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Continuous Monitoring on the General Ward

2017年4月24日 更新者:Radboud University Medical Center

Continuous Monitoring of Vital Signs in Hospitalized Patients

Rationale: Monitoring patients' vital signs is done to detect clinical deterioration. For this, the MEWS, a scoring list comprising seven vital signs measured by nursing staff, is used. Although the MEWS provides relevant data on patients' health status, the interval measurements may not capture early deterioration of vital signs, especially during the night. As a result, unsafe situations may occur such as periods of low oxygen saturation and cardiac arrhythmias, which are known to complicate postoperative course. Besides, this way of measuring vital signs may be stressful for patients and disturbs patients' sleep. New technology such as ViSi Mobile and HealthPatch allows for remote continuous monitoring of vital signs using wearable devices transmitting relevant data to nurses and clinicians. With this, the investigators think that clinical deterioration may be detected in an early phase and reduce nurse work load and patient distress.

Objective: to investigate the feasibility of wearable devices on the general ward.

Study design: feasibility study.

Study population: adult patients hospitalized on the internal medicine ward and adult postoperative patients on the surgical ward.

Intervention: patients in the intervention groups will be randomized in one of the two groups. Patients in the group 1 will wear ViSi Mobile; patients in group 2 will wear the HealthPatch. Wearable devices will be worn for at least three days. Regular MEWS measurements take place at usual time points.

Main study parameters/endpoints: Evaluation with patient and care givers (primary outcome measure), MEWS calculations, time between alarm (continuous data) and next regular MEWS measurement (nurse), intervention by nurse after alarm, admission to ICU, complications, side effects of devices, STAI scores, and PCS scores will be documented.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients will wear one device for at least three days. Devices can be uncomfortable by being heavy or the patches can start itching. More measurements by nurses can take place when indicated, for example after alarms. The participating patients will fill out the STAI on daily basis and the PCS on the last day of hospitalization. Both questionnaires will take a few minutes to complete. Patients could benefit from early detection of clinical deterioration and early corrective interventions or ICU admissions.

調査の概要

研究の種類

介入

入学 (実際)

90

段階

  • 適用できない

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~85年 (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

説明

Inclusion Criteria:

  • Patient is 18 years or older on the day the informed consent will be signed.
  • Patient is hospitalized on the surgical or internal medicine ward.
  • MEWS measurements are required at least three times a day.
  • Patient is able to speak, read and understand the local language of the investigational site, is familiar with the procedures of the study, and agrees to participate in the study program by giving oral and written informed consent prior to screening evaluations.

Exclusion Criteria:

  • Frequency of MEWS measurements is less than three times a 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:防止
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • 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
介入なし:Control group
Patients with regular measurements by nurses only (Modified Early Warning Score (MEWS))
実験的:HealthPatch (Intervention)
Patients with HealthPatch and regular MEWS measurements
The HealthPatch (Vital Connect) is a wireless patch and continuously measures single-lead ECG, heart rate, respiratory rate, stress, skin temperature, body posture and steps
実験的:ViSi Mobile (Intervention)
Patients with ViSi Mobile and regular MEWS measurements
ViSi Mobile (Sotera Wireless) is wireless device that is able to continuously measure all important vital parameters: ECG, heart rate, oxygen saturation, blood pressure, respiratory rate and skin temperature.

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
Expectations & experiences of patients
時間枠:2-3 days after informed consent
Interviews of 15-20 minutes with patients after 2-3 days wearing a device or control group
2-3 days after informed consent
Expectations & experiences of care givers
時間枠:1 year
Interviews with nurses of 15-20 minutes at the end of the study. Estimated amount of 6 nurses
1 year

二次結果の測定

結果測定
メジャーの説明
時間枠
MEWS scores based on continuous data and data measured by nurses
時間枠:3 times a day, up to three days.
3 times a day, up to three days.
Amount of alarms by HealthPatch or ViSi Mobile
時間枠:during 2-3 days when the patient wears a device
during 2-3 days when the patient wears a device
Time between alarm (continuous data) and next regular MEWS measurement (nurse)
時間枠:during 2-3 days when the patient wears a device
during 2-3 days when the patient wears a device
Amount of extra MEWS measurements by nurses due to alarms
時間枠:during 2-3 days when the patient wears a device
during 2-3 days when the patient wears a device
Admission to ICU (yes/no)
時間枠:during 2-3 days when the patient participates in this study
during 2-3 days when the patient participates in this study
Duration of ICU hospitalization in days
時間枠:during 2-3 days when the patient participates in this study
during 2-3 days when the patient participates in this study
Complications caused by disease or surgical procedure
時間枠:during 2-3 days when the patient participates in this study
during 2-3 days when the patient participates in this study
Adverse events caused by devices
時間枠:during 2-3 days when the patient wears a device
E.g. Itch or redness
during 2-3 days when the patient wears a device
Technical failures of devices (artifacts: a period longer than 1 minute the device does not measure vital parameters)
時間枠:during 2-3 days when the patient wears a device
during 2-3 days when the patient wears a device
Outcomes of the State Trait Anxiety Inventory (STAI)
時間枠:Once a day during the 2-3 days the patient participantes in this study
Once a day during the 2-3 days the patient participantes in this study
Outcomes of the Pain Catastrophizing Scale (PCS)
時間枠:On day 2 or 3 when patients participates in the study
On day 2 or 3 when patients participates in the study
System usability Scale
時間枠:1 year
1 year

その他の成果指標

結果測定
メジャーの説明
時間枠
Gender
時間枠:On day 1 when patients participates in the study
Extraction from EHR
On day 1 when patients participates in the study
Age
時間枠:On day 1 when patients participates in the study
Extraction from EHR
On day 1 when patients participates in the study
Diagnosis
時間枠:On day 1 when patients participates in the study
Extraction from EHR
On day 1 when patients participates in the study
Performed surgical procedure
時間枠:On day 1 when patients participates in the study
Extraction from EHR
On day 1 when patients participates in the study

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。

捜査官

  • 主任研究者:Harry van Goor, MD, PhD, FRCS、Radboud University Medical Center

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。

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)

2015年4月1日

一次修了 (実際)

2016年8月1日

研究の完了 (実際)

2016年9月1日

試験登録日

最初に提出

2016年7月25日

QC基準を満たした最初の提出物

2016年10月13日

最初の投稿 (見積もり)

2016年10月14日

学習記録の更新

投稿された最後の更新 (実際)

2017年4月25日

QC基準を満たした最後の更新が送信されました

2017年4月24日

最終確認日

2016年7月1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?

いいえ

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