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Local Warming to Improve Pulse Oximetry Accuracy in Critically Ill Patients (PULSEWARM)

2026年8月24日 更新者：Carl Sjödin、Vastra Gotaland Region

Effect of Local Warming on Pulse Oximetry Accuracy in Critically Ill Patients With Low Peripheral Perfusion: A Multicenter Randomized Controlled Trial

Pulse oximeters are widely used in intensive care to continuously estimate the oxygen level in the blood. However, pulse oximeter measurements may be less accurate when blood flow to the fingers is poor, which is common in critically ill patients.

This study will investigate whether warming the hand and lower part of the forearm can improve the accuracy of pulse oximeter measurements in mechanically ventilated adult intensive care patients with low blood flow to the fingers.

Participants will be randomly assigned to either a local warming strategy or usual care without warming. In the warming group, the hand and lower forearm will be warmed for 15 minutes to a target temperature of 41-42°C. Pulse oximeter measurements will be compared with oxygen saturation measured from an arterial blood sample before and after the intervention.

The main objective is to determine whether local warming reduces the difference between pulse oximeter oxygen saturation (SpO₂) and arterial oxygen saturation (SaO₂) 15 minutes after the start of the assigned strategy. The study will also assess whether any improvement persists at 60 minutes, how peripheral blood flow changes during 4 hours of follow-up, whether repeat warming is effective when blood flow decreases again, and whether the effect differs according to skin phototype. Safety related to the warming intervention will also be evaluated.

調査の概要

状態

まだ募集していません

条件

介入・治療

詳細な説明

Pulse oximetry is a fundamental component of monitoring and oxygen titration in critically ill patients. Its accuracy may, however, be impaired by reduced peripheral perfusion. Low peripheral perfusion is common in mechanically ventilated intensive care patients and may contribute to clinically relevant differences between peripheral oxygen saturation measured by pulse oximetry (SpO₂) and arterial oxygen saturation measured by blood gas analysis (SaO₂).

Local warming increases cutaneous blood flow and is routinely used to improve peripheral perfusion during procedures such as capillary blood sampling. Preliminary single-center data suggest that local warming may also improve pulse oximetry accuracy in critically ill patients with low peripheral perfusion. Whether this effect is present when evaluated in a randomized controlled trial is unknown.

This is a prospective, multicenter, parallel-group randomized controlled strategy trial conducted in four intensive care units. Mechanically ventilated adult ICU patients with an arterial catheter and a finger perfusion index (PFI) <1.0 will be randomized in a 1:1 ratio to a protocolized local warming strategy or usual care without protocolized warming. Randomization will be stratified by study site and Fitzpatrick skin phototype.

In the intervention group, local warming will be applied to the dorsum of the hand and distal forearm for 15 minutes, with a target interface temperature of 41-42°C. Repeat warming is permitted during follow-up if finger PFI decreases below 0.5 according to the prespecified study strategy. The control group will receive usual care without protocolized local warming.

SpO₂, finger PFI, earlobe PFI, and arterial SaO₂ will be assessed at baseline, 15 minutes, and 60 minutes. Additional PFI measurements will be obtained at 120 and 240 minutes. Oxygen therapy will otherwise be managed according to standard clinical care.

The primary objective is to compare pulse oximetry bias between the randomized groups at 15 minutes. Bias is defined as SpO₂ minus SaO₂, expressed in percentage points. The primary analysis will compare the groups using an analysis of covariance adjusted for baseline SpO₂-SaO₂ bias and study site.

Secondary objectives include assessment of pulse oximetry accuracy at 60 minutes, the proportion of measurements within ±2 percentage points of SaO₂, changes in peripheral perfusion during 4 hours of follow-up, the local versus systemic perfusion response assessed using finger and earlobe PFI, the response to repeat warming, safety outcomes, and possible treatment-effect modification according to Fitzpatrick skin phototype.

The planned sample size is 240 participants, with 120 participants allocated to each study group.

研究の種類

介入

入学 (推定)

240

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。

研究連絡先

研究場所

  • スウェーデン
      • Gothenburg、スウェーデン
        • Sahlgrenska University Hospital
        • コンタクト：
      • Kungälv、スウェーデン
        • Kungälvs Sjukhus
      • Skövde、スウェーデン
        • Skaraborgs Sjukhus
      • Trollhättan、スウェーデン
        • Norra Älvsborgs Sjukhus

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

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

Inclusion Criteria:

  • Age 18 years or older.
  • Admitted to an intensive care unit.
  • Receiving invasive mechanical ventilation via endotracheal tube or tracheostomy.
  • Existing arterial catheter placed for a clinical indication.
  • Objectively verified low peripheral perfusion, defined as finger perfusion index (PFI) <1.0 at screening.
  • Stable baseline pulse oximetry signal permitting calculation of the SpO2-SaO2 difference.
  • Clinical condition considered sufficiently stable to allow study measurements without interfering with ongoing treatment.

