Local Warming to Improve Pulse Oximetry Accuracy in Critically Ill Patients (PULSEWARM)
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.
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Carl Sjödin, PhD student
- Numer telefonu: 0707163277
- E-mail: carl.sjodin@vgregion.se
Lokalizacje studiów
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Gothenburg, Szwecja
- Sahlgrenska University Hospital
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Kontakt:
- Carl Sjödin, PhD student
- Numer telefonu: 0707163277
- E-mail: carl.sjodin@vgregion.se
-
Kungälv, Szwecja
- Kungälvs Sjukhus
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Skövde, Szwecja
- Skaraborgs Sjukhus
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Trollhättan, Szwecja
- Norra Älvsborgs Sjukhus
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie podtrzymujące
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: 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.
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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.
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Brak interwencji: 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.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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SpO2-SaO2 Bias at 15 Minutes
Ramy czasowe: 15 minutes after initiation of the randomized strategy
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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.
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15 minutes after initiation of the randomized strategy
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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SpO2-SaO2 Bias at 60 Minutes
Ramy czasowe: 60 minutes after initiation of the randomized strategy
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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.
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60 minutes after initiation of the randomized strategy
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Proportion of SpO2 Measurements Within ±2 Percentage Points of SaO2
Ramy czasowe: 15 and 60 minutes after initiation of the randomized strategy
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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.
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15 and 60 minutes after initiation of the randomized strategy
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Change in Finger Perfusion Index
Ramy czasowe: Baseline and 15, 60, 120, and 240 minutes
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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.
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Baseline and 15, 60, 120, and 240 minutes
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Difference Between Finger and Earlobe Perfusion Index Response
Ramy czasowe: Baseline, 15 minutes, and 60 minutes
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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.
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Baseline, 15 minutes, and 60 minutes
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Perfusion Index Response to Repeat Local Warming
Ramy czasowe: Up to 240 minutes after randomization
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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.
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Up to 240 minutes after randomization
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Warming-Related Adverse Events
Ramy czasowe: From initiation of the randomized strategy through 240 minutes
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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.
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From initiation of the randomized strategy through 240 minutes
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Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Treatment Effect on SpO2-SaO2 Bias According to Fitzpatrick Skin Phototype
Ramy czasowe: 15 minutes after initiation of the randomized strategy
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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.
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15 minutes after initiation of the randomized strategy
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Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- PULSEWARM-RCT-01
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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