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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.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (估计的)

240

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 瑞典
      • Gothenburg、瑞典
        • Sahlgrenska University Hospital
        • 接触：
      • Kungälv、瑞典
        • Kungälvs Sjukhus
      • Skövde、瑞典
        • Skaraborgs Sjukhus
      • Trollhättan、瑞典
        • Norra Älvsborgs Sjukhus

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：支持治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：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.
其他：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.
无干预：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.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
SpO2-SaO2 Bias at 15 Minutes
大体时间：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

次要结果测量

结果测量
措施说明
大体时间
SpO2-SaO2 Bias at 60 Minutes
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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

其他结果措施

结果测量
措施说明
大体时间
Treatment Effect on SpO2-SaO2 Bias According to Fitzpatrick Skin Phototype
大体时间：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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Vastra Gotaland Region

合作者

Skaraborg Hospital
North Älvsborg County Hospital, Trollhättan

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年10月1日

初级完成 (估计的)

2028年10月1日

研究完成 (估计的)

2028年12月1日

研究注册日期

首次提交

2026年8月24日

首先提交符合 QC 标准的

2026年8月24日

首次发布 (实际的)

2026年8月28日

研究记录更新

最后更新发布 (实际的)

2026年8月28日

上次提交的符合 QC 标准的更新

2026年8月24日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • PULSEWARM-RCT-01

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

IPD 计划说明

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.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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