StrokeNCT05505487
Construction and Effect Evaluation of Integrated Care Model for Pulmonary Infection in Stroke Patients With Tracheotomy
A study testing integrated care model in people with Stroke and Pulmonary Infection, run by Shenzhen Second People's Hospital at 1 site in China.
Trial summary
1. To understand the occurrence of pulmonary infection in stroke patients with tracheotomy, and to clarify the current situation of clinical nursing. 2. Construct a standardized, systematic and scientific integrated care model to control the severity of pulmonary infection in non-acute stroke patients with simple… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Stroke, Pulmonary Infection
- What is being tested?
- integrated care model
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 7 May 2022to 7 May 2026
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non-acute stroke patients diagnosed by MRI or CT who meet the diagnostic criteria of the "Chinese Guidelines for the Prevention and Treatment of Cerebrovascular Diseases";
- Those who meet the diagnostic criteria for pulmonary infection;
- Age ≥18 years old;
- Tracheotomy patients who have been off the ventilator or do not need mechanical ventilation;
- Patients who can cooperate with the research and sign the informed consent.
Who cannot join
- Patients whose vital signs are unstable and may be transferred to ICU for treatment in the future;
- Patients with malignant tumors or other infectious diseases.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Second People's Hospital of Shenzhen
Shenzhen, Guangdong, 518035
Ph.D, +8613660367430, gaoyanluoyang@163.com
About this study
- To understand the occurrence of pulmonary infection in stroke patients with tracheotomy, and to clarify the current situation of clinical nursing.
- Construct a standardized, systematic and scientific integrated care model to control the severity of pulmonary infection in non-acute stroke patients with simple tracheotomy.
- To evaluate the clinical application effect of integrated care model of pulmonary infection in stroke patients with tracheotomy.
Read the detailed description
- Research content This study involves two parts: construction and effect evaluation.
- The construction link includes: retrospective analysis of patient data, clinical observation, literature review, expert consultation, and pre-experiment.
- Effect evaluation: The integrated care model was applied to the clinic, and the patients' CPIS score, Beck oral score, ZBI caregiver burden score, EQ-5D score and hospitalization cost were collected to evaluate the effect of the model.
- The grouping method Convenience sampling method was used to select patients with simple tracheotomy for non-acute stroke who were admitted to the Department of Rehabilitation Medicine of Shenzhen Second People's Hospital as the research object, and the patients before the implementation of the integrated care model(May-July 2022) were set as the control group , the patients after the implementation of the integrated care model (August-October 2022) were set as the intervention group.
- Sample Size Estimation
- This study is a quasi-experimental study, and the main outcome indicator is the control of pulmonary infection (CPIS score). Therefore, the sample size estimation method of the group design quantitative data sample mean is adopted.
- Based on the results reported in similar research literature, the authors assumed that the CPIS scores of the control group and the intervention group were 3.9±1.5 and 2.8±1.1, respectively. Set β=0.1, power (Power=1-β)=90%, two-sided α=0.05 at the significance level, and the sample size of each group was 32 cases after calculation by G-power3.1 software. According to the 20% dropout rate, the final sample size of each group was 40 cases, and there were 80 cases in the two groups.
- Statistical analysis Using Excel and IBM SPSS Statistics 26.0 software for double entry and analysis, the measurement data that conformed to the normal distribution were expressed as the mean ± standard deviation, and the t test was used for comparison between groups; the measurement data that did not conform to the normal distribution were expressed as the median and four The number of quantiles was expressed, and the rank-sum test was used for comparison between groups. The count data were expressed as frequency and percentage, and the chi-square test was used for comparison between groups. The difference was statistically significant with p<0.05.
- Conditions
- Stroke, Pulmonary Infection
- Being tested
- integrated care model
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
integrated care modelOther
The interventions in this study were to implement basic patient care only and did not involve any invasive procedures. On the basis of routine nursing, the content of nursing intervention was integrated, and a standardized nursing model was formed for clinical application to control the severity of pulmonary infection in patients with simple tracheotomy in the non-acute phase of stroke.
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | Implement routine nursing such as: routine oral nursing, tracheostomy, dressing change, sputum suction nursing, oral education, etc. |
| intervention group | Experimental | Implement comprehensive nursing models such as: admission risk assessment, personalized oral care based on beck oral score, aspiration prevention, airway care, diversified health education Receives: Other: integrated care model |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Pulmonary Infection Score
The scale mainly includes 7 indicators of body temperature, white blood cell count, tracheal secretions, oxygenation, chest X-ray, progress of pulmonary exudation, and microbial culture of tracheal aspirates, each with 0 to 2 points, with a total score of 12 If the score is less than 6, the lung infection is considered to be controlled.
