Gentamicin condensation pot method

Abstract

The invention relates to the field of medical treatment, and discloses a gentamicin condensation pot method which at least comprises the following steps: S1, selecting and grouping patients; s2, a control experiment process; s3, monitoring and recording; and S4, analyzing and evaluating. According to the method, gentamicin is added into the condensing kettle of the breathing machine, the continuous sterilization effect of antibiotics in condensed water is achieved, the antibiotics can act on bacteria in a pipeline of the breathing machine for a long time, and therefore the occurrence rate of VAP is effectively reduced, clinical test results can prove that the method can remarkably shorten the mechanical ventilation time and the hospitalization time of ICU patients, and the method is suitable for popularization and application. The method has the advantages that the use rate of antibiotics is reduced, the hospitalization cost of ICU is reduced, the prognosis of patients with mechanical ventilation is improved, and an effective solution is provided for preventing VAP.

Description

Technical Field

[0001] The invention relates to the technical field of medical technology, in particular to a gentamicin condensation pot method. Background Art

[0002] Ventilator-associated pneumonia (VAP) is a common and serious complication in the intensive care unit (ICU), with an incidence rate ranging from 9.7% to 48.4% and a mortality rate as high as 21.2% to 43.2%. This not only poses a huge threat to the life and health of patients, but also increases the medical burden and resource consumption. Traditional prevention strategies mainly rely on empirical treatment and enhanced nursing measures, but these methods lack precise prevention and control of specific pathogens.

[0003] In recent years, the research on ventilator condensate (VAC) has gradually deepened, and it has been found that it is closely related to the occurrence of VAP. For example, when the retention time of VAC is ≥2h, the positive rate of bacterial culture can reach 100%, and the positive rate of bacterial culture on the environmental surface after the condensate is retained for ≥2h and dumped is 78%. At the same time, gentamicin, as a broad-spectrum aminoglycoside antibiotic, has been studied in the prevention of VAP by nebulization, but the method of directly adding it to the condensate pot has not been reported. Therefore, the present invention aims to provide a new and more effective method for preventing VAP. Summary of the invention

[0004] Purpose of the Invention The main purpose of the present invention is to provide an efficient, accurate and innovative method for preventing ventilator-associated pneumonia (VAP), namely the gentamicin condensate pot method. Through this method, it is expected to significantly reduce the incidence of VAP, shorten the patient's mechanical ventilation time and ICU hospitalization time, reduce the use of antibiotics, while reducing medical costs, and provide new theoretical basis and practical guidance for the prevention of VAP.

[0005] In order to solve the above technical problems, the present invention is solved by the following technical solution: a gentamicin condensation pot method, comprising the following steps:

[0006] S1. Patient selection and grouping;

[0007] S2, control experiment process;

[0008] S3. Monitoring and recording;

[0009] S4. Analysis and evaluation.

[0010] Preferably, the specific method in the step of S1, patient selection and grouping, is as follows;

[0011] Eligible patients were divided into an experimental group and a control group according to the random number table method. The eligible patients were required to be aged >18 years, have no lung infection before admission to the ICU, have mechanical ventilation for more than 48 hours, and have voluntary consent from their family members or patients and sign an informed consent form. Patients with a history of chronic respiratory diseases, long-term hospital stays, atelectasis, or repeated aspiration of cerebral infarction or cerebral hemorrhage were excluded.

[0012] Preferably, the specific method in the step of S2, control experiment process is as follows;

[0013] Gentomycin 80,000 U (2 ml) was added to the ventilator condenser used by the patients in the experimental group every 12 hours, and 0.9% sodium chloride injection 2 ml was added to the condenser used by the patients in the control group every 12 hours.

[0014] Preferably, the specific method in the step S3, monitoring and recording, is as follows;

[0015] The incidence and diagnosis time distribution of VAP, mechanical ventilation time, ICU stay, total hospital stay and antibiotic use were monitored and compared between the two groups. Condensate water, environmental surface of objects in the condensation pot, and lower respiratory tract secretions were collected daily for pathogen detection. Body temperature, airway secretions, lung signs, blood routine, blood gas analysis, procalcitonin, and high-sensitivity CRP were monitored daily, and bedside chest X-rays were reviewed every three days.

