The Effect of Care Protocol on the Outcomes of Patients With Lung Surgery

Study Overview
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Brief Summary
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This randomized controlled trial evaluates the effect of the care protocol, which consists of independent nursing interventions, which play an important role in accelerating the recovery process of the patient, such as the patient's position, mobilization, use of spirometry, and providing shoulder exercises after thoracotomy. The hypothesis of this research is; the care protocol applied to the patients after thoracotomy has an effect on the patients' pulmonary function tests (FVC, FEV1, FEV1/FVC) and on the mobilization of the patients, the development of complications, the time of chest tube removal and the discharge

Detailed Description
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Methods: In the study, 80 patients were randomly assigned to the study and control groups. Nursing interventions will be applied to the patients included in the study group (n=40), starting from the 0th day (the first day spent in the intensive care unit) after the thoracotomy in line with the prepared care protocol application steps until discharge. maintenance protocol; It will consist of position of the patient, mobilization, use of spirometer and shoulder exercises. The primary outcome of the research is the effect of the maintenance protocol used in the improvement of respiratory function on respiratory function tests. The secondary outcome of the research is to determine the effect of the care protocol on mobilization, complication development status, chest tube removal and discharge time in patients. The results are obtained by recording PFT values on the 1st, 5th and discharge days before and after thoracotomy. Postoperative (0.,1.,2.,3.,4.,5.) days and discharge day; mobilization, complication development status, chest tube removal time and discharge date will be recorded on the Patient Results Form.

Official Title
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Improving Pulmonary Function The Effect of Care Protocol on the Outcomes of Patients With Thoracotomy

Conditions
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Patient Outcomes

Intervention / Treatment
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* Other: Care protocol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Accepting to participate in the research, 18 years and older, Conscious, oriented and cooperative, Able to speak and understand Turkish, Does not have any psychiatric disease, Elective thoracotomy performed, Chest tube inserted, Patients who were followed up in the intensive care unit on the first day after surgery and admitted to the clinic the next day Patients without a history of metastatic disease Exclusion Criteria: Those who do not accepted to participate in the research, Under 18 years of age, Unconscious, without orientation and cooperation, Who cannot speak or understand Turkish, Having a psychiatric problem, Non thoracotomy Non chest tube, Metastatic disease, Emergency thoracotomy applied, Patients staying in the intensive care unit for more than one day.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, parallel, two arm, randomized controlled,single blind
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>In the control group (n=40), interventions for the position, mobilization and spirometry of the patient are applied to all patients in the clinic where the study was conducted. However, these applications are not made in accordance with a certain order and protocol. Shoulder exercises are not routinely taught to patients. In the study, no additional application will be made to the control group other than the routine treatment and care practice of the clinic. | |
| Experimental: Intervention<br>Care protocol will be applied to the study group (n=40), starting from the first day spent in the intensive care unit.Care protocol consists of patient's position, mobilization, use of spirometer and shoulder exercises. The bed head of the patient will be raised 30°-45° in line with the application steps. In the study, the patient's in-bed and out-of-bed mobilization will be provided by considering the mobilization application steps, and the patient will be asked to stay out of bed for two hours on the 0 th day after surgery. The patient will be asked to stay out of bed for six hours from the first postoperative day until discharge. After the thoracotomy, the conditions that the doctor considers as complications will be recorded.The time of chest tube removal and the day of discharge will be recorded. In the study, the use of spirometry and shoulder exercises will be carried out by taking into account the implementation steps of the care protocol. | Other: Care protocol<br>* Before starting the application, the investigator (DS) will fill out the Introductory Characteristics Form of all patients, the Pre-thoracotomy Pulmonary Function Test (PFT) section of the Patient Results Form. The PFT section will be re-evaluated on the 1st, 5th day and on the day of discharge after thoracotomy. Nursing interventions will be applied to the study group (n=40), starting from the 0th day (the first day spent in the intensive care unit) after the thoracotomy in line with the prepared care protocol application steps until discharge. Care protocol consists of patient's position, mobilization, use of spirometer and shoulder exercises.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary function test values evaluated using the care protocol | Pulmonary function tests. Pulmonary function tests will be measured with a portable pulmonary function tester. In the evaluation, FVC (%), FEV1 (%) and FEV1/FVC (%) parameters will be used | Change from before implementation preoperative and postoperative (1.,5.) days and an average of 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mobilization evaluated using the care protocol | In the study, the patient's in-bed and out-of-bed mobilization will be provided by considering the mobilization application steps, and the patient will be asked to stay out of bed for two hours on the 0 th day after surgery. In the clinic, the patient will be mobilized in line with the mobilization application steps. The patient will be asked to stay out of bed for six hours from the first postoperative day until discharge. The steps taken will be recorded with the pedometer | Change from before implementation and postoperative (0.,1.,2.,3.,4.,5.) days and an average of 2 weeks | 
| Prevention of complications evaluated using the care protocol | After the thoracotomy, the conditions that the doctor considers as complications (atelectasis, pneumonia, air leak, bronchospasm, subcutaneous emphysema, atrial fibrillation) will be recorded and daily evaluation will be made. | Change from before implementation and postoperative (0.,1.,2.,3.,4.,5.) days and an average of 2 weeks | 
| Chest tube removal evaluated using the care protocol | The time of chest tube removal and the day will be recorded in the Patient Results Form | Change from before implementation and postoperative (0.,1.,2.,3.,4.,5.) days and an average of 2 weeks | 
| Discharge time evaluated using the care protocol | The time of discharge will be recorded in the Patient Results Form | Change from before implementation and postoperative (0.,1.,2.,3.,4.,5.) days and an average of 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thoracotomy, Care protocol, Nursing, Nursing care, Respiratory functions