration of hospital stay, an average of 2 weeks
Hospital stay
Time frame: Up to discharge,an average of 2 weeks
Cost
Time frame: Length of hospital stay,an average of 2 weeks
MMSE
Time frame: Two days after surgery
Satisfaction score
Time frame: Two weeks before discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2019.
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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.
The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
Wenzhou, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing New "guideline" anesthesia strategy team in people with Anesthesia and Hip Fracture Surgery, run by Second Affiliated Hospital of Wenzhou Medical 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 4 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 Sep 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 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. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 6 months after 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 25 Sep 2019.