Impact of an Electronic Monitoring Device on Maintaining a Correct Elevation of Head of Bed for Mechanically-ventilated Patients in Intensive Care Unit (Inclinometre2)
Maintaining mechanically-ventilated patients in semi-recumbent position (defined by a head of bed inclination between 30° and 45°) would decrease the risk of pneumopathy occurrence in those patients. However, such a bed inclination frame is still difficult to maintain in day-to-day care.
The aim of the study is to evaluate the impact of an electronic monitoring device on the proportion of time spent per day in semi-recumbent position, as defined by a head of bed inclination between 40° and 50°, in mechanically-ventilated patients.
調査の概要
詳細な説明
Maintaining semi-recumbent position (defined by a head of bed inclination between 40° and 50°) is an international guidance to prevent ventilator-associated pneumopathy which is the main nosocomial infection in intensive care unit. However, maintaining such an inclination has been shown to be difficult in day-to-day care.
This could be improved by using an assistance device that would measure inclination of the head of bed in real time and trigger an alarm when the value order is not reached, hence allowing a quick readjustment if necessary.
The investigators want to evaluate en electronic monitoring device (EMD) that is removable and adjustable to all beds, which would allow a whole intensive care unit to be fully equipped at low cost.
Hypothesis : using an EMD could improve the proportion of time spent per day in semi-recumbent position (defined by a head of bed inclination between 40° and 50°) in mechanically-ventilated patients.
Primary objective : to evaluate the impact of an EMD with alarm on the proportion of time spent per day in semi-recumbent position, as defined by a head of bed inclination between 40° and 50°, in mechanically-ventilated patients.
Secondary objectives :
- to evaluate the impact of the EMD on the head of bed inclination overall mean
- to evaluate the impact of the EMD on the proportion of time spent per day with a head of bed inclination superior to 30°
- to evaluate the impact of the EMD on the proportion of time spent per day with a head of bed inclination between 30° and 45°
- to study factors associated to a head of bed inclination inferior to 30° for more than 12hrs per 24hrs
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
-
-
-
Paris、フランス、75018
- Hopital Bichat Claude Bernard
-
-
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:
- patient with invasive mechanical ventilation
- expected mechanical ventilation duration for more than 48h after inclusion
- signature of an informed consent by a relative
- patient affiliated to a social security scheme (beneficiary or assignee)
Exclusion Criteria:
- age<18 years old
- mechanical ventilation with tracheotomy
- contraindication to semirecumbent position (e.g., spinal cord injury, important sacral bedsore, counterpulsation balloon, femoral cannulation for extracorporeal circulation) or expected indication to another position within the following 48 h after inclusion (e.g., ventral decubitus for hypoxemia pulmonary pathology)
- SAPS II score > 65 at the admission (moribund patients)
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：クロスオーバー割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
他の：EMD (Inclinomax) then usual care
EMD (electronic monitoring device) : recording the head of bed inclination degree with digital display and alarm on for 24h. Usual care : recording the head of bed inclination degree with masked digital display and alarm off for 24h. |
EMD (electronic monitoring device) : recording the head of bed inclination degree with digital display and alarm on
他の名前：
|
|
他の：usual care then EMD (Inclinomax)
Usual care : recording the head of bed inclination degree with masked digital display and alarm off for 24h. EMD (electronic monitoring device) : recording the head of bed inclination degree with digital display and alarm on for 24h. |
EMD (electronic monitoring device) : recording the head of bed inclination degree with digital display and alarm on
他の名前：
|
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 |
|---|---|---|
|
proportion of time spent per day in semirecumbent position as defined by a head of bed inclination between 40° and 50°
時間枠：24hrs
|
head of bed inclination recording during 24h
|
24hrs
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
head of bed inclination overall mean
時間枠：24hrs
|
head of bed inclination recording during 24h
|
24hrs
|
|
proportion of time spent per day with a head of bed inclination superior to 30°
時間枠：24hrs
|
head of bed inclination recording during 24h
|
24hrs
|
|
proportion of time spent per day with a head of bed inclination between 30° and 45°
時間枠：24hrs
|
head of bed inclination recording during 24h
|
24hrs
|
協力者と研究者
捜査官
- 主任研究者：Lila BOUADMA, MD、Assistance Publique - Hôpitaux de Paris
研究記録日
主要日程の研究
研究開始
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 (見積もり)
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
その他の研究ID番号
- P080407
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