[0016] Preferably, the specific method in said S4, analysis and evaluation step is as follows;

[0017] The clinical effect, safety and economic feasibility of this method were evaluated based on the monitoring results.

[0018] Preferably, the pathogen detection includes detection of colony count, type and drug resistance.

[0019] Preferably, the evaluation of clinical effect includes comprehensively evaluating the effect of the gentamicin condensate pot method in preventing VAP by comparing the differences between the two groups in various indicators.

[0020] Preferably, the safety assessment includes close monitoring of potential drug-related adverse reactions and analysis of the effect of topical use of gentamicin on the development of drug resistance.

[0021] Preferably, the economic feasibility assessment includes calculating the implementation cost of the gentamicin condensate pot method and evaluating the medical cost savings brought about by VAP prevention.

[0022] Compared with the prior art, the present invention has the following beneficial effects:

[0023] 1. The present invention achieves a continuous bactericidal effect of antibiotics in condensed water by adding gentamicin to the ventilator condenser, so that the antibiotics can act on bacteria in the ventilator pipeline for a long time, thereby effectively reducing the incidence of VAP. Clinical trial results can confirm that this method can significantly shorten the mechanical ventilation time and ICU hospitalization time, reduce the use rate of antibiotics, reduce ICU hospitalization costs, and improve the prognosis of mechanically ventilated patients, providing an effective solution for the prevention of VAP;

[0024] 2. Gentamicin acts directly on the ventilator circuit and respiratory tract, which may achieve higher local concentrations. Compared with traditional systemic medication or nebulized inhalation, this targeted drug delivery method improves the preventive effect. At the same time, local medication reduces systemic exposure, thereby reducing the occurrence of systemic adverse reactions and improving patient tolerance and treatment safety;

[0025] 3. It is only necessary to add antibiotics when replacing the condensing pot, without the need for additional complicated drug administration operations, which greatly reduces the workload of medical staff and makes this method easy to promote and apply in clinical practice, especially in busy medical environments such as ICU, where its simple operation highlights its advantages.

[0026] 4. Combined with the etiological monitoring of condensed water, the impact of intervention measures on respiratory flora can be directly observed, providing an objective basis for evaluating the prevention effect. By monitoring the changes in pathogens in condensed water, early warning of VAP can be achieved, so that medical staff can take appropriate treatment measures in time. According to the results of etiological monitoring, prevention strategies can be adjusted in time. For example, the dosage of gentamicin can be adjusted or other antibiotics can be replaced according to the type of bacteria and drug resistance, so as to achieve personalized and precise prevention, improve the prevention effect and reduce the occurrence of drug resistance. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] Figure 1 This is a distribution table for the detection of pathogens in ventilator condensate (VAC) of the present invention;

[0028] Figure 2 The results of the pathogen detection of the ventilator condensate (VAC) of the present invention;

[0029] Figure 3 This is the pathogen detection result after adding gentamicin sulfate injection to the present invention. DETAILED DESCRIPTION

[0030] Unless the context clearly dictates otherwise, unmodified nouns and nouns modified by "the" include singular and plural referents.

[0031] As used in the specification and claims, the terms "comprises," "comprising," "having," "may," "containing," and variations thereof as used herein refer to open transitional phrases, terms, or words that require the presence of specified ingredients / steps and allow for the presence of other ingredients / steps. However, such descriptions should be interpreted as also describing compositions or methods as "consisting of" and "consisting essentially of" the recited ingredients / steps, which allows for the presence of only the specified ingredients / steps and any unavoidable impurities that may result therefrom, and excludes other ingredients / steps.

[0032] Numerical values ​​in the specification and claims of this application should be understood to include the same numerical values ​​when reduced to the same number of significant figures and numerical values ​​that differ from the stated value by less than the experimental error of ordinary measurement techniques of the type described in this application for determining the stated value.

[0033] All ranges disclosed herein are inclusive of the indicated endpoints and are independently combinable (eg, the range of "2 grams to 10 grams" includes the endpoints 2 grams and 10 grams, and all intermediate values).

[0034] The terms "about" and "approximately" can be used to include any numerical value that can be varied without changing the basic function of the value. When used with a range, "about" and "approximately" also disclose the range defined by the absolute values ​​of the two endpoints, for example, "about 2 to about 4" also discloses a range of "2 to 4". Generally, the terms "about" and "approximately" can refer to ±10% of the indicated number. However, for temperature, the term "approximately" refers to ±1°C.