Measured: Within 1 week of admission
Clinical Pulmonary Infection Score
The scale mainly includes 7 indicators of body temperature, white blood cell count, tracheal secretions, oxygenation, chest X-ray, progress of pulmonary exudation, and microbial culture of tracheal aspirates, each with 0 to 2 points, with a total score of 12 If the score is less than 6, the lung infection is considered to be controlled.
Measured: 3 weeks after admission
Secondary outcomes (6)
Beck Oral Assessment Score(BOAS)，modified
The scale includes five items: lips, gums and oral mucosa, tongue, teeth, and saliva to evaluate the oral hygiene status and functional status. Each item is scored with 1 to 4 points, and the total oral hygiene score is 5 to 20 points. The higher the score, the worse the oral hygiene.
Measured: Within 1 week of admission
Beck Oral Assessment Score(BOAS)，modified
The scale includes five items: lips, gums and oral mucosa, tongue, teeth, and saliva to evaluate the oral hygiene status and functional status. Each item is scored with 1 to 4 points, and the total oral hygiene score is 5 to 20 points. The higher the score, the worse the oral hygiene.
Measured: 3 weeks after admission
Zarit Caregiver Burden Interview, ZBI
The scale mainly includes 2 dimensions (personal burden and responsibility burden), a total of 22 items, each item is divided into 5 grades according to the severity of the burden, expressed on a scale of 0-4, 0 means never, 4 means almost often. The total score of the scale is 0-88 points, and the higher the score, the heavier the burden of care.
Measured: Within 1 week of admission
Zarit Caregiver Burden Interview, ZBI
The scale mainly includes 2 dimensions (personal burden and responsibility burden), a total of 22 items, each item is divided into 5 grades according to the severity of the burden, expressed on a scale of 0-4, 0 means never, 4 means almost often. The total score of the scale is 0-88 points, and the higher the score, the heavier the burden of care.
Measured: 3 weeks after admission
EuroQol-5 Dimension， EQ-5D
he Chinese version of the European five-dimensional health scale (EuroQol-5 Dimension, EQ-5D), EQ-5D is a commonly used scale to measure health-related quality of life. The scale is divided into 2 parts: the EQ-5D health description system and the EuroQol-Visual Analogue Score (EQ-VAS). The EQ-5D health description system includes 5 dimensions: mobility, self-care, activities of daily living, pain or discomfort, anxiety or depression, and each dimension contains 3 levels: no difficulty, some difficulty, and extreme difficulty. The EQ-VAS uses a score of 0 to 100 to evaluate a patient's current health status, with 100 representing the "best health status in my mind" and 0 representing the "worst health status in my mind".
Measured: Within 1 week of admission
EuroQol-5 Dimension， EQ-5D
he Chinese version of the European five-dimensional health scale (EuroQol-5 Dimension, EQ-5D), EQ-5D is a commonly used scale to measure health-related quality of life. The scale is divided into 2 parts: the EQ-5D health description system and the EuroQol-Visual Analogue Score (EQ-VAS). The EQ-5D health description system includes 5 dimensions: mobility, self-care, activities of daily living, pain or discomfort, anxiety or depression, and each dimension contains 3 levels: no difficulty, some difficulty, and extreme difficulty. The EQ-VAS uses a score of 0 to 100 to evaluate a patient's current health status, with 100 representing the "best health status in my mind" and 0 representing the "worst health status in my mind".
Measured: 3 weeks after admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2022
- Study start7 May 2022
- Primary completion7 May 2026 (estimated)
- Study completion7 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This study is a quasi-experimental study; no equal control design
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Second People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yan Gao, Ph.D, Principal investigator, Shenzhen Second People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05505487
- Sponsor's protocol ID
- 20220324004-FS01
- Status last verified
- May 2022
- First submitted
- 14 May 2022
- Last updated
- 17 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Contact the principal investigator for data if necessary
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction and Effect Evaluation of Integrated Care Model for Pulmonary Infection in Stroke Patients With Tracheotomy
- ClinicalTrials.gov ID
- NCT05505487
- Acronym / sponsor ID
- 20220324004-FS01
- Conditions
- Stroke, Pulmonary Infection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Shenzhen Second People's HospitalUniversity, hospital or other
- Study start
- 7 May 2022 (actual)
- Primary completion
- 7 May 2026 (estimated)
- Study completion
- 7 May 2026 (estimated)
- First posted
- 17 Aug 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.
- To understand the occurrence of pulmonary infection in stroke patients with tracheotomy, and to clarify the current situation of clinical nursing.
- Construct a standardized, systematic and scientific integrated care model to control the severity of pulmonary infection in non-acute stroke patients with simple tracheotomy.
- To evaluate the clinical application effect of integrated care model of pulmonary infection in stroke patients with tracheotomy.
Detailed description
- Research content This study involves two parts: construction and effect evaluation.
- The construction link includes: retrospective analysis of patient data, clinical observation, literature review, expert consultation, and pre-experiment.
