1.1 General Data
1.1.1 Study subjects:
132 septic patients admitted to the Department of Critical Care Medicine of our hospital from January 1 to December 31, 2018 were selected as the control group; 138 septic patients admitted from January 1 to December 31, 2019 were selected as the observation group. This study was conducted in accordance with the Declaration of Helsinki and approved by the ethics committee of Hebei General Hospital.
1.1.2 Inclusion criteria:
Meeting the diagnostic criteria of the Chinese Guidelines for the Treatment of Severe Sepsis/Septic Shock (2014) by the Chinese Society of Intensive Care Medicine Branch [3], and admission to the ICU to confirm the diagnosis of sepsis with a duration of stay longer than six hours.
1.1.3 Exclusion criteria:
Termination of treatment, discharge or death within six hours after admission.
1.1.4 Ethics:
The study was approved by the hospital’s medical ethics committee; approval number (2020), ethical review No. 108. The Informed Consent Form was signed with the patient's family and the subject could voluntarily terminate their participation in the study at any time and would not be prevented from receiving further treatment.
1.2 Study methods:
A prospective cohort study was used.
1.2.1 Control group:
As required by the Chinese Guidelines for the Treatment of Severe Sepsis/Septic Shock and the Professional Quality Control Index for Critical Care Medicine (2015), the physician diagnosed sepsis and notified the nurse. The nurse immediately measured temperature, blood pressure, central venous pressure (CVP), and central venous oxygen saturation (ScvO2) and inserted an indwelling urinary catheter. The doctor gave medical orders for antimicrobial infusion, rehydration, application of antihypertensive drugs, collection of blood culture, blood gas analysis, blood routine, calcitonin, and other specimens. The nurse immediately carried out these orders and closely observed the improvement of blood pressure, urine volume, skin endings, etc. The doctors and nurses reminded each other to complete the above treatment measures within six hours.
1.2.2 The sepsis treatment team
for observation group A was established in the department and all medical and nursing staff under the leadership of medical and nursing team leaders applied PDCA cycle management to the problems in the sepsis bundles.
1.2.2.1 Plan (P):
132 cases of sepsis from January to December 2018 were retrospectively investigated. The problems identified in the process of cluster therapy were that antibiotics could not be given in time, the retention rate of blood culture before the application of antibiotics was low, the measurement of ScvO2 and CVP was delayed or not measured, the measurement of lactic acid was delayed, and the volume of fluid and dosage did not meet the guideline requirements (see Table 1). The main reasons for poor adherence were analyzed as busy medical and nursing staff, insufficient knowledge of guidelines, poor awareness of ScvO2 and CVP measurement, lack of antimicrobial stockpiles in the department, and a delay in medical record transfer and order creation resulting in a medication time greater than one hour. The causes of poor adherence were plotted into a fishbone diagram of cause analysis (see Fig. 1). Group members used evaluation methods and other means to identify the main causes and highlighted them with red circles on the fishbone diagram.
1.2.2.2 Development (D):
From January 2019, corresponding improvement strategies were formulated for different causes and medical staff continued to implement the cluster therapy strategies for sepsis on the basis of improvement. Specific improvement measures are shown in Table 2.
1.2.2.3 Check (C):
After the implementation of improvement measures, the completion rates of the sepsis bundles for one hour, three hours, and six hours were calculated, respectively.
1.2.2.4 Assessment (A):
Standardize the process of sepsis cluster treatment (see Table 3) and continuously evaluate future implementation processes to ensure the scientificity and effectiveness of the measures.
1.3 An evaluation index
was used to compare the completion rates for one hour, three hours, and six hours for sepsis bundles in the observation and control groups.
1.4 Statistical methods:
The data used in this study were analyzed using SPSS 18.0. The comparison of the count data was performed by the χ2 test and the mean ± standard deviation (± s) was used for statistical description. The t-test and ANOVA (with necessary correction in case of variance) were used for the comparison of differences between groups, F-values were calculated, and a P-value under 0.05 was considered statistically significant.