[0035] Unless expressly stated otherwise, the percentages of elements are to be considered as percentages by weight of the alloy in question.

[0036] The present disclosure may refer to the temperature of certain method steps. It should be noted that these specifications generally refer to the temperature set by the heat source (such as a furnace), and not necessarily the temperature that the heated material must reach.

[0037] The gentamicin condensation pot method comprises the following steps:

[0038] The condensing pot used in the present invention is a conventional component in a ventilator system, and gentamicin sulfate injection is added into the condensing pot.

[0039] S1. Patient selection and grouping;

[0040] Eligible patients were divided into the experimental group and the control group according to the random number table method. The eligible patients were required to be aged >18 years, without lung infection before admission to the ICU, mechanical ventilation for more than 48 hours, and voluntary consent from family members or patients and signed informed consent. Patients with chronic respiratory diseases, long-term hospital stay, atelectasis, or repeated aspiration of cerebral infarction or cerebral hemorrhage were excluded;

[0041] Patients who met the inclusion criteria were randomly divided into an experimental group (condensation pot plus gentamicin) and a control group (condensation pot plus 0.9% sodium chloride injection) according to the random number table method, with 120 cases in each group, and a total of at least 240 subjects.

[0042] S2, control experiment process;

[0043] Gentomycin 80,000 U (2 ml) was added to the ventilator condenser used by the patients in the experimental group every 12 hours, and 0.9% sodium chloride injection 2 ml was added to the condenser used by the patients in the control group every 12 hours.

[0044] S3, monitoring and recording;

[0045] The incidence and diagnosis time distribution of VAP, mechanical ventilation time, ICU stay, total hospital stay and antibiotic use were monitored and compared between the two groups. Condensate water, environmental surface of objects in the condensation pot, and lower respiratory tract secretions were collected daily for pathogen detection. Body temperature, airway secretions, lung signs, blood routine, blood gas analysis, procalcitonin, and high-sensitivity CRP were monitored daily, and bedside chest X-rays were reviewed every three days.

[0046] S4. Analysis and evaluation;

[0047] Evaluate the clinical efficacy, safety, and economic feasibility of the method based on the monitoring results;

[0048] By comparing the differences in the above clinical indicators between the experimental group and the control group, the clinical effect of gentamicin condensation pot method in preventing VAP was comprehensively evaluated;

[0049] Closely monitor potential drug-related adverse reactions and evaluate the impact on patients' lung function. At the same time, regularly conduct pathogen susceptibility testing and analyze the impact of topical gentamicin on the development of drug resistance to comprehensively evaluate the safety and long-term feasibility of this method;

[0050] The implementation cost of the gentamicin condensate pot method was calculated, including the cost of condensate testing and gentamicin, and the medical cost savings brought about by VAP prevention were evaluated, such as the cost of reducing the treatment costs of VAP-related complications and the cost saved by shortening the hospitalization period. The economic feasibility of the method was evaluated by comparing the intervention cost with the economic benefits brought about by VAP prevention.

[0051] Example:

[0052] 1. Research preparation stage (about 1 month)

[0053] 1. Personnel training: clarify the division of labor and organize technical and theoretical training for medical staff. The training content includes detailed explanation of the research plan, mastery of patient inclusion and exclusion criteria, measurement methods of various monitoring indicators, and specifications for data recording and processing, etc., to ensure that all medical staff have a deep understanding and mastery of the trial plan and can perform various operations accurately.

[0054] 2. Sample size estimation and grouping: A randomized, controlled, single-center study was adopted. For the main clinical efficacy indicators, according to the bilateral significance level α and the test power 1-β, under the assumption that the two groups had different overall rates and sample size ratios, the PASS15.0 software was used to estimate the sample size required for each group in this trial. According to the ventilator-associated pneumonia (VAP) mortality rate of 30%, the sample size ratio of the two groups was 1:1, at the test level α = 0.05 (bilateral test), the test power 1-β = 0 .8. When the dropout rate (DR) of the two groups is 10%, it is estimated that the sample size N required for this study is 216 cases. Considering the sample content after dropout, N: = N / (1-DR) = 216 / (1-0.1) = 240 cases, that is, the research subjects are at least 240 cases, 120 cases in each group. Then, the eligible patients are divided into the experimental group and the control group according to the random number table method. In the grouping process, the strictness of randomization must be ensured to avoid any influence of human factors on the grouping results.