- Effect evaluation: The integrated care model was applied to the clinic, and the patients' CPIS score, Beck oral score, ZBI caregiver burden score, EQ-5D score and hospitalization cost were collected to evaluate the effect of the model.
- The grouping method Convenience sampling method was used to select patients with simple tracheotomy for non-acute stroke who were admitted to the Department of Rehabilitation Medicine of Shenzhen Second People's Hospital as the research object, and the patients before the implementation of the integrated care model(May-July 2022) were set as the control group , the patients after the implementation of the integrated care model (August-October 2022) were set as the intervention group.
- Sample Size Estimation
- This study is a quasi-experimental study, and the main outcome indicator is the control of pulmonary infection (CPIS score). Therefore, the sample size estimation method of the group design quantitative data sample mean is adopted.
- Based on the results reported in similar research literature, the authors assumed that the CPIS scores of the control group and the intervention group were 3.9±1.5 and 2.8±1.1, respectively. Set β=0.1, power (Power=1-β)=90%, two-sided α=0.05 at the significance level, and the sample size of each group was 32 cases after calculation by G-power3.1 software. According to the 20% dropout rate, the final sample size of each group was 40 cases, and there were 80 cases in the two groups.
- Statistical analysis Using Excel and IBM SPSS Statistics 26.0 software for double entry and analysis, the measurement data that conformed to the normal distribution were expressed as the mean ± standard deviation, and the t test was used for comparison between groups; the measurement data that did not conform to the normal distribution were expressed as the median and four The number of quantiles was expressed, and the rank-sum test was used for comparison between groups. The count data were expressed as frequency and percentage, and the chi-square test was used for comparison between groups. The difference was statistically significant with p<0.05.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study is a quasi-experimental study; no equal control design
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –Implement routine nursing such as: routine oral nursing, tracheostomy, dressing change, sputum suction nursing, oral education, etc. |
| intervention group | Experimental | Other: integrated care modelImplement comprehensive nursing models such as: admission risk assessment, personalized oral care based on beck oral score, aspiration prevention, airway care, diversified health education |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Non-acute stroke patients diagnosed by MRI or CT who meet the diagnostic criteria of the "Chinese Guidelines for the Prevention and Treatment of Cerebrovascular Diseases";
- Those who meet the diagnostic criteria for pulmonary infection;
- Age ≥18 years old;
- Tracheotomy patients who have been off the ventilator or do not need mechanical ventilation;
- Patients who can cooperate with the research and sign the informed consent.
Key exclusion criteria (2 listed)
- Patients whose vital signs are unstable and may be transferred to ICU for treatment in the future;
- Patients with malignant tumors or other infectious diseases.
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 |
|---|---|---|
| integrated care modelThe interventions in this study were to implement basic patient care only and did not involve any invasive procedures. On the basis of routine nursing, the content of nursing intervention was integrated, and a standardized nursing model was formed for clinical application to control the severity of pulmonary infection in patients with simple tracheotomy in the non-acute phase of stroke. | Other | intervention group |
Primary outcome
Clinical Pulmonary Infection Score
Time frame: Within 1 week of admission
The scale mainly includes 7 indicators of body temperature, white blood cell count, tracheal secretions, oxygenation, chest X-ray, progress of pulmonary exudation, and microbial culture of tracheal aspirates, each with 0 to 2 points, with a total score of 12 If the score is less than 6, the lung infection is considered to be controlled.
Clinical Pulmonary Infection Score
Time frame: 3 weeks after admission
The scale mainly includes 7 indicators of body temperature, white blood cell count, tracheal secretions, oxygenation, chest X-ray, progress of pulmonary exudation, and microbial culture of tracheal aspirates, each with 0 to 2 points, with a total score of 12 If the score is less than 6, the lung infection is considered to be controlled.
6 secondary outcomes
Beck Oral Assessment Score(BOAS)，modified
Time frame: Within 1 week of admission
Beck Oral Assessment Score(BOAS)，modified
Time frame: 3 weeks after admission
Zarit Caregiver Burden Interview, ZBI
Time frame: Within 1 week of admission
Zarit Caregiver Burden Interview, ZBI
Time frame: 3 weeks after admission
EuroQol-5 Dimension， EQ-5D
Time frame: Within 1 week of admission
EuroQol-5 Dimension， EQ-5D
Time frame: 3 weeks after admission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2022.
- Individual participant dataSharing planned: No. Contact the principal investigator for data if necessary
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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.
Yan Gao, Ph.D principal investigator
Shenzhen Second People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing integrated care model in people with Stroke and Pulmonary Infection, run by Shenzhen Second People's Hospital at 1 site in China.
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 5 inclusion and 2 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 17 Aug 2022. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yan Gao, Ph.D (+8613660367430, gaoyanluoyang@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Pulmonary Infection Score (time frame: Within 1 week of admission). 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?
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 17 Aug 2022.