Local Warming to Improve Pulse Oximetry Accuracy in Critically Ill Patients
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVastra Gotaland Region
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Protocolized Local Warming
Other interventionLocal 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.
Treatment groups
240 Participants
are divided into 2 treatment groupsGroup A: Protocolized Local WarmingExperimental treatment 1 intervention
Group B: Usual Care Without Protocolized WarmingNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
SpO2-SaO2 Bias at 15 Minutes
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.
Time frame
15 minutes after initiation of the randomized strategySecondary outcomes
1
SpO2-SaO2 Bias at 60 Minutes
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.
Time frame
60 minutes after initiation of the randomized strategy2
Proportion of SpO2 Measurements Within ±2 Percentage Points of SaO2
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.
Time frame
15 and 60 minutes after initiation of the randomized strategy3
Change in Finger Perfusion Index
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.
Time frame
Baseline and 15, 60, 120, and 240 minutes4
Difference Between Finger and Earlobe Perfusion Index Response
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.
Time frame
Baseline, 15 minutes, and 60 minutesOther outcomes
1
Treatment Effect on SpO2-SaO2 Bias According to Fitzpatrick Skin Phototype
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.
Time frame
15 minutes after initiation of the randomized strategy2
Device-Specific SpO2-SaO2 Bias at 15 Minutes
SpO2-SaO2 bias, defined as SpO2 minus SaO2 in percentage points, will be determined separately for each pulse oximetry system in participants enrolled in the single-center device-comparison substudy. Bias will be compared across devices and between randomized warming and control groups.
Time frame
Baseline and 15 minutes after initiation of the randomized strategy3
Change in Device-Specific SpO2-SaO2 Bias After Local Warming
The change in SpO2-SaO2 bias from baseline to 15 minutes will be calculated for each pulse oximetry system. The analysis will evaluate whether the change differs between devices and randomized treatment groups.
Time frame
Baseline to 15 minutes4
Accuracy of Forehead Versus Finger Pulse Oximetry
SpO2-SaO2 bias and absolute agreement will be compared between finger-based pulse oximetry systems and a non-warmed forehead pulse oximeter.
Time frame
Baseline and 15 minutes after initiation of the randomized strategySponsors and contacts
Click on the lead sponsor to view all of their trials.
Vastra Gotaland Region
Lead sponsor
North Älvsborg County Hospital, Trollhättan
Collaborator
Skaraborg Hospital
Collaborator
Kungälvs sjukhus
Collaborator
Source ClinicalTrials.gov
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