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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04978935
Enrollment
80
Registered
2021-07-27
Start date
2021-08-28
Completion date
2022-12-30
Last updated
2021-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patient Outcomes

Keywords

Thoracotomy, Care protocol, Nursing, Nursing care, Respiratory functions

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.

Interventions

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.

Sponsors

Mersin University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Masking description

80 patients by randomization will be divided into groups A and B. Group A will be determined as the study group and group B as the control group. The information showing the nurses included in the research sample is assigned to the A and B groups will be put in an opaque envelope. This envelope will be kept by the coordinator researcher (GAU). When the researcher (DS) goes to the patient for the application, after filling the Informed Consent Form, she will open the envelope and find out which group the patient is in. The participants will be blinded. The researcher (DS), on the other hand, cannot be blinded due to the nature of the research. When the research is completed, the data will be transferred to the computer environment by a statistician who does not know the A and B groups, and the data will be analyzed by a statistician independent of the research and the findings will be reported.

Intervention model description

Prospective, parallel, two arm, randomized controlled,single blind

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Pulmonary function test values evaluated using the care protocolChange from before implementation preoperative and postoperative (1.,5.) days and an average of 2 weeksPulmonary 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

Secondary

MeasureTime frameDescription
Mobilization evaluated using the care protocolChange from before implementation and postoperative (0.,1.,2.,3.,4.,5.) days and an average of 2 weeksIn 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
Prevention of complications evaluated using the care protocolChange from before implementation and postoperative (0.,1.,2.,3.,4.,5.) days and an average of 2 weeksAfter 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.
Chest tube removal evaluated using the care protocolChange from before implementation and postoperative (0.,1.,2.,3.,4.,5.) days and an average of 2 weeksThe time of chest tube removal and the day will be recorded in the Patient Results Form
Discharge time evaluated using the care protocolChange from before implementation and postoperative (0.,1.,2.,3.,4.,5.) days and an average of 2 weeksThe time of discharge will be recorded in the Patient Results Form

Contacts

Primary ContactDİLARA SOYDAN, Master
dilarasoydan@hotmail.com03243610001

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026