The Effect of Care Protocol on the Outcomes of Patients With Lung Surgery
2021年7月23日 更新者：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
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (予想される)
80
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：DİLARA SOYDAN, Master
- 電話番号：03243610001
- メール：dilarasoydan@hotmail.com
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～80年 (大人、高齢者)
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
介入なし：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.
|
|
|
実験的：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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Pulmonary function test values evaluated using the care protocol
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Mobilization evaluated using the care protocol
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- スタディディレクター：GÜLAY ALTUN UĞRAŞ, Doctorate、Researcher
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (予想される)
2021年8月28日
一次修了 (予想される)
2022年8月28日
研究の完了 (予想される)
2022年12月30日
試験登録日
最初に提出
2021年7月7日
QC基準を満たした最初の提出物
2021年7月23日
最初の投稿 (実際)
2021年7月27日
学習記録の更新
投稿された最後の更新 (実際)
2021年7月27日
QC基準を満たした最後の更新が送信されました
2021年7月23日
最終確認日
2021年7月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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