Lung Expansion TherapyNCT06041295
Quality Improvement Project of Nurse Guiding Incentive Spirometry After Cardiac Surgery
A study testing on-the-job training of lung expansion therapy in people with Lung Expansion Therapy and Post-cardiac Surgery, run by National Taiwan University Hospital.
Trial summary
Studies have shown that patients undergoing general anesthesia surgery are prone to pulmonary complications after surgery; about 30-72% of cardiac surgery patients have postoperative chest X-rays that reveal lung collapse, leading to gas exchange disorders and hypoxemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Expansion Therapy, Post-cardiac Surgery
- What is being tested?
- on-the-job training of lung expansion therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 6 Sep 2023to 31 Jan 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Nurse staff in cardiovascular surgery ICU of National Taiwan University Hospital
- 18 years of age and above
- Perform cardiovascular surgeries at National Taiwan University Hospital
- After surgery, the endotracheal tube is inserted and admitted to the cardiovascular surgery intensive care unit, and the endotracheal tube is removed in the intensive care unit.
- There is a clinical indication to perform lung expansion therapy
- Clear consciousness and able to cooperate with instructions
Who cannot join
- None
- Patients:
- Hemodynamic instability (mean arterial pressure remains below 60 mmHg after infusion or vasopressor administration)
- Severe lung diseases (such as uncontrollable asthma, severe pulmonary obstruction, untreated pneumothorax, etc.)
- Unable to perform effective deep breathing (for example: vital capacity is less than 10 ml/kg or inspiratory capacity is less than 1/3 of the predicted value)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Interprofessional Collaborative Practice Between Respiratory Therapists and Nurses- Quality Improvement Project of the Correct Rate of Nurse Guiding Incentive Spirometry After Cardiac Surgery
Studies have shown that patients undergoing general anesthesia surgery are prone to pulmonary complications after surgery; about 30-72% of cardiac surgery patients have postoperative chest X-rays that reveal lung collapse, leading to gas exchange disorders and hypoxemia. Postoperative lung expansion therapy can increase ventilation-perfusion balance, increase lung volume, promote respiratory mucosal sputum production and reduce postoperative pain, and has been proven to improve postoperative pulmonary-related complications.
Inducement spirometry is currently one of the mainstream methods of performing lung expansion treatment. It uses visual feedback to allow the patient to perform slow, deep breathing with sufficient airflow or volume to achieve the lung expansion effect; it is also used after cardiac surgery in our hospital. The main way for patients to perform lung expansion therapy; compared with only performing respiratory exercises after surgery, induced spirometry can reduce the incidence of lung collapse and respiratory distress in postoperative patients, and can also shorten the ICU stay and total hospitalization stay.
Read more
Most cardiac surgery patients in our hospital are given health education on lung expansion therapy by nursing staff before and after surgery. This unit does not have specialized courses on lung expansion therapy, which may lead to differences in explanations between different nursing staff; some patients' lack of knowledge and understanding of lung expansion treatment resulted in the treatment effect not being as good as expected, which motivated the author to formulate a project for improvement. We hope to analyze, review and improve the current situation to improve the effectiveness of lung expansion treatment for patients.
Based on the current situation analysis and relevant literature, a project to improve nursing guidance for lung expansion therapy was implemented.
Read the detailed description
The following options were selected as solutions:
- Develop Inducement Spirometry Care Standards
- Organize in-service education courses on pulmonary dilatation therapy for nursing staff
- Make a health education leaflet on incentive spirometer and place it in the ward for patients to read.
- Provide demonstration materials for nursing staff to experience the treatment process
The main purposes are:
- Improve nursing staff's awareness of lung expansion therapy
- Improve the accuracy of nursing staff in performing lung expansion therapy and health education
- Improve the accuracy of patients' lung expansion therapy
- Reduce the incidence of pulmonary complications in patients after cardiac surgery
- Conditions
- Lung Expansion Therapy, Post-cardiac Surgery
- Being tested
- on-the-job training of lung expansion therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
on-the-job training of lung expansion therapyBehavioural
on-the-job training of lung expansion therapy
| Study group | Role | What they receive |
|---|---|---|
| the cardiovascular surgery ICU nurse staff | Experimental | on-the-job training of lung expansion therapy Receives: Behavioral: on-the-job training of lung expansion therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The improvement of nursing staff's awareness rate of lung expansion therapy
The improvement before and after on-the-job training
Measured: week 2 after on-the-job training
The improvement of nursing staff's correct rate of education of lung expansion therapy
The improvement before and after on-the-job training
Measured: week 2 after on-the-job training
Secondary outcomes (3)
The improvement of patients' correct rate of lung expansion therapy
The improvement before and after nurse staff's on-the-job training
Measured: week 2 after nurse staff's on-the-job training
The improvement of respiratory complication rate
The improvement before and after nurse staff's on-the-job training
Measured: week 2 after nurse staff's on-the-job training
Nurses' satisfaction of the quality improvement project survey
Nurses' satisfaction of the quality improvement project
Measured: week 2 after nurse staff's on-the-job training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2023
- Study start6 Sep 2023 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Expansion TherapyStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06041295
- Sponsor's protocol ID
- 202308062RINB
- Status last verified
- Sep 2023
- First submitted
- 11 Sep 2023
- Last updated
- 18 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interprofessional Collaborative Practice Between Respiratory Therapists and Nurses- Quality Improvement Project of the Correct Rate of Nurse Guiding Incentive Spirometry After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT06041295
- Acronym / sponsor ID
- 202308062RINB
- Conditions
- Lung Expansion Therapy, Post-cardiac Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 6 Sep 2023 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Jan 2024 (estimated)
- First posted
- 18 Sep 2023 (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.
