- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT04978935
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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Studietyp
Inskrivning (Förväntat)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: DİLARA SOYDAN, Master
- Telefonnummer: 03243610001
- E-post: dilarasoydan@hotmail.com
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Inget ingripande: 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.
|
|
Experimentell: 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.
|
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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Pulmonary function test values evaluated using the care protocol
Tidsram: Change from before implementation preoperative and postoperative (1.,5.) days and an average of 2 weeks
|
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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Mobilization evaluated using the care protocol
Tidsram: Change from before implementation and postoperative (0.,1.,2.,3.,4.,5.) days and an average of 2 weeks
|
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
Tidsram: Change from before implementation and postoperative (0.,1.,2.,3.,4.,5.) days and an average of 2 weeks
|
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
Tidsram: Change from before implementation and postoperative (0.,1.,2.,3.,4.,5.) days and an average of 2 weeks
|
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
Tidsram: Change from before implementation and postoperative (0.,1.,2.,3.,4.,5.) days and an average of 2 weeks
|
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
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studierektor: GÜLAY ALTUN UĞRAŞ, Doctorate, Researcher
Studieavstämningsdatum
Studera stora datum
Studiestart (Förväntat)
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
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