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Ventilation Weaning Strategies and Correlation to Outcomes in Tracheostomized Patients in the Lausanne ICU

2022年6月2日更新者：Piquilloud Imboden Lise

Analysis of Ventilation Weaning Strategies and Correlation to Outcomes in Tracheostomized Patients in the Intensive Care Unit of the Lausanne University Hospital

This retrospective study aims to study characteristics of patients tracheotomized in the Lausanne ICU, both overall and by primary reasons of intubation. Ventilation data both before and after tracheotomy, weaning technique and timing are studied in this retrospective study.

調査の概要

状態

完了

条件

研究の種類

観察的

入学 (実際)

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。

研究場所

スイス
- Vaud
  - Lausanne、Vaud、スイス、1011
    - Lausanne University Hospital

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年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

サンプリング方法

非確率サンプル

調査対象母集団

All patients admitted to the Lausanne ICU between May1st and November 31st who had a tracheotomy and were ventilated for more than 72 hours were screened for exclusion criterias. 147 patients were screened and 80 patients were included.

説明

Inclusion Criteria:

All patients hospitalized in the Lausanne ICU between May 1st 2017 and November 31st 2018 with a tracheotomy and mechanically ventilated more than 72 hours.

Exclusion Criteria:

Presence of a know opposition to participation to research projects
Patient tracheostomized specifically for ENT (ear-nose-throat) reason
Burn victim
Patient tracheostomized before his/her admission to the Lausanne ICU

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

グループ/コホートの数

コホートと介入

グループ/コホート
Intubation for respiratory reasons All patients who were intubated for respiratory reasons (i.e. acute respiratory distress syndrome, pneumonias, pleural effusions for example)
Intubation for neurological reasons All patients who were intubated for neurological reasons (i.e. stroke, intracranial bleeding, cervical fracture with tetraparesia for example)
Intubation for other reasons All patients who were intubated for other reasons than respiratory or neurological (i.e. intubation before surgery, cardiac arrest, hemodynamic instability and polytraumatism without respiratory distress or neurological pathology necessitating intubation)

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
Time from intubation to tracheotomy 時間枠：Once, between time of intubation to time of tracheotomy, up to 60 days	Calculated from clinical information system (time of intubation, time of tracheotomy), calculated in hours	Once, between time of intubation to time of tracheotomy, up to 60 days

二次結果の測定

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

Piquilloud Imboden Lise

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

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 (実際)

2021年6月10日

一次修了 (実際)

2022年5月15日

研究の完了 (実際)

2022年5月15日

試験登録日

最初に提出

2021年7月12日

QC基準を満たした最初の提出物

2021年8月2日

最初の投稿 (実際)

2021年8月3日

学習記録の更新

投稿された最後の更新 (実際)

2022年6月3日

QC基準を満たした最後の更新が送信されました

2022年6月2日

最終確認日

2021年8月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

TRACH-CHANGE

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?

