The Efficiency of Chest Physiotherapy Applied in a Different Order
Comparison of the Efficiency of Chest Physiotherapy Applied in a Different Order in Pediatric Intensive Care Patients
調査の概要
詳細な説明
42 children who complied with the inclusion criteria will be included in the study. The mother or father of the children hospitalized in the pediatric intensive care unit of the hospital where the study is conducted will be given information about the study and asked to sign the "Informed Voluntary Consent Form". After the family's approval, they will be asked to fill out the "Parent Introductory Information Form".
The randomization method will be used to create the control group and the study group. Children to be included in the study will be placed in the groups with the randomized controlled method with 21 children in each group. The randomization of the study will be made with the online program available at the URL address https://www.randomizer.org/. Before entering the sample size in the program, lots will be drawn, and the 1st set will be assigned to the control group, and the 2nd set will be assigned to the study group. In order to determine in which group the children involved in the study will be placed, numbers from 1 to 42 will be entered into the program without repetition. Children that will constitute the study group through the program will be randomly distributed into 2 groups.
The control group (n=21) will be administered the inhaler drug routinely administered in the intensive care unit where the study is conducted and then receive chest physiotherapy (tapotement or vibration), then nasopharyngeal and oropharyngeal aspiration. The study group (n=21) will first receive chest physiotherapy (tapotement or vibration) and aspiration, followed by inhaler drug therapy.
The "Patient Data Collection Forms" of both groups will be filled out. Chest physiotherapy will follow the "Tapotement and Vibration Application Procedure," and aspiration will follow the "Nasopharyngeal and Oropharyngeal Aspiration Application Procedure". The "Patient Physiologic Parameter Assessment Form" information will be recorded before the application and 30 minutes after the application. It is known that the stress hormones epinephrine and norepinephrine half-life is 1-3 minutes, and it is believed that after a stressful invasive intervention, the release of stress hormones increases but turns back to their normal levels in 15-20 minutes (Puntillo et al. 2001). Based on this information, vital findings will be recorded in the "Patient Physiologic Parameter Assessment Form" after 30 minutes.
Obtained data will be evaluated using necessary statistical tests in the computer environment. Evaluation methods will be selected considering if data is distributed homogenously. If it has a homogenous distribution, parametric tests will be used. If it does not have a homogenous distribution, non-parametric methods will be used.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
-
İstanbul、七面鳥、34010
- Selmin Köse
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Hospitalized patients at Cerrahpaşa Faculty of Medicine Pediatric Intensive Care Unit 1,
- Aged between 1 months-6 years,
- Having been in intensive care for at least two days,
- Concious pediatric patient,
- Receiving supplemental oxygen therapy with non-invasive mechanical ventilation or an oxygen mask,
- Being administered chest physiotherapy (Tapotement or Vibration),
- Being administered oropharyngeal and nasopharyngeal aspiration,
- Inhaler drug therapy included in the patient's order,
- Parents, volunteering for the study.
Exclusion Criteria:
- Parents not volunteering for the study,
- Patients younger than 1-month or older than 6-years old,
- Not receiving supplemental oxygen therapy with non-invasive mechanical ventilation or an oxygen mask
- Not being administered oropharyngeal and nasopharyngeal aspiration,
- Inhaler drug therapy is not included in the physician's order.
研究計画
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:単一グループの割り当て
- マスキング:ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
実験的:Chest Physiotherapy- Aspiration- Inhaler drugs group
The study group (n=21) will first receive chest physiotherapy (tapotement or vibration) and aspiration, followed by inhaler drug therapy.
|
In the intensive care unit where the study was conducted, the patients who have a respiratory disorder and receive supplemental oxygen therapy with non-invasive mechanical ventilation or an oxygen mask are first administered an inhaler drug therapy placed in the physician's order.
It is followed by chest physiotherapy and then oropharyngeal and nasopharyngeal aspiration.
However, in practice rendered by the researcher, it is suggested that when chest physiotherapy and aspiration are administered in the first place and then followed by an inhaler drug therapy, it might have a more positive impact on the patient's physiologic parameters.
|
他の:Inhaler drugs- Chest Physiotherapy- Aspiration group
The control group (n=21) will be administered the inhaler drug routinely administered in the intensive care unit where the study is conducted and then receive chest physiotherapy (tapotement or vibration), then nasopharyngeal and oropharyngeal aspiration
|
In the intensive care unit where the study was conducted, the patients who have a respiratory disorder and receive supplemental oxygen therapy with non-invasive mechanical ventilation or an oxygen mask are first administered an inhaler drug therapy placed in the physician's order.
It is followed by chest physiotherapy and then oropharyngeal and nasopharyngeal aspiration.
However, in practice rendered by the researcher, it is suggested that when chest physiotherapy and aspiration are administered in the first place and then followed by an inhaler drug therapy, it might have a more positive impact on the patient's physiologic parameters.
|
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 |
---|---|---|
Physiological Parameter Assessment Form Showing The Change In Heart Rate
時間枠:This procedure will be applied to each patient for 30 minutes 4 times a day. It will be applied for at least 2 days and until the patient is discharged.
|
Chest physiotherapy applied in a different order in pediatric intensive care patients causes a difference in the patient's physiologic parameters.This form prepared by the researcher includes recording pulse rate/min in the clinic.
