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

NCT ID: NCT04978935

Last Updated: 2021-07-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-28
• Study Completion Date: 2022-12-30

Brief 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

Detailed 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.

Conditions

Patient Outcomes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Control group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention

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.

Group Type: EXPERIMENTAL

Care protocol

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mersin University

OTHER

Sponsor Role: lead

Responsible Party

Dilara Soydan

Nursing researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

GÜLAY ALTUN UĞRAŞ, Doctorate

Role: STUDY_DIRECTOR

Researcher

Central Contacts

DİLARA SOYDAN, Master

Role: CONTACT

dilarasoydan@hotmail.com

03243610001

Other Identifiers

MersinUniversityNursingFaculty

Identifier Type: -

Identifier Source: org_study_id