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

23 juli 2021 bijgewerkt door: Dilara Soydan, Mersin University

Improving Pulmonary Function The Effect of Care Protocol on the Outcomes of Patients With Thoracotomy

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

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Verwacht)

80

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 80 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Geen tussenkomst: 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.
Experimenteel: 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.
Ander: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Pulmonary function test values evaluated using the care protocol
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Mobilization evaluated using the care protocol
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Mersin University

Onderzoekers

  • Studie directeur: GÜLAY ALTUN UĞRAŞ, Doctorate, Researcher

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Verwacht)

28 augustus 2021

Primaire voltooiing (Verwacht)

28 augustus 2022

Studie voltooiing (Verwacht)

30 december 2022

Studieregistratiedata

Eerst ingediend

7 juli 2021

Eerst ingediend dat voldeed aan de QC-criteria

23 juli 2021

Eerst geplaatst (Werkelijk)

27 juli 2021

Updates van studierecords

Laatste update geplaatst (Werkelijk)

27 juli 2021

Laatste update ingediend die voldeed aan QC-criteria

23 juli 2021

Laatst geverifieerd

1 juli 2021

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • MersinUniversityNursingFaculty

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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