Exclusion Criteria:

  • Absence of a stable baseline pulse oximetry signal on all available sensors, preventing calculation of the SpO2-SaO2 difference.
  • Skin injury, burn, infection, or other local skin condition of the hand or forearm that prevents safe application of the warming pad or pulse oximetry sensor.
  • Clinical instability for which the treating physician considers study participation likely to interfere with acute treatment or patient safety.
  • Known hypersensitivity to materials used in the warming pad or sensors.
  • Participation in another ongoing interventional study that could affect the primary outcome.

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：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：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
実験的：Protocolized Local Warming
Participants receive protocolized local warming applied to the dorsum of the hand and distal forearm for 15 minutes, targeting an interface temperature of 41-42°C. Repeat warming is permitted during follow-up if finger perfusion index decreases below 0.5.
他の：Protocolized Local Warming
Local warming is applied to the dorsum of the hand and distal forearm for 15 minutes using a warming device adjusted to achieve a target interface temperature of 41-42°C. During follow-up, repeat warming is permitted if finger perfusion index decreases below 0.5.
介入なし：Usual Care Without Protocolized Warming
Participants receive usual care without protocolized local warming. Oxygen therapy and all other clinical management are provided according to standard intensive care practice.

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
SpO2-SaO2 Bias at 15 Minutes
時間枠：15 minutes after initiation of the randomized strategy
Pulse oximetry bias is defined as peripheral oxygen saturation measured by pulse oximetry (SpO2) minus arterial oxygen saturation measured by blood gas analysis (SaO2), expressed in percentage points. The primary analysis will compare SpO2-SaO2 bias between the local warming and control groups at 15 minutes, adjusted for baseline bias and study site.
15 minutes after initiation of the randomized strategy

二次結果の測定

結果測定
メジャーの説明
時間枠
SpO2-SaO2 Bias at 60 Minutes
時間枠：60 minutes after initiation of the randomized strategy
Pulse oximetry bias is defined as SpO2 minus SaO2, expressed in percentage points. Bias at 60 minutes will be compared between randomized groups to evaluate durability of the effect of the warming strategy.
60 minutes after initiation of the randomized strategy
Proportion of SpO2 Measurements Within ±2 Percentage Points of SaO2
時間枠：15 and 60 minutes after initiation of the randomized strategy
The proportion of participants with an absolute difference between SpO2 and SaO2 of 2 percentage points or less will be determined at 15 and 60 minutes and compared between randomized groups.
15 and 60 minutes after initiation of the randomized strategy
Change in Finger Perfusion Index
時間枠：Baseline and 15, 60, 120, and 240 minutes
Finger perfusion index (PFI) will be measured serially to assess the peripheral perfusion response to the randomized strategy and its durability during 4 hours of follow-up.
Baseline and 15, 60, 120, and 240 minutes
Difference Between Finger and Earlobe Perfusion Index Response
時間枠：Baseline, 15 minutes, and 60 minutes
Changes in perfusion index measured at the finger and earlobe will be compared to assess whether the perfusion response to local warming is predominantly local rather than systemic.
Baseline, 15 minutes, and 60 minutes
Perfusion Index Response to Repeat Local Warming
時間枠：Up to 240 minutes after randomization
Among participants in the warming group who undergo repeat warming because finger PFI decreases below 0.5 during follow-up, the change in finger PFI following repeat warming will be assessed to evaluate repeatability of the perfusion response.
Up to 240 minutes after randomization
Warming-Related Adverse Events
時間枠：From initiation of the randomized strategy through 240 minutes
Number of participants experiencing adverse events considered related to local warming, including skin injury, erythema requiring discontinuation of warming, or other prespecified adverse reactions during the study period.
From initiation of the randomized strategy through 240 minutes

その他の成果指標

結果測定
メジャーの説明
時間枠
Treatment Effect on SpO2-SaO2 Bias According to Fitzpatrick Skin Phototype
時間枠：15 minutes after initiation of the randomized strategy
Prespecified analysis of treatment-effect modification according to Fitzpatrick skin phototype. The interaction between randomized treatment group and Fitzpatrick skin phototype will be evaluated for the primary outcome of SpO2-SaO2 bias at 15 minutes.
15 minutes after initiation of the randomized strategy

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

Vastra Gotaland Region

協力者

Skaraborg Hospital
North Älvsborg County Hospital, Trollhättan

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 (推定)

2026年10月1日

一次修了 (推定)

2028年10月1日

研究の完了 (推定)

2028年12月1日

試験登録日

最初に提出

2026年8月24日

QC基準を満たした最初の提出物

2026年8月24日

最初の投稿 (実際)

2026年8月28日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月28日

QC基準を満たした最後の更新が送信されました

2026年8月24日

最終確認日

2026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

  • PULSEWARM-RCT-01

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?

未定

IPD プランの説明

The feasibility and conditions for sharing de-identified individual participant data have not yet been determined. Any future data sharing will be subject to applicable ethical approvals, data protection regulations, institutional policies, and appropriate data-sharing agreements.

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