Clinical trial NCT04978935: The Effect of Care Protocol on the Outcomes of Patients With Lung Surgery
Official title: Improving Pulmonary Function The Effect of Care Protocol on the Outcomes of Patients With Thoracotomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Patient Outcomes
Keywords: Thoracotomy
Care protocol
Nursing
Nursing care
Respiratory functions
Lead sponsor: Mersin University
Sponsor class: OTHER
First posted: 2021-07-27
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, parallel, two arm, randomized controlled,single blind
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Pulmonary function test values evaluated using the care protocol
timeFrame: Change from before implementation preoperative and postoperative (1.,5.) days and an average of 2 weeks
Secondary outcomes:
measure: Mobilization evaluated using the care protocol
timeFrame: Change from before implementation and postoperative (0.,1.,2.,3.,4.,5.) days and an average of 2 weeks
measure: Prevention of complications evaluated using the care protocol
timeFrame: Change from before implementation and postoperative (0.,1.,2.,3.,4.,5.) days and an average of 2 weeks
measure: Chest tube removal evaluated using the care protocol
timeFrame: Change from before implementation and postoperative (0.,1.,2.,3.,4.,5.) days and an average of 2 weeks
measure: Discharge time evaluated using the care protocol
timeFrame: Change from before implementation and postoperative (0.,1.,2.,3.,4.,5.) days and an average of 2 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Researcher
name: GÜLAY ALTUN UĞRAŞ, Doctorate
role: STUDY_DIRECTOR
References: