Construction and Effect Evaluation of Integrated Care Model for Pulmonary Infection in Stroke Patients With Tracheotomy

NCT ID: NCT05505487

Last Updated: 2022-08-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-07
• Study Completion Date: 2026-05-07

Brief 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 tracheotomy.

3. To evaluate the clinical application effect of integrated care model of pulmonary infection in stroke patients with tracheotomy.

Detailed Description

1. Research content This study involves two parts: construction and effect evaluation.

1. The construction link includes: retrospective analysis of patient data, clinical observation, literature review, expert consultation, and pre-experiment.

2. 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.

2. 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.

3. Sample Size Estimation

1. 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.

2. 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.

4. 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

control group

Implement routine nursing such as: routine oral nursing, tracheostomy, dressing change, sputum suction nursing, oral education, etc.

Group Type: NO_INTERVENTION

No interventions assigned to this group

intervention group

Implement comprehensive nursing models such as: admission risk assessment, personalized oral care based on beck oral score, aspiration prevention, airway care, diversified health education

Group Type: EXPERIMENTAL

integrated care model

Intervention Type: OTHER

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.

Interventions

integrated care model

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shenzhen Second People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yan Gao, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Shenzhen Second People's Hospital

Locations

The Second People's Hospital of Shenzhen

Shenzhen, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yan Gao, Ph.D

Role: CONTACT

gaoyanluoyang@163.com

+8613660367430

Facility Contacts

Ph.D

Role: primary

gaoyanluoyang@163.com

+8613660367430

Other Identifiers

20220324004-FS01

Identifier Type: -

Identifier Source: org_study_id