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Methods for the Measurement of Respiratory Rate

2016年3月23日 更新者:Niels Egholm Pedersen、Herlev Hospital

This study aims to investigate these research questions:

  1. Is there a difference in the results obtained, when respiratory rate is measured automatically by an electronic device (SensiumVitals® system, Sensium Healthcare) compared with a research assistant using a criterion standard approach?
  2. Is there a difference in the results obtained, when respiratory rate is measured automatically by an electronic device (SensiumVitals® system, Sensium Healthcare) compared with hospital staff's current clinical practice?

調査の概要

詳細な説明

Respiratory rate is among the first vital signs to change when a deterioration in patient conditions occurs, and that it is highly useful in identifying high-risk patients, patients in pain, risk of death in patients treated for myocardial infarctions and medical patients at risk of cardiac arrest.

Respiratory rate is one of the seven physiological parameters included in the Early Warning Score (EWS), an aggregated track- and trigger-system for risk-stratification of patients in hospital wards at risk of imminent clinical deterioration. EWS includes an escalation protocol, defining when it is necessary for the ward staff to call for assistance and when vital parameters should be measured again.

Manual measurement of respiratory rates is the standard in hospital wards in the Capital Region of Denmark. During the measurement of respiratory rate, patients ideally have to lie still and refrain from talking. This poses a difficulty in daily, clinical practice. Several studies in hospital wards both using and not using an EWS-system report that respiratory rate is often omitted when vital signs are measured.

Even if the respiratory rate is measured regularly, poor inter-observer agreement and reproducibility of measured respiratory rates have been found. Respiratory rates recorded by nurses have been reported to be generally higher than those measured by observers using a standardised approach.

The EWS currently in use is validated using measurements obtained by normal nursing practise. If there is an element of human influence on the measurement of respiratory rate, automation could affect the prognostic properties of EWS in an unpredictable way, even if the automatically measured respiratory rates more reliably reflect the patients' physiology than current clinical practise.

If a systematic difference between the recordings by staff and the electronic devices currently on the market exists, this could have an implication on the EWS scores and subsequently, escalation protocols for patients with elevated EWS could be affected. If this is the case, EWS might even have to be re-validated using machine-measured respiratory rates.

Thus, even as there could be a number of advantages of automating the measurements of respiratory rates in hospital wards, due considerations are required before ward staff's manual measurement of respiratory rate can be replaced by measurements obtained from electronic devices. The purpose of this study is to evaluate if there is a systematic difference in the respiratory rate measurements performed by an electronic device (SensiumVitals® system, Sensium Healthcare) compared with the measurements performed by a research assistant using a criterion standard approach and the ward staff's usual measurements.

研究の種類

介入

入学 (実際)

50

段階

  • 適用できない

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

      • Herlev、デンマーク、2730
        • Copenhagen Academy for Medical Education and Simulation and Medical-Short Time Ward, Herlev 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

説明

Inclusion Criteria:

  • Age 18 years or older.
  • Able and willing to give informed consent to participation in the study and necessary data collection.
  • Admitted to the general medical short-time ward and planned stay there at the time of inclusion greater than two hours.

Exclusion Criteria:

  • Wounds, burns or other conditions that prevent proper attachment of the measurement device, or where wearing the device might cause or increase discomfort from wearing the device.
  • Allergies to medical graded tape or ECG electrodes.
  • Patients with cardiac pacemaker or implanted defibrillator.
  • Any condition or situation preventing proper information, consent and enrolment.
  • Respiratory rate measurements by another device using impedance pneumography.

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:診断
  • 割り当て:なし
  • 介入モデル:単一グループの割り当て

武器と介入

参加者グループ / アーム
介入・治療
他の:Included patients
All included patients will have respiratory rates measured by a research assistant using a criterion standard approach, by the SensiumVitals device and by the ward staff.
The patients will have their respiratory rates, heart rates and temperature (axilla) measured continuously by the SensiumVitals patch.

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
Difference in respiratory rate recorded by the research assistant using a criterion standard approach and the SensiumVitals device
時間枠:24 Hours
After enrolment at the general, medical short-time ward a research assistant will measure the patient's respiratory rate using a criterion standard approach. The time of this measurement will be registered, and the corresponding measurement made by the SensiumVitals device will be extracted and used for the comparison. Reported with Bland-Altman plots.
24 Hours

二次結果の測定

結果測定
メジャーの説明
時間枠
Difference in respiratory rate recorded by the ward staff using standard clinical practice and the SensiumVitals device
時間枠:24 Hours
The ward staff's first measurement of respiratory rate after the patient is enrolled in the study at the general, medical short-time ward as registered in the electronic patient journal. The time of this measurement will be registered, and the corresponding measurement made by the SensiumVitals device will be extracted and used for the comparison. Reported with Bland-Altman plots.
24 Hours

その他の成果指標

結果測定
メジャーの説明
時間枠
Early Warning Score recorded by the research assistant
時間枠:24 Hours
Early Warning Score (point score) will be recorded using standard practice by the research assistant. Parameters included in the Early Warning Score: Peripheal arterial oxygen satuation (%), pulse (beats per minute), use of supplementary oxygen (liters per minute), systolic and diastolic blood pressure (mmHg), level of consciousness (AVPU-scale), temperature (degrees celcius) and pulse regularity (yes/no).
24 Hours
Early Warning Score recorded by the ward staff
時間枠:24 Hours
Early Warning Score (point score) recorded using standard practice by the ward staff. Early Warning Score consists of: Peripheal arterial oxygen satuation (%), pulse (beats per minute), use of supplementary oxygen (liters per minute), systolic and diastolic blood pressure (mmHg), level of consciousness (AVPU-scale) and temperature (degrees celcius).
24 Hours

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

捜査官

  • 主任研究者:Niels E Pedersen, MD、Copenhagen Academy for Medical Education and Simulation, Herlev Hospital, Center for HR, Capital Region of Denmark

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

2016年1月1日

一次修了 (実際)

2016年2月1日

研究の完了 (実際)

2016年2月1日

試験登録日

最初に提出

2016年1月11日

QC基準を満たした最初の提出物

2016年1月29日

最初の投稿 (見積もり)

2016年2月3日

学習記録の更新

投稿された最後の更新 (見積もり)

2016年3月24日

QC基準を満たした最後の更新が送信されました

2016年3月23日

最終確認日

2016年3月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • CAMES-16-001

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。

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