General Scientific Research Project of Zhejiang Provincial Department of Education
Phase: NA
Conditions: After Cardiac Surgery
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

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Protective constraints, also known as physical constraints, the US Bureau of
Health care (HCFA) defines it as "with any physical or mechanical equipment,
materials or tools attached to or adjacent to the patient's body, so that
patients can not easily remove it, in order to limit the free movement of
patients or the normal access to their own body". In order to avoid risks such as
unplanned extubation and ensure patient safety, the majority of ICU caregivers
believe that protective constraint is one of the important measures for the
safety management of ICU patients. Therefore, protective constraint has become a
common nursing problem in intensive care units at home and abroad. At the same
time, with the deepening of humanistic concepts, protective constraints are also
getting more and more attention. In 2003, the American Association of Critical
Care Medicine developed the clinical implementation guidelines for the technical
evaluation of restraint necessity levels, in order to ensure the physical and
mental health of ICU patients. In 2004, the British Association of Critical Care
Nurses developed practical guidance for adult protective constraints in intensive
care units, stating that protective constraints are optimal patient care and
should not replace inadequate human resources as one of the routine care measures
in the ICU. In 2016, the Nursing Center of the National Institute of Health and
Family Planning Hospital Management in China included the "physical constraint
rate of hospitalized patients" in the Practical Manual of Nursing Sensitive
Quality Indicators, aiming to reduce the overuse of protective constraints in ICU
patients.
Constraint equipment refers to the self-injury, may hurt others and patients
to limit the activities of the body or a part of the body, in order to achieve
the maintenance of the safety of patients, to ensure the smooth treatment,
nursing of all kinds of appliances. The essence of the constraint appliance is to
limit patient activity to reduce the risk of unexpected adverse events. With the
in-depth implementation of quality nursing services, nurses are also paying more

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and more attention to restraint nursing, and developed a variety of restraint
appliances. Common restraint appliances include bed bars, wrist or ankle
restraint belt, restraint vest, shoulder belt or belt type restraint belt,
mittens, etc. According to the limitations of traditional restraint appliances,
Deng Wandi et al. innovatively made double insurance restraint belt, racket
gloves and safety vest. The research results showed that the innovative new
restraint appliances can effectively reduce the psychological pressure of nurses
and improve the complications caused by restraint. Xu Yan according to the
characteristics of severe patients on the basis of the original constraint
appliance innovation made safety protection three-piece set of constraint
appliance, the appliance consists of safety constraints vest, gloves and knee
constraints, the results show that the new constraint appliance can effectively
reduce constraints of adverse events, improve family satisfaction.
In view of the above problems, the department developed a new protective
restraint device, which is used for the protective restraint of postoperative
intubation patients, and summarized nursing experience to provide clinical
reference and theoretical basis for standardizing postoperative patient restraint.
This project is now a general scientific research project of Zhejiang Provincial
Department of Education. The project name is "Research on the Application of New
restraint appliance in the Safety Management of Patients after cardiac surgery",
and the funding source is
Self-raised.
According to the individual characteristics of ICU patients, combined with the
needs of patients, the innovative production of a new restraint appliance and study
the effectiveness and safety of the new restraint appliance, to provide clinical
reference and theoretical basis for the standardization of postoperative patient
restraint.

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3.1 This study used random number table to divide the subjects into control and
experimental groups.
3.2 The research period of the whole project starts from the date of ethical passage
and ends in 2024.
3.3 Inclusion criteria: ①elective surgery patients, age 18; ②preoperative
awareness and no communication impairment; ③open heart surgery under intravenous
or inhalation general anesthesia; ④ICU During the treatment, endotracheal
intubation existed; before ⑤restraint, there was no joint dysfunction, edema, skin
damage, etc. at the proposed restraint site, and the peripheral circulation was good;
⑥gave informed consent to participate in this study. Exclusion criteria: ①had a
history of mental illness; ②had bleeding tendency or skin disease; voluntary
abandonment of treatment or death in ③.
3.4 Sampling strategy and grouping: This study used the convenient sampling
method to select the research subjects, and then the included subjects were
randomly divided into control group and experimental group according to the coin
throwing method. The control group used the restraint appliance as the sponge
restraint belt, and the experimental group used the restraint appliance as the
new restraint appliance.
3.5 Interventions:
3.5.1 Control group: sponge restraint band, restraint method: adjust the fixed
wrist band according to the wrist diameter of the patient's hand (foot), and then
circle the fixed band around the wristband, one end of the puncture hole without
tying, and the two ends of the fixed band are fixed on both sides of the bed as
needed.
3.5.2 Experimental group: new restraint appliance, which is an adjustable
protective restraint device (patent No. ZL202020155913.1), including upper
bracket 1, upper bracket 2, lower bracket 2 and gloves; the multiple fixed
supports are provided with air holes and breathable cotton to increase air
permeability and comfort. Place the patient's elbow with the lower fixed bracket
one and two, and then connect the upper fixed bracket one and the upper and lower
fixed bracket two, and adjust the tightness, and the other to form a removable
and rotating connection in a certain angle range to adjust the movement angle of
the patient's elbow joint; set the patient's hand with the palm of the glove. The
device was commissioned by Anshan Deyi Da Medical Device Technology Co., LTD.