[0055] 2. Clinical trial stage (12-18 months)

[0056] 1. Patient care and intervention: The selected patients were given routine artificial airway care, including pulmonary drainage measures such as suctioning, turning over and patting the back, and vibrating the sputum with a sputum vibrator, as well as humidification and heating of the artificial airway. The condensate of the ventilator was emptied once it was full. At the same time, the condensate pot was treated according to the grouping. Gentomycin was added to the condensate pot of the experimental group, and sodium chloride injection was added to the condensate pot of the control group. Both operations were performed every 12 hours. During the nursing process, the patient's condition should be closely observed and the data of various monitoring indicators should be recorded in a timely manner.

[0057] 2. Data collection: During the clinical trial, various indicator data were continuously collected, including basic information (age, gender, APACHEⅡ score, SOFA score, comorbidities), incidence of ventilator-associated pneumonia (VAP), mechanical ventilation time, antibiotic use time, ICU hospitalization time, ICU hospitalization costs, daily pathogen detection data (colony count, type and drug resistance), daily relevant physiological indicator data (body temperature, airway secretions, lung signs, blood routine, blood gas analysis, procalcitonin, high-sensitivity CRP) and chest X-ray data every three days. Data collection must ensure accuracy and completeness. Any missing or erroneous data may affect the final research results.

[0058] 3. Data collection method: The condensed water in the condenser pots at the exhalation and inhalation ends of each patient was collected three times according to different retention times, namely 1, 2 and 3 hours. After the water samples of the condensed water retained in the condenser pots at the exhalation and inhalation ends of the ventilator for 2 hours were poured out, the surface of the environment in the ventilator pipeline was sampled for bacterial culture. The sample collection was completed by 2 operators. Under sterile operating conditions, 2 mL of condensed water was extracted with a sterile syringe and injected into a sterile sampling bottle for inspection. The condensed water in the condenser pots at the exhalation and inhalation ends of the ventilator was retained for 2 hours. Before pouring, a disposable treatment towel was laid flat under the condenser pots at the exhalation and inhalation ends. After pouring, according to the sampling method for the surface of environmental objects in the ventilator pipeline, a sterile cotton swab was dipped in sterile saline and rubbed on the surface of the treatment towel to obtain samples for inspection. A disposable sputum suction device was used to obtain samples of the lower respiratory tract secretions of 240 patients through endotracheal intubation or tracheotomy, and the samples were sent to the microbiology laboratory for culture.

[0059] 4. Test methods: (1) Detection of total bacterial count: Prepare nutrient agar medium in advance, sterilize and set aside. In a sterile operating table, take 1 mL of condensed water and add it to a sterile plate. Pour 20-25 mL of cooled nutrient agar and gently shake the plate to mix. After the agar solidifies, place it in a constant temperature incubator at 35°C for 48 hours, count the colonies and calculate the total bacterial count; (2) Identification of bacterial species: Take another 100 μL of condensed water and inoculate it on a Columbia blood agar plate by spreading method. After incubation at 35°C for 48 hours, use MALDITOF-MS to identify the bacterial species; (3) Detection of patient sputum samples: Use sterile methods according to clinical laboratory operating procedures, take patient sputum samples and inoculate them on Columbia blood agar plates and Haemophilus influenzae plates. Place the inoculated plates in a CO2 incubator for 24 and 48 hours, respectively, and count the colonies and identify the bacterial species.

[0060] 3. Data analysis and summary stage (about 12 months)

[0061] 1. Preliminary data analysis: Use professional statistical analysis software to process and analyze the collected data, and compare and evaluate the primary and secondary endpoint indicators according to predetermined statistical methods.

[0062] 2. Continue to collect clinical data for clinical trials. At this stage, patients should continue to be cared for and intervened according to the trial plan, data should be continuously collected, and the data should be organized and analyzed in a timely manner.

[0063] 3. Comprehensively summarize the research results and evaluate the effectiveness, safety, and feasibility of the gentamicin condensate pot method in preventing VAP.

