- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Studietype
Registrering (Forventet)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: DİLARA SOYDAN, Master
- Telefonnummer: 03243610001
- E-post: dilarasoydan@hotmail.com
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Ingen inngripen: 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.
|
|
Eksperimentell: 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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Pulmonary function test values evaluated using the care protocol
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Mobilization evaluated using the care protocol
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: GÜLAY ALTUN UĞRAŞ, Doctorate, Researcher
Studierekorddatoer
Studer hoveddatoer
Studiestart (Forventet)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- MersinUniversityNursingFaculty
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