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(Business license registration number: 912103003966197061, class I medical device
production record No.: Liaoan Food and Drug Device Production Preparation
20200011).
3.6, Outcome measures
.13.6 Outcome decision time
This study starts with the use of the protective restraint tool after
surgery until the removal of the endotracheal tube..23.6 Main outcome
measures
I Adverse event rate of nursing care:
Unplanned extubation rate: unplanned extubation includes a self-extubation
without the consent of medical staff; b. Pipeline slip caused by various reasons;
c. Extubation needs to be performed in advance due to catheter quality problems
and catheter blockage. Unplanned extubation rate = number of unplanned extubation
cases in the same period / total number of ICU inpatients in the statistical
period 100%.

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.73 Data collection
Data were collected by on-site assessment and medical record review. General
demographic data including age, gender, education, marital status, occupation,
smoking, alcohol consumption, health insurance type, surgical mode, admission
diagnosis, history of underlying diseases, were collected by the investigator by
medical record review. The incidence of nursing adverse events, duration of
restraint period, cumulative dose of sedation used, length of ICU stay, and total
cost of ICU treatment were collected by the investigator through the electronic
medical system and integrated nursing information platform before pre-transfer to
the ICU. Anxiety, depression and comfort were assessed by the responsible nurse
within 24h after the patient woke from anesthesia and on the day the patient was pre-
transferred out of the ICU.
.83 Quality control
.8.13 The hospital has established a unified and standardized restraint process,
and will regularly regular restraint and skin care training for nurses.
.23.8 Each class has a responsible leader, who will check the skin assessment and
the rigor of nursing records, and ensure the quality of nursing records.
3.8.3 Double verification during data collection and entry.
.93 Statistical analysis
.0 Statistical analysis by SPSS 25 software, frequency and percentage for count
data, chi-square test or Fisher test for between-group comparison, mean ± standard
deviation for normal distribution data, t-test for groups, non-normal distribution
data, and non-parametric test for between-group comparison. A P <0.05 was considered
as a statistically significant difference.
4.1 The subjects analyzed in this study are all vulnerable groups after cardiac
surgery. For subjects, the data obtained in this study are only used for research,
and they are not publicly available outside the scope permitted by relevant laws
and / or regulations.
The test group and the control group were selected separately 5 For example, patients.

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All records concerning the identity of the subject are kept confidential
and are not publicly available beyond the extent permitted by the relevant laws
and / or regulations.
For the patients who meet the inclusion criteria, the physician in charge
will inform the patients and their families of the purpose of the protective
restraint and the related risks that may occur.
Take corresponding measures in time, and record them in the case report form.

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The control group used the sponge restraint belt full name: medical care mat,
the specification and model are: limb restraint belt (limb belt type).
Manufacturer: Zhejiang Province, Zhuji City, Shaoxing City, Chengnan Shuda
medical supplies factory.
The experimental group used an adjustable protective restraint device,
including upper bracket 1, upper bracket 2, lower bracket 1, lower bracket 2 and
gloves; air holes and breathable cotton to increase air permeability and comfort.
Place the patient's elbow with the lower fixed bracket one and two, and then
connect the upper fixed bracket one and the upper and lower fixed bracket two and
adjust the tightness, and the other to form a removable and rotating connection
in a certain angle range to adjust the movement angle of the patient's elbow
joint; set the patient's hand with the palm of the glove.
The national standards of the product comply with GB / T 16886.10-2017 /
ISO 10993-10:2010 criteria for biological evaluation of medical devices-Part 10:
Test for irritation and skin sensitization. Product-related qualifications and
physical objects are shown in the following figure.

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