いいえ

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

いいえ

米国FDA規制機器製品の研究

いいえ

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。

結果測定	メジャーの説明	時間枠
Age 時間枠：At ICU admission	Collected from electronic patient files.	At ICU admission
Weight 時間枠：At ICU admission	Collected from electronic patient files.	At ICU admission
Height 時間枠：At ICU admission	Collected from electronic patient files.	At ICU admission
Body mass index 時間枠：At ICU admission	Calculated from weight and height	At ICU admission
Predicted body weight (PBW) 時間枠：At ICU admission	Calculated as such : Adult male: 50 + 0.91 (Height cm -152.4) / Adult female: 45 + 0.91 (Height cm -152.4)	At ICU admission
SOFA score (admission) 時間枠：At ICU admission	Calculated at admission	At ICU admission
Clinical Frailty Score 時間枠：At ICU admission	Calculated at ICU admission	At ICU admission
Charlson comorbidity index 時間枠：At ICU admission	Calculated at ICU admission	At ICU admission
Comorbidities 時間枠：At ICU admission	Collected at ICU admission	At ICU admission
Ventilation modalities and settings from intubation to tracheotomy 時間枠：Once every day at 8am, between day after intubation to day before tracheotomy, up to 60 days	Ventilation modalities and settings recolted from electronic patient files.	Once every day at 8am, between day after intubation to day before tracheotomy, up to 60 days
Sedation opioid use from intubation to tracheotomy 時間枠：Once every day at 8am and at time of minimal and maximal value, between day of intubation to day of tracheotomy, up to 60 days	Sedation use collected from electronic patient files.	Once every day at 8am and at time of minimal and maximal value, between day of intubation to day of tracheotomy, up to 60 days
Opioid use from intubation to tracheotomy 時間枠：Once every day at 8am and at time of minimal and maximal value, between day of intubation to day of tracheotomy, up to 60 days	Opioid use collected from electronic patient files.	Once every day at 8am and at time of minimal and maximal value, between day of intubation to day of tracheotomy, up to 60 days
Neuromuscular blocking agent use from intubation to tracheotomy 時間枠：Once every day at 8am and at time of minimal and maximal value, between day of intubation to day of tracheotomy, up to 60 days	Neuromuscular blocking agent use collected from electronic patient files.	Once every day at 8am and at time of minimal and maximal value, between day of intubation to day of tracheotomy, up to 60 days
Tracheotomy time 時間枠：At time of tracheotomy, once, up to 60 days after intubation day	Collected from electronic patient files (day and hour)	At time of tracheotomy, once, up to 60 days after intubation day
Tracheotomy type (percutaneous, surgical) 時間枠：At time of tracheotomy, once, up to 60 days after intubation day	Collected from electronic patient files.	At time of tracheotomy, once, up to 60 days after intubation day
Ventilation settings and modalities from day of tracheotomy 時間枠：2 hours before tracheotomy	Collected from electronic patient files.	2 hours before tracheotomy
SOFA score (tracheotomy day) 時間枠：Once, on the day of tracheotomy (worst value of the day of tracheotomy), up to 60 days after intubation day	Calculated from electronic patient files.	Once, on the day of tracheotomy (worst value of the day of tracheotomy), up to 60 days after intubation day
Ventilation modalities and settings from tracheotomy to mechanical ventilation weaning 時間枠：Once per day, from day of tracheotomy to mechanical ventilation weaning, up to 60 days	Ventilation modalities and settings collected from electronic patient files.	Once per day, from day of tracheotomy to mechanical ventilation weaning, up to 60 days
Tracheotomy weaning strategies from tracheotomy to mechanical ventilation weaning 時間枠：Once every day at 8am and at time of minimal and maximal value, from day of tracheotomy to day of mechanical ventilation weaning, up to 31 days	Data collected from electronic patient files.	Once every day at 8am and at time of minimal and maximal value, from day of tracheotomy to day of mechanical ventilation weaning, up to 31 days
Physical therapy sessions from tracheotomy to mechanical ventilation weaning 時間枠：Once every day at 8am and at time of minimal and maximal value, from day of tracheotomy to day of mechanical ventilation weaning, up to 31 days	Data collected from electronic patient files.	Once every day at 8am and at time of minimal and maximal value, from day of tracheotomy to day of mechanical ventilation weaning, up to 31 days
Mechanical ventilation weaning day 時間枠：Once (day 3 in a row of less than 12 hours of mechanical ventilation), up to 31 days after tracheotomy day	Data collected from electronic patient files.	Once (day 3 in a row of less than 12 hours of mechanical ventilation), up to 31 days after tracheotomy day
SOFA score (mechanical ventilation weaning day) 時間枠：Once (3rd consecutive day with less than 12-h of mechanical ventilation), up to 31 days after tracheotomy day	Calcutated from electronic patient files.	Once (3rd consecutive day with less than 12-h of mechanical ventilation), up to 31 days after tracheotomy day
Ventilation modalities and settings from mechanical ventilation weaning day to decannulation or ICU discharge or death 時間枠：Once every day at 8am and at time of minimal and maximal value, from day of mechanical ventilation weaning to decannulation or ICU discharge or death, up to 31 days	Collected from electronic patient files.	Once every day at 8am and at time of minimal and maximal value, from day of mechanical ventilation weaning to decannulation or ICU discharge or death, up to 31 days
Physical therapy sessions from mechanical ventilation weaning day to decannulation or ICU discharge or death 時間枠：Once every day at 8am and at time of minimal and maximal value, from day of mechanical ventilation weaning to decannulation or ICU discharge or death, up to 31 days	Collected from electronic patient files.	Once every day at 8am and at time of minimal and maximal value, from day of mechanical ventilation weaning to decannulation or ICU discharge or death, up to 31 days
Hospital stay duration 時間枠：Once, between day of hospital admission to day of hospital discharge, up to 2 years	Collected from electronic patient files and discharge letters	Once, between day of hospital admission to day of hospital discharge, up to 2 years
Outcome and specific treatments in ICU 時間枠：Once, between day of hospital admission to day of hospital discharge, up to 2 years	Data recolted from electronic patient files	Once, between day of hospital admission to day of hospital discharge, up to 2 years
Correlation of ventilation settings and modalities and tracheotomy weaning strategies 時間枠：Once, between day of hospital admission to day of hospital discharge, up to 2 years	Collected from electronic patient files and discharge letters	Once, between day of hospital admission to day of hospital discharge, up to 2 years