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

NCT04978935 | Unknown DMC

• 1 other identifier: MersinUniversityNursingFaculty
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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

Conditions

Patient Outcomes

Keywords

Thoracotomy; Care protocol; Nursing; Nursing care; Respiratory functions

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Mobilization evaluated using the care protocol

  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

  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

  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

  Change from before implementation and postoperative (0.,1.,2.,3.,4.,5.) days and an average of 2 weeks

Study Arms (2)

Control group

NO INTERVENTION

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.

Intervention

EXPERIMENTAL

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

Interventions

Care protocol 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.

Intervention

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Accepting to participate in the research,
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mersin University: lead

MeSH Terms

Interventions

CARE protocol

Study Officials

• GÜLAY ALTUN UĞRAŞ, Doctorate

  Researcher

  STUDY DIRECTOR

Central Study Contacts

DİLARA SOYDAN, Master

CONTACT

03243610001; dilarasoydan@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nursing researcher

Model Details: Prospective, parallel, two arm, randomized controlled,single blind

Study Record Dates

• First Submitted: July 7, 2021
• First Posted: July 27, 2021
• Study Start: August 28, 2021
• Primary Completion: August 28, 2022
• Study Completion: December 30, 2022
• Last Updated: July 27, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share