After Cardiac SurgeryNCT05756101
Application of New Restraint Instruments in Safety Management of Patients After Cardiac Surgery
A study testing Research on the application of novel restraint devices in postoperative patient safety management in cardiac surgery in people with After Cardiac Surgery, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
Trial summary
Restraint devices refer to various devices that restrict the activities of the body or a certain part of the body for patients who self-injure or may harm others, so as to maintain the safety of patients and ensure the smooth progress of treatment and care. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- After Cardiac Surgery
- What is being tested?
- Research on the application of novel restraint devices in postoperative patient safety management in cardiac surgery
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2023to 1 Dec 2024
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (1) Elective surgery patients, age ≥ 18 years old; (2) Clear preoperative consciousness and no communication barriers; (3) The surgical method is open-heart surgery under intravenous or inhalation general anesthesia; (4) During ICU treatment, there is endotracheal intubation; (5) Before restraint, there is no joint dysfunction, edema, skin damage, etc. in the site to be restrained, and the peripheral circulation is good; (6) Informed consent and voluntary participation in this study.
Who cannot join
- (1) history of psychiatric illness; (2) Have bleeding tendency or skin diseases; (3) Voluntarily abandon treatment or die halfway.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: General Scientific Research Project of Zhejiang Provincial Department of Education
Restraint devices refer to various devices that restrict the activities of the body or a certain part of the body for patients who self-injure or may harm others, so as to maintain the safety of patients and ensure the smooth progress of treatment and care. The essence of restraint devices is to limit patient movement in order to reduce the risk of unexpected adverse events. With the in-depth implementation of high-quality nursing services, nurses have also paid more and more attention to restraint nursing and developed a variety of restraint tools. Common restraints include bed rails, wrist or ankle restraint straps, restraint vests, shoulder or belt-style restraint straps, mittens, etc. According to the limitations of traditional restraints, Deng Wandi et al. innovatively produced double safety restraint belts, racket gloves and safety vests, and the research results showed that innovative new restraint devices can effectively reduce the psychological pressure of nurses and improve the complications caused by restraint. According to the characteristics of critically ill patients, Xu Yan et al. innovatively produced a three-piece set of safety protection restraint equipment on the basis of the original restraint equipment, which is composed of a safety restraint vest, restraint gloves and knee restraint belt, and the research results show that the new restraint device can effectively reduce the adverse events caused by restraint and improve the satisfaction of family members.
In view of the above problems, our department has developed a new protective restraint device for the protective restraint of postoperative intubated patients, and summarizes the nursing experience to provide clinical reference and theoretical basis for standardizing postoperative patient constraints. The project is now a general scientific research project of Zhejiang Provincial Department of Education, the project name is "Application Research of New Restraint Devices in Postoperative Patient Safety Management in Cardiac Surgery", and the funding source is self-financing.According to the individual characteristics of ICU patients and the needs of patients, a new type of restraint device was innovatively made and the effectiveness and safety of the new restraint device were studied, which provided clinical reference and theoretical basis for standardizing postoperative patient restraint.
Read the detailed description
The study set up control group and experimental group. The control group used sponge restraint belt full name: Medical Care Pad, specifications for: limb restraint belt (Limb Belt Type) . Manufacturer: Shaoxing City, Zhuji City, Zhejiang province, southern Shuda medical supplies factory. The experimental group used an adjustable protective restraint device, including an upper fixing bracket, an upper fixing bracket, a lower fixing bracket, a lower fixing bracket and gloves Air permeability holes are arranged on the fixed supports and air permeability cotton is arranged to increase air permeability and comfort. The elbow joint of the patient was placed on the upper and the lower fixing bracket, and then connected to the upper fixing bracket and the upper fixing bracket through the upper and lower tightening belts, respectively, and the tightness of the upper and lower fixing bracket was adjusted The joint of the upper and lower fixed bracket is the adjustment module one and the adjustment module two, forming a detachable rotational connection in a certain angle range to adjust the patient's elbow joint movement angle; The patient's hand is equipped with a glove with a gripping ball on the palm surface.The national standard for products conforms to GB/T 16886.10-2017/ISO 10993-10:2010, biological evaluation of medical devices, part 10: standards for stimulation and skin sensitization tests.
