Effectiveness of Inspiratory Muscle Training in Weaning ICU Patients (IMT in weaning)
調査の概要
詳細な説明
It is estimated that 40% of the duration of mechanical ventilation is devoted to the weaning process. A length of stay in the ICU of more than 7 days appears to be associated with a 27,9% risk of developing infections. Furthermore, the mortality rate is higher in patients with infections. Additionally, the daily cost of hospitalizing a patient on mechanical ventilation is estimated at €1,590-€1,657, while this varies depending on the interventions required. The burden on the National Health System from the prolonged stay of patients in the ICU, as well as from the complications that will arise, increases exponentially.
It has been found that implementing an IMT program can lead to rapid and successful extubation of the patient, while early mobilization can accelerate timely discharge from the ICU. This optimizes the cost-effectiveness ratio in intensive care units.
The investigators believe that implementing an IMT program will maximize the effectiveness of the early mobilization program for ICU patients. Thus, the investigators believe it will provide valuable insights into the rehabilitation needs of critically ill patients, contributing to earlier weaning from mechanical ventilation and transition to the next level of care. The investigators hypothesize that the implementation of such an intervention program will reduce the length of hospital stay, while also lowering the cost of daily care.
This is a randomized control trial that investigates the effectiveness of an inspiratory muscle training program in successful weaning of mechanically ventilated patients for at least 72 hours. Both experimental groups will receive a protocolised early mobilization program. IMT intervention will be applied till ICU discharge once a day for 5 days/week initiating with a load of 40% of maximal inspiratory pressure (MIP). Primary outcome will be a successful weaning from MV. And secondary includes MV duration, MIP, maximal expiratory pressure (MEP), ICU and hopsital length of stay.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：IRINI PATSAKI, PhD
- 電話番号：+30 6942064363
- メール：ipatsaki@uniwa.gr
研究場所
-
-
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Chalcis、ギリシャ
- 募集
- General Hospital
-
コンタクト：
- Stiliani Andreadou, MSc
- 電話番号：+306942064363
- メール：s.andreadou@gmail.com
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Nikaia、ギリシャ
- 募集
- General Hospital "Agios Panteleimon"
-
コンタクト：
- Stavroula Fokidi, MSc
- 電話番号：+306942064363
- メール：sfokidi@uniwa.gr
-
主任研究者：
- Stavroula Fokidi, MSc
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- ≥ 72h invasive mechanical ventilation
- adequate co-operativeness as assessed by 5SQ ≥ 3.
Exclusion Criteria:
- terminal condition or palliative care
- neuromuscular or neurological conditions prior to ICU admission
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：並列代入
- 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：IMT Group
Inspiratory muscle training will be performed using an electronic breathing trainer (40% of MIP, with a daily increase of 10% of the initial MIP) and 30 repetitions, organized into 3 sets of 10 repetitions with a 1-minute break between sets. Additional, a protocolized early mobilization program will be perfromed. |
Inspiratory muscle training will be performed using an electronic breathing trainer (40% of MIP, with a daily increase of 10% of the initial MIP) and 30 repetitions, organized into 3 sets of 10 repetitions with a 1-minute break between sets
Protocolized early mobilization program
|
|
アクティブコンパレータ：Control Group
A protocolized early mobilization program
|
Protocolized early mobilization program
|
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 |
|---|---|---|
|
Weaning sucess
時間枠：immediately after intervention
|
Successful weaning is defined as the removal of the endotracheal tube with no ventilator support for 48 hours following its removal
|
immediately after intervention
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Weaning duration
時間枠：immediately after intervention
|
Duration of weaning procedure
|
immediately after intervention
|
|
Maximal Inspiratory Pressure
時間枠：1st day (baseline), immediately after intervention
|
Maximal inspiratory Pressure
|
1st day (baseline), immediately after intervention
|
|
Maximal expirartory pressure
時間枠：1st day (baseline), immediately after intervention
|
1st day (baseline), immediately after intervention
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
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
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。