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

Patient Outcomes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04978935
• Other study ID #: MersinUniversityNursingFaculty
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 28, 2021
• Est. completion date: December 30, 2022

Study information

• Verified date: July 2021
• Source: Mersin University
• Contact: DILARA SOYDAN, Master
• Phone: 03243610001
• Email: dilarasoydan[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: December 30, 2022
• Est. primary completion date: August 28, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Patient Outcomes

Intervention

Other:
• Care protocol
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mersin University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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