- Conditions
- After Cardiac Surgery
- Being tested
- Research on the application of novel restraint devices in postoperative patient safety management in cardiac surgery
- Keywords
- Restraints；Postoperative patients；Security management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Research on the application of novel restraint devices in postoperative patient safety management in cardiac surgeryDevice
According to the individual characteristics of ICU patients and the needs of patients, a new type of restraint device was innovatively made and the effectiveness and safety of the new restraint device were studied, which provided clinical reference and theoretical basis for standardizing postoperative patient restraint.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Experimental | Sponge restraint belt, restraint method: adjust the fixed wrist strap according to the diameter of the patient's hand (foot) wrist, and then circle the fixed strap around the wrist strap, one end is pierced through the strap hole without knots, and the two ends of the fixed strap are fixed on both sides of the bed as needed. Receives: Device: Research on the application of novel restraint devices in postoperative patient safety management in cardiac surgery |
| Experimental group | Experimental | A new type of restraint device, which is an adjustable protective restraint device (patent number ZL202020155913.1), including upper fixation bracket I, upper fixation bracket II, lower fixation bracket I, lower fixation bracket II and gloves; The plurality of fixed brackets are provided with breathable holes and breathable cotton is placed to increase air permeability and comfort. Place the patient's elbow joint on top of the lower fixation bracket I and II, and then install and connect the upper fixation bracket I and the upper fixation bracket 2 through the upper and lower tightening belts, and adjust their tightness; The upper and lower fixed bracket connections are adjustment module 1 and adjustment module 2, forming a detachable and rotating connection within a certain angle range to adjust the angle of elbow joint movement of the patient; The patient's hand is made by wearing gloves with a grip ball on the palm surface. Receives: Device: Research on the application of novel restraint devices in postoperative patient safety management in cardiac surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unplanned extubation rate
Unplanned extubation includes extubation without the consent of the healthcare provider; b. The pipeline slips due to various reasons; c. Due to catheter quality problems and catheter blockage, it is necessary to extubate in advance. Unplanned extubation rate = number of unplanned extubation cases in the same period / total number of ICU hospitalizations in the statistical period× 100%.
Measured: This study began with the patient's postoperative use of the protective restraint tool and ended with the removal of the endotracheal intubation to release the protective restraint.No more than a month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2023
- Study start1 Aug 2023 (estimated)
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for After Cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05756101
- Sponsor's protocol ID
- 2022-0916
- Status last verified
- Jan 2023
- First submitted
- 7 Feb 2023
- Last updated
- 6 Mar 2023
- 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 6 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- General Scientific Research Project of Zhejiang Provincial Department of Education
- ClinicalTrials.gov ID
- NCT05756101
- Acronym / sponsor ID
- 2022-0916
- Conditions
- After Cardiac Surgery
- Keywords
- Restraints；Postoperative patients；Security management
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Aug 2023 (estimated)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 6 Mar 2023 (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.
Restraint devices refer to various devices that restrict the activities of the body or a certain part of the body for patients who self-injure or may harm others, so as to maintain the safety of patients and ensure the smooth progress of treatment and care. The essence of restraint devices is to limit patient movement in order to reduce the risk of unexpected adverse events. With the in-depth implementation of high-quality nursing services, nurses have also paid more and more attention to restraint nursing and developed a variety of restraint tools. Common restraints include bed rails, wrist or ankle restraint straps, restraint vests, shoulder or belt-style restraint straps, mittens, etc. According to the limitations of traditional restraints, Deng Wandi et al. innovatively produced double safety restraint belts, racket gloves and safety vests, and the research results showed that innovative new restraint devices can effectively reduce the psychological pressure of nurses and improve the complications caused by restraint. According to the characteristics of critically ill patients, Xu Yan et al. innovatively produced a three-piece set of safety protection restraint equipment on the basis of the original restraint equipment, which is composed of a safety restraint vest, restraint gloves and knee restraint belt, and the research results show that the new restraint device can effectively reduce the adverse events caused by restraint and improve the satisfaction of family members.
In view of the above problems, our department has developed a new protective restraint device for the protective restraint of postoperative intubated patients, and summarizes the nursing experience to provide clinical reference and theoretical basis for standardizing postoperative patient constraints. The project is now a general scientific research project of Zhejiang Provincial Department of Education, the project name is "Application Research of New Restraint Devices in Postoperative Patient Safety Management in Cardiac Surgery", and the funding source is self-financing.According to the individual characteristics of ICU patients and the needs of patients, a new type of restraint device was innovatively made and the effectiveness and safety of the new restraint device were studied, which provided clinical reference and theoretical basis for standardizing postoperative patient restraint.
