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Patient OutcomesNCT04978935

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

A study testing Care protocol in people with Patient Outcomes, run by Mersin University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Patient Outcomes
What is being tested?
Care protocol
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
No sites listed yet
Study dates
28 Aug 2021to 30 Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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,
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  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • Non chest tube,
  • Metastatic disease,
  • Emergency thoracotomy applied,
  • Patients staying in the intensive care unit for more than one day.

Trial locations and contacts

No sites are listed yet.

DİLARA SOYDAN, Master contact

03243610001

dilarasoydan@hotmail.com

About this study

Official title: 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

Read the 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.

Being tested
Care protocol
Keywords
Thoracotomy, Care protocol, Nursing, Nursing care, Respiratory functions

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Care protocolOther

    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.

Study groups in NCT04978935
Study groupRoleWhat they receive
Control groupNo interventionIn 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.
InterventionExperimentalCare 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.
Receives: Other: Care protocol

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Change from before implementation preoperative and postoperative (1.,5.) days and an average of 2 weeks

Secondary outcomes (4)

  1. Mobilization evaluated using the care protocol

    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

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

  2. Prevention of complications evaluated using the care protocol

    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.

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

  3. Chest tube removal evaluated using the care protocol

    The time of chest tube removal and the day will be recorded in the Patient Results Form

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

  4. Discharge time evaluated using the care protocol

    The time of discharge will be recorded in the Patient Results Form

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2021
  2. Study start28 Aug 2021 (estimated)
  3. Primary completion28 Aug 2022 (estimated)
  4. Study completion30 Dec 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Prospective, parallel, two arm, randomized controlled,single blind
Masking
Single blind
Who is masked
Participant
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04978935
Sponsor's protocol ID
MersinUniversityNursingFaculty
Status last verified
Jul 2021
First submitted
7 Jul 2021
Last updated
27 Jul 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Care protocol in people with Patient Outcomes, run by Mersin University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 27 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact DİLARA SOYDAN, Master (03243610001, dilarasoydan@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pulmonary function test values evaluated using the care protocol (time frame: Change from before implementation preoperative and postoperative (1.,5.) days and an average of 2 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04978935.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2021.

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