Compartment Syndrome of ForearmNCT05605990
Clinical Application and Validation of Innovative Tourniquet
A study testing Innovative tourniquet (Acusense Nonpneumatic tourniquet) in people with Compartment Syndrome of Forearm, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial summary
Background: Tourniquets are the basic equipment for nurses to perform blood draws, and venous indwelling needles for congestion, or for hemostasis. Therefore, forgetting to remove the tourniquet is a common problem that leads to blood circulation being blocked, and even severe tissue necrosis occurred. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Compartment Syndrome of Forearm
- What is being tested?
- Innovative tourniquet (Acusense Nonpneumatic tourniquet)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Dec 2022to 31 Dec 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Inclusion Criteria: Nurse group: We included nurses who have working experience of more than 3 months, and are willing to use an innovative tourniquet.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan
Tainan, 722
About this study
Background: Tourniquets are the basic equipment for nurses to perform blood draws, and venous indwelling needles for congestion, or for hemostasis. Therefore, forgetting to remove the tourniquet is a common problem that leads to blood circulation being blocked, and even severe tissue necrosis occurred.
Purpose: The study aimed to evaluate whether this innovative tourniquet could prevent forgetting to remove the tourniquet, and improve the satisfaction of care.
Read more
Research design: This clinical research trial was a quasi-experimental study designed for a single group with pre-and post-test. We will recruit 160 nurses in high-risk units of the hospital. The delay in removing the tourniquet as our study outcome is defined as the removing time delay of one minute.
Expected results: The research results will provide some evidence of the efficacy of intelligent tourniquets.
- Conditions
- Compartment Syndrome of Forearm
- Being tested
- Innovative tourniquet (Acusense Nonpneumatic tourniquet)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Innovative tourniquet (Acusense Nonpneumatic tourniquet)Device
To use this innovative tourniquet before collecting blood samples, and setting IV catheter. We also use this innovative tourniquet to occlude the flow of blood.
| Study group | Role | What they receive |
|---|---|---|
| Nurse group | Experimental | Using an innovative tourniquet (Acusense Nonpneumatic tourniquet) for the standard of care Receives: Device: Innovative tourniquet (Acusense Nonpneumatic tourniquet) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preventing the forgetting to remove the tourniquet
Forgetting to remove the tourniquet is defined as the optimal removing time to delay of one minute.
Measured: A three months period
Enhancing nurses' satisfaction
The Likert Scale asks how much a person agrees or disagrees with a particular statement or question. It is usually made up of a 5-point rating scale ranging from 1 and 5 with 10-item.
Measured: A three months period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2022
- Study start1 Dec 2022
- Primary completion30 Jun 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Compartment Syndrome of ForearmStudies of the same condition, open and under way.
- More trials run by National Cheng-Kung University HospitalThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- We will recruit 160 nurses in high-risk units of the hospital.
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chou-Ching Lin, National Cheng-Kung University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05605990
- Sponsor's protocol ID
- IRB No.A-BR-111-011
- Status last verified
- Apr 2024
- First submitted
- 25 Oct 2022
- Last updated
- 9 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Gorski LA, Hadaway L, Hagle ME, Broadhurst D, Clare S, Kleidon T, Meyer BM, Nickel B, Rowley S, Sharpe E, Alexander M. Infusion Therapy Standards of Practice, 8th Edition. J Infus Nurs. 2021 Jan-Feb 01;44(1S Suppl 1):S1-S224. doi: 10.1097/NAN.0000000000000396. No abstract available.
PubMed 33394637Lee C, Porter KM, Hodgetts TJ. Tourniquet use in the civilian prehospital setting. Emerg Med J. 2007 Aug;24(8):584-7. doi: 10.1136/emj.2007.046359.
PubMed 17652690Pinkerton C. New technology enhances expertise of vascular access team. Can Nurse. 2009 Feb;105(2):21-2. No abstract available.
PubMed 19263937Duignan KM, Lamb LC, DiFiori MM, Quinlavin J, Feeney JM. Tourniquet use in the prehospital setting: Are they being used appropriately? Am J Disaster Med. 2018;13(1):37-43. doi: 10.5055/ajdm.2018.0286.
PubMed 29799611
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Application and Validation of Innovative Tourniquet
- ClinicalTrials.gov ID
- NCT05605990
- Acronym / sponsor ID
- IRB No.A-BR-111-011
- Conditions
- Compartment Syndrome of Forearm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 4 Nov 2022 (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.
Background: Tourniquets are the basic equipment for nurses to perform blood draws, and venous indwelling needles for congestion, or for hemostasis. Therefore, forgetting to remove the tourniquet is a common problem that leads to blood circulation being blocked, and even severe tissue necrosis occurred.
Purpose: The study aimed to evaluate whether this innovative tourniquet could prevent forgetting to remove the tourniquet, and improve the satisfaction of care.
Research design: This clinical research trial was a quasi-experimental study designed for a single group with pre-and post-test. We will recruit 160 nurses in high-risk units of the hospital. The delay in removing the tourniquet as our study outcome is defined as the removing time delay of one minute.
Expected results: The research results will provide some evidence of the efficacy of intelligent tourniquets.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- We will recruit 160 nurses in high-risk units of the hospital.
| Arm | Type | Receives |
|---|---|---|
| Nurse group | Experimental | Device: Innovative tourniquet (Acusense Nonpneumatic tourniquet)Using an innovative tourniquet (Acusense Nonpneumatic tourniquet) for the standard of care |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| Innovative tourniquet (Acusense Nonpneumatic tourniquet)To use this innovative tourniquet before collecting blood samples, and setting IV catheter. We also use this innovative tourniquet to occlude the flow of blood. | Device | Nurse group |
Primary outcome
Preventing the forgetting to remove the tourniquet
Time frame: A three months period
Forgetting to remove the tourniquet is defined as the optimal removing time to delay of one minute.
Enhancing nurses' satisfaction
Time frame: A three months period
The Likert Scale asks how much a person agrees or disagrees with a particular statement or question. It is usually made up of a 5-point rating scale ranging from 1 and 5 with 10-item.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2024.
- Results publication: PubMed 33394637Gorski LA, Hadaway L, Hagle ME, Broadhurst D, Clare S, Kleidon T, Meyer BM, Nickel B, Rowley S, Sharpe E, Alexander M. Infusion Therapy Standards of Practice, 8th Edition. J Infus Nurs. 2021 Jan-Feb 01;44(1S Suppl 1):S1-S224. doi: 10.1097/NAN.0000000000000396. No abstract available.
- Results publication: PubMed 17652690Lee C, Porter KM, Hodgetts TJ. Tourniquet use in the civilian prehospital setting. Emerg Med J. 2007 Aug;24(8):584-7. doi: 10.1136/emj.2007.046359.
- Results publication: PubMed 19263937Pinkerton C. New technology enhances expertise of vascular access team. Can Nurse. 2009 Feb;105(2):21-2. No abstract available.
- Results publication: PubMed 29799611Duignan KM, Lamb LC, DiFiori MM, Quinlavin J, Feeney JM. Tourniquet use in the prehospital setting: Are they being used appropriately? Am J Disaster Med. 2018;13(1):37-43. doi: 10.5055/ajdm.2018.0286.
- Individual participant dataSharing planned: Undecided
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 record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Innovative tourniquet (Acusense Nonpneumatic tourniquet) in people with Compartment Syndrome of Forearm, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2024. 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 Taiwan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Preventing the forgetting to remove the tourniquet (time frame: A three months period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05605990, which also lists 4 linked publications.
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 9 Apr 2024.