Detailed description
The study set up control group and experimental group. The control group used sponge restraint belt full name: Medical Care Pad, specifications for: limb restraint belt (Limb Belt Type) . Manufacturer: Shaoxing City, Zhuji City, Zhejiang province, southern Shuda medical supplies factory. The experimental group used an adjustable protective restraint device, including an upper fixing bracket, an upper fixing bracket, a lower fixing bracket, a lower fixing bracket and gloves Air permeability holes are arranged on the fixed supports and air permeability cotton is arranged to increase air permeability and comfort. The elbow joint of the patient was placed on the upper and the lower fixing bracket, and then connected to the upper fixing bracket and the upper fixing bracket through the upper and lower tightening belts, respectively, and the tightness of the upper and lower fixing bracket was adjusted The joint of the upper and lower fixed bracket is the adjustment module one and the adjustment module two, forming a detachable rotational connection in a certain angle range to adjust the patient's elbow joint movement angle; The patient's hand is equipped with a glove with a gripping ball on the palm surface.The national standard for products conforms to GB/T 16886.10-2017/ISO 10993-10:2010, biological evaluation of medical devices, part 10: standards for stimulation and skin sensitization tests.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Experimental | Device: Research on the application of novel restraint devices in postoperative patient safety management in cardiac surgerySponge restraint belt, restraint method: adjust the fixed wrist strap according to the diameter of the patient's hand (foot) wrist, and then circle the fixed strap around the wrist strap, one end is pierced through the strap hole without knots, and the two ends of the fixed strap are fixed on both sides of the bed as needed. |
| Experimental group | Experimental | Device: Research on the application of novel restraint devices in postoperative patient safety management in cardiac surgeryA new type of restraint device, which is an adjustable protective restraint device (patent number ZL202020155913.1), including upper fixation bracket I, upper fixation bracket II, lower fixation bracket I, lower fixation bracket II and gloves; The plurality of fixed brackets are provided with breathable holes and breathable cotton is placed to increase air permeability and comfort. Place the patient's elbow joint on top of the lower fixation bracket I and II, and then install and connect the upper fixation bracket I and the upper fixation bracket 2 through the upper and lower tightening belts, and adjust their tightness; The upper and lower fixed bracket connections are adjustment module 1 and adjustment module 2, forming a detachable and rotating connection within a certain angle range to adjust the angle of elbow joint movement of the patient; The patient's hand is made by wearing gloves with a grip ball on the palm surface. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- (1) Elective surgery patients, age ≥ 18 years old; (2) Clear preoperative consciousness and no communication barriers; (3) The surgical method is open-heart surgery under intravenous or inhalation general anesthesia; (4) During ICU treatment, there is endotracheal intubation; (5) Before restraint, there is no joint dysfunction, edema, skin damage, etc. in the site to be restrained, and the peripheral circulation is good; (6) Informed consent and voluntary participation in this study.
Key exclusion criteria (1 listed)
- (1) history of psychiatric illness; (2) Have bleeding tendency or skin diseases; (3) Voluntarily abandon treatment or die halfway.
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 |
|---|---|---|
| Research on the application of novel restraint devices in postoperative patient safety management in cardiac surgeryAccording to the individual characteristics of ICU patients and the needs of patients, a new type of restraint device was innovatively made and the effectiveness and safety of the new restraint device were studied, which provided clinical reference and theoretical basis for standardizing postoperative patient restraint. | Device | Control group, Experimental group |
Primary outcome
Unplanned extubation rate
Time frame: This study began with the patient's postoperative use of the protective restraint tool and ended with the removal of the endotracheal intubation to release the protective restraint.No more than a month.
Unplanned extubation includes extubation without the consent of the healthcare provider; b. The pipeline slips due to various reasons; c. Due to catheter quality problems and catheter blockage, it is necessary to extubate in advance. Unplanned extubation rate = number of unplanned extubation cases in the same period / total number of ICU hospitalizations in the statistical period× 100%.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2023.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Research on the application of novel restraint devices in postoperative patient safety management in cardiac surgery in people with After Cardiac Surgery, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
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 1 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 6 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Lin Huaxiang, Bachelor of Medicine (15167180315, chunhai7138@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unplanned extubation rate (time frame: This study began with the patient's postoperative use of the protective restraint tool and ended with the removal of the endotracheal intubation to release the protective restraint.No more than a month.). 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 6 Mar 2023.