Table 1
The compliance of 132 sepsis patients with 1 h, 3 h and 6 h of cluster bundle (n = 132)
Indicators
|
1 h cases (n) /compliance rate (%)
|
3 h cases (n) /compliance rate (%)
|
6 h cases (n) /compliance rate (%)
|
Measurement of lactate concentration
|
119/(90.1)
|
130/(98.5)
|
131/(99.2)
|
Blood culture before antibiotic therapy
|
87/(65.9)
|
92/(69.7)
|
103/(78.0)
|
Administer broad-spectrum antimicrobial drugs
|
91/(68.9)
|
95/(72.0)
|
105/(79.5)
|
Give 30 ml/kg crystalloid for target resuscitation for hypotension or lactate ≥ 4 mmol/L
|
93/(70.5)
|
96/(72.7)
|
102/(77.3)
|
Administering antihypertensive drugs
|
132/(100)
|
132/(100)
|
132/(100)
|
Measure CVP
|
90/(68.2)
|
102/(77.3)
|
110/(83.3)
|
Measure ScvO2
|
87/(65.9)
|
93/(70.5)
|
108/(81.8)
|
Repeat lactate level measurement
|
92/(69.7)
|
99/(75.0)
|
113/(85.6)
|
Table 2
Countermeasures for poor compliance of sepsis bundle
Problems
|
Countermeasures
|
Poor awareness of doctors in ScvO2 measurement
|
1. Strengthen the awareness of doctors and nurses on the importance and necessity of sepsis centralized treatment.
2. Formulate the process of sepsis centralized treatment and emphasize the joint compliance of doctors and nurses.
3. Dedicated personnel for supervision and quality control.
4. Develop a reward and punishment program.
|
Poor awareness of nurses in active CVP measurement
|
Antimicrobials cannot be retrieved within 1 h
|
1. Apply to the pharmacy department to reserve commonly used antimicrobials as base drugs.
2. Communicate with the pharmacy department to be able to temporarily borrow medication when the department's reserve is insufficient or cannot meet treatment needs, and then return the borrowed medication after the medical records are transferred and the medical orders are promptly made up.
3. When the preparation is insufficient, the nursing team leader is responsible for having the antimicrobial agent ready at the first time after the diagnosis of sepsis is confirmed.
4. For antimicrobials requiring skin tests, the deputy team leader on duty is responsible for the configuration of the skin test solution, implementation of the skin test and observation of the results.
|
Lack of process system
|
1. Develop a departmental management system for improving compliance with sepsis bundle.
2. Formulate a flow chart of sepsis bundle.
3. Dedicated person is responsible for supervision and quality control of the implementation of the established system and process.
4. Set up a sepsis treatment team including doctors and nurses, and have team members on duty in every shift to ensure the timeliness and effectiveness of sepsis bundle.
|
Table 3
Time
|
Admission to ICU 1 h
|
Admission to ICU 3 h
|
Admission to ICU 6 h
|
Indicators to be completed
|
□ Assess the condition and execute emergency medical orders, such as cooperate with doctors for tracheal intubation
□ Establish dual fluid lines with ≤ 22G indwelling needle, and establish central venous access with the physician
□ perform invasive blood pressure monitoring by puncturing artery
□ collect various specimens, especially blood gas, and measure blood lactate concentration
□ Perform blood culture before applying antimicrobial drugs
□ give broad-spectrum antibacterial drug treatment
□ Resuscitate with 30 ml/kg crystalloid solution as prescribed for hypotension or lactate ≥ 4 mmol/L
|
□ Continue the items not completed within 1 h, especially
○Measure blood lactate concentration
○Blood culture before applying antimicrobial drug treatment
○Treat with broad-spectrum antibacterial drugs
○Give 30 ml/kg crystalloid for target resuscitation for hypotension or lactate ≥ 4 mmol/L
□ Perform other monitoring, treatment and care
|
□Continue the program within 3 h
□Give blood pressure raising drugs
□Measure CVP
□ Measure ScvO2
□ Repeat measurement of blood lactate level
|