[0064] The specific data are as follows

[0065] During the preparatory trial phase, the research team collected ventilator condensate (VAC) samples from mechanically ventilated patients in the ICU of our hospital from January to August 2024, and conducted bacterial culture and drug sensitivity tests. The results showed that pathogens, including drug-resistant bacteria, could be detected in ventilator condensate samples, and the bacterial species were highly correlated with the pathogenic bacteria spectrum of VAP, verifying the reliability of ventilator condensate (VAC) as a VAP etiology monitoring sample. Figure 1 ;

[0066] After adding gentamicin sulfate injection to the ventilator condensate (VAC), the ventilator condensate (VAC) sample was cultured again. The results showed that no bacterial growth was cultured. Figure 2 and Figure 3 .

[0067]

[0068]

[0069]

[0070]

[0071] The preliminary test results verified that pathogenic bacteria were detected in ventilator condensate (VAC) samples, and gentamicin sulfate injection can basically cover the above pathogenic bacteria. In theory, adding gentamicin to the condensate pot can inhibit the pathogenic bacteria in the condensate, thereby reducing the incidence of VAP caused by condensate.

[0072] Finally, it should be noted that the above is only a preferred embodiment of the present invention and is not intended to limit the present invention. Although the present invention has been described in detail with reference to the aforementioned embodiments, it is still possible for those skilled in the art to modify the technical solutions described in the aforementioned embodiments or to make equivalent substitutions for some of the technical features therein. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principles of the present invention should be included in the protection scope of the present invention.

Claims

1. Gentamicin condensation pot method, characterized in that, The following steps are involved: S1. Patient selection and grouping; S2, control experiment process; S3, monitoring and recording; S4. Analysis and evaluation.

2. The gentamicin condensation pot method according to claim 1, characterized in that: The specific method in the step S1, patient selection and grouping, is as follows; Eligible patients were divided into an experimental group and a control group according to the random number table method. The eligible patients were required to be aged >18 years, have no lung infection before admission to the ICU, have mechanical ventilation for more than 48 hours, and have voluntary consent from their family members or patients and sign an informed consent form. Patients with a history of chronic respiratory diseases, long-term hospital stays, atelectasis, or repeated aspiration of cerebral infarction or cerebral hemorrhage were excluded.

3. The gentamicin condensation pot method according to claim 1, characterized in that: The specific methods in the steps of S2 and control experiment are as follows: Gentomycin 80,000 U (2 ml) was added to the ventilator condenser used by the patients in the experimental group every 12 hours, and 0.9% sodium chloride injection 2 ml was added to the condenser used by the patients in the control group every 12 hours.

4. The gentamicin condensation pot method according to claim 1, characterized in that: The specific methods in the step S3, monitoring and recording are as follows; The incidence and diagnosis time distribution of VAP, mechanical ventilation time, ICU stay, total hospital stay and antibiotic use were monitored and compared between the two groups. Condensate water, environmental surface of objects in the condensation pot, and lower respiratory tract secretions were collected daily for pathogen detection. Body temperature, airway secretions, lung signs, blood routine, blood gas analysis, procalcitonin, and high-sensitivity CRP were monitored daily, and bedside chest X-rays were reviewed every three days.

5. The gentamicin condensation pot method according to claim 1, characterized in that: The specific methods in the S4, analysis and evaluation steps are as follows; The clinical effect, safety and economic feasibility of this method were evaluated based on the monitoring results.

6. The gentamicin condensation pot method according to claim 4, characterized in that: The pathogen detection includes detection of colony count, type and drug resistance.

7. The gentamicin condensation pot method according to claim 5, characterized in that: The evaluation of clinical effect includes comprehensively evaluating the effect of gentamicin condensation pot method in preventing VAP by comparing the differences between the two groups in various indicators.

8. The gentamicin condensation pot method according to claim 5, characterized in that: The safety assessment included close monitoring of potential drug-related adverse reactions and analysis of the effect of topical gentamicin on the development of drug resistance.

9. The gentamicin condensation pot method according to claim 5, characterized in that: The economic feasibility assessment included calculating the implementation cost of the gentamicin condensate pot method and evaluating the healthcare cost savings resulting from VAP prevention.

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