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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Patient Outcomes
• Intervention / Treatment: Other: Care protocol

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.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: DİLARA SOYDAN, Master; Phone Number: 03243610001; Email: dilarasoydan@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.
Experimental: 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.	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mersin University
• Investigators: Study Director: GÜLAY ALTUN UĞRAŞ, Doctorate, Researcher

Study record dates

Study Major Dates

• Study Start (Anticipated): August 28, 2021
• Primary Completion (Anticipated): August 28, 2022
• Study Completion (Anticipated): December 30, 2022

Study Registration Dates

• First Submitted: July 7, 2021
• First Submitted That Met QC Criteria: July 23, 2021
• First Posted (Actual): July 27, 2021

Study Record Updates

• Last Update Posted (Actual): July 27, 2021
• Last Update Submitted That Met QC Criteria: July 23, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Nursing; Thoracotomy; Nursing care; Care protocol; Respiratory functions
• Other Study ID Numbers: MersinUniversityNursingFaculty

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No