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

NCT05505487 | Recruiting

• 1 other identifier: 20220324004-FS01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.To understand the occurrence of pulmonary infection in stroke patients with tracheotomy, and to clarify the current situation of clinical nursing.
2. 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. 3.To evaluate the clinical application effect of integrated care model of pulmonary infection in stroke patients with tracheotomy.

Conditions

Stroke; Pulmonary Infection

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  3 weeks after admission

Secondary Outcomes (6)

• Beck Oral Assessment Score(BOAS)，modified

  Within 1 week of admission

• Beck Oral Assessment Score(BOAS)，modified

  3 weeks after admission

• Zarit Caregiver Burden Interview, ZBI

  Within 1 week of admission

• Zarit Caregiver Burden Interview, ZBI

  3 weeks after admission

• EuroQol-5 Dimension， EQ-5D

  Within 1 week of admission

Other Outcomes (1)

• hospital costs

  ≥3 weeks

Study Arms (2)

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

Other: integrated care model

Interventions

integrated care model 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.

intervention group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shenzhen Second People's Hospital: lead

Study Sites (1)

The Second People's Hospital of Shenzhen

Shenzhen, Guangdong, 518035, China

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Yan Gao, Ph.D

  Shenzhen Second People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yan Gao, Ph.D

CONTACT

+8613660367430; gaoyanluoyang@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is a quasi-experimental study; no equal control design

Study Record Dates

• First Submitted: May 14, 2022
• First Posted: August 17, 2022
• Study Start: May 7, 2022
• Primary Completion: May 7, 2026
• Study Completion: May 7, 2026
• Last Updated: August 17, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)