The researcher will be assessed the pulse/min at least four times before and after the chest physiotherapy in a day.
The "Patient Physiologic Parameter Assessment Form" information will be recorded before the application and 20 minutes after the application.
It is known that the stress hormones epinephrine and norepinephrine half-life is 1-3 minutes, and it is believed that after a stressful invasive intervention, the release of stress hormones increases but turns back to their normal levels in 15-20 minutes.
Based on this information, the pulse will be recorded in the "Patient Physiologic Parameter Assessment Form" after 20 minutes.
|
This procedure will be applied to each patient for 30 minutes 4 times a day. It will be applied for at least 2 days and until the patient is discharged.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Physiological Parameter Assessment Form Showing The Change In SPO2%
時間枠:This procedure will be applied to each patient for 30 minutes 4 times a day. It will be applied for at least 2 days and until the patient is discharged.
|
Chest physiotherapy applied in a different order in pediatric intensive care patients causes a difference in the patient's physiologic parameters.This form prepared by the researcher includes recording SPO2% in the clinic.
The researcher will be assessed the SPO2% at least four times before and after the chest physiotherapy in a day.
The "Patient Physiologic Parameter Assessment Form" information will be recorded before the application and 30 minutes after the application.
It is known that the stress hormones epinephrine and norepinephrine half-life is 1-3 minutes, and it is believed that after a stressful invasive intervention, the release of stress hormones increases but turns back to their normal levels in 15-20 minutes.
Based on this information, the SPO2% will be recorded in the "Patient Physiologic Parameter Assessment Form" after 30 minutes.
|
This procedure will be applied to each patient for 30 minutes 4 times a day. It will be applied for at least 2 days and until the patient is discharged.
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Physiological Parameter Assessment Form Showing The Change In Respiration rate/min
時間枠:This procedure will be applied to each patient for 30 minutes 4 times a day. It will be applied for at least 2 days and until the patient is discharged.
|
Chest physiotherapy applied in a different order in pediatric intensive care patients causes a difference in the patient's physiologic parameters.This form prepared by the researcher includes recording respiration rate/min in the clinic.
The researcher will be assessed the respiration rate/min at least four times before and after the chest physiotherapy in a day.
The "Patient Physiologic Parameter Assessment Form" information will be recorded before the application and 30 minutes after the application.
It is known that the stress hormones epinephrine and norepinephrine half-life is 1-3 minutes, and it is believed that after a stressful invasive intervention, the release of stress hormones increases but turns back to their normal levels in 15-20 minutes.
Based on this information, the respiration rate/min will be recorded in the "Patient Physiologic Parameter Assessment Form" after 30 minutes.
|
This procedure will be applied to each patient for 30 minutes 4 times a day. It will be applied for at least 2 days and until the patient is discharged.
|
Physiological Parameter Assessment Form Showing The Change In Blood pressure (mmHg)
時間枠:This procedure will be applied to each patient for 30 minutes 4 times a day. It will be applied for at least 2 days and until the patient is discharged.
|
Chest physiotherapy applied in a different order in pediatric intensive care patients causes a difference in the patient's physiologic parameters.This form prepared by the researcher includes recording respiration blood pressure (mmHg) in the clinic.
The researcher will be assessed the blood pressure (mmHg) at least four times before and after the chest physiotherapy in a day.
The "Patient Physiologic Parameter Assessment Form" information will be recorded before the application and 30 minutes after the application.
It is known that the stress hormones epinephrine and norepinephrine half-life is 1-3 minutes, and it is believed that after a stressful invasive intervention, the release of stress hormones increases but turns back to their normal levels in 15-20 minutes.
Based on this information, the blood pressure (mmHg) will be recorded in the "Patient Physiologic Parameter Assessment Form" after 30 minutes.
|
This procedure will be applied to each patient for 30 minutes 4 times a day. It will be applied for at least 2 days and until the patient is discharged.
|
Physiologic Parameter Assessment Form Showing The Change In Blood gas (mmHg)
時間枠:The blood gas will driven twice a day routinely.
|
In the clinic, although the time varies depending on the physician's request, the blood gas will driven twice a day routinely.
|
The blood gas will driven twice a day routinely.
|
協力者と研究者
スポンサー
捜査官
- 主任研究者:SEVVAL UNAL, RN、İstanbul University-Cerrahpaşa Cerrahpaşa School of Medicine
出版物と役立つリンク
便利なリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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。
呼吸器疾患の臨床試験
-
Adelphi Values LLCBlueprint Medicines Corporation完了肥満細胞性白血病 (MCL) | 攻撃的な全身性肥満細胞症 (ASM) | SM w Assoc Clonal Hema Non-mast Cell Lineage Disease (SM-AHNMD) | くすぶり全身性肥満細胞症 (SSM) | 無痛性全身性肥満細胞症 (ISM) ISM サブグループが完全に募集されましたアメリカ