Studies have shown that patients undergoing general anesthesia surgery are prone to pulmonary complications after surgery; about 30-72% of cardiac surgery patients have postoperative chest X-rays that reveal lung collapse, leading to gas exchange disorders and hypoxemia. Postoperative lung expansion therapy can increase ventilation-perfusion balance, increase lung volume, promote respiratory mucosal sputum production and reduce postoperative pain, and has been proven to improve postoperative pulmonary-related complications.
Inducement spirometry is currently one of the mainstream methods of performing lung expansion treatment. It uses visual feedback to allow the patient to perform slow, deep breathing with sufficient airflow or volume to achieve the lung expansion effect; it is also used after cardiac surgery in our hospital. The main way for patients to perform lung expansion therapy; compared with only performing respiratory exercises after surgery, induced spirometry can reduce the incidence of lung collapse and respiratory distress in postoperative patients, and can also shorten the ICU stay and total hospitalization stay.
Most cardiac surgery patients in our hospital are given health education on lung expansion therapy by nursing staff before and after surgery. This unit does not have specialized courses on lung expansion therapy, which may lead to differences in explanations between different nursing staff; some patients' lack of knowledge and understanding of lung expansion treatment resulted in the treatment effect not being as good as expected, which motivated the author to formulate a project for improvement. We hope to analyze, review and improve the current situation to improve the effectiveness of lung expansion treatment for patients.
Based on the current situation analysis and relevant literature, a project to improve nursing guidance for lung expansion therapy was implemented.
Detailed description
The following options were selected as solutions:
- Develop Inducement Spirometry Care Standards
- Organize in-service education courses on pulmonary dilatation therapy for nursing staff
- Make a health education leaflet on incentive spirometer and place it in the ward for patients to read.
- Provide demonstration materials for nursing staff to experience the treatment process
The main purposes are:
- Improve nursing staff's awareness of lung expansion therapy
- Improve the accuracy of nursing staff in performing lung expansion therapy and health education
- Improve the accuracy of patients' lung expansion therapy
- Reduce the incidence of pulmonary complications in patients after cardiac surgery
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| the cardiovascular surgery ICU nurse staff | Experimental | Behavioral: on-the-job training of lung expansion therapyon-the-job training of lung expansion therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Nurse staff in cardiovascular surgery ICU of National Taiwan University Hospital
- 18 years of age and above
- Perform cardiovascular surgeries at National Taiwan University Hospital
- After surgery, the endotracheal tube is inserted and admitted to the cardiovascular surgery intensive care unit, and the endotracheal tube is removed in the intensive care unit.
- There is a clinical indication to perform lung expansion therapy
Key exclusion criteria (5 listed)
- None
- Hemodynamic instability (mean arterial pressure remains below 60 mmHg after infusion or vasopressor administration)
- Severe lung diseases (such as uncontrollable asthma, severe pulmonary obstruction, untreated pneumothorax, etc.)
- Unable to perform effective deep breathing (for example: vital capacity is less than 10 ml/kg or inspiratory capacity is less than 1/3 of the predicted value)
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 |
|---|---|---|
| on-the-job training of lung expansion therapyon-the-job training of lung expansion therapy | Behavioural | the cardiovascular surgery ICU nurse staff |
Primary outcome
The improvement of nursing staff's awareness rate of lung expansion therapy
Time frame: week 2 after on-the-job training
The improvement before and after on-the-job training
The improvement of nursing staff's correct rate of education of lung expansion therapy
Time frame: week 2 after on-the-job training
The improvement before and after on-the-job training
3 secondary outcomes
The improvement of patients' correct rate of lung expansion therapy
Time frame: week 2 after nurse staff's on-the-job training
The improvement of respiratory complication rate
Time frame: week 2 after nurse staff's on-the-job training
Nurses' satisfaction of the quality improvement project survey
Time frame: week 2 after nurse staff's on-the-job training
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2023.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing on-the-job training of lung expansion therapy in people with Lung Expansion Therapy and Post-cardiac Surgery, run by National Taiwan University Hospital.
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 6 inclusion and 5 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 18 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Yi-Ting Hung, Bachelor (+886-910720142, birdymkii@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The improvement of nursing staff's awareness rate of lung expansion therapy (time frame: week 2 after on-the-job training). 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 18 Sep 2023.