- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07669688
Pulse Wave Transit Time After Infraclavicular Block
Time-Dependent Changes in Pulse Wave Transit Time Following Infraclavicular Block: A Non-Invasive Assessment of Sympathetic Blockade
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
Regional anesthesia success is traditionally assessed using sensory and motor block evaluation methods that rely on patient cooperation and subjective responses to external stimuli. However, these methods may be difficult to apply in sedated, uncooperative, or communication-impaired patients. Therefore, objective and non-invasive indicators of sympathetic blockade have gained increasing interest in regional anesthesia practice.
Pulse Wave Transit Time (PWTT) is defined as the time interval between the R-wave on the electrocardiogram and the arrival of the corresponding pulse wave detected by a peripheral pulse oximeter. PWTT reflects vascular tone, arterial compliance, and hemodynamic status. Sympathetic blockade induced by peripheral nerve blocks results in vasodilation and reduced vascular resistance, potentially leading to measurable changes in PWTT. Previous studies have demonstrated the utility of objective parameters such as perfusion index, skin temperature, blood flow measurements, and PWTT in assessing block success. However, data regarding the temporal changes of PWTT following infraclavicular brachial plexus block remain limited.
The primary objective of this prospective observational study is to investigate the time-dependent changes in PWTT after ultrasound-guided infraclavicular brachial plexus block. The study will be conducted in patients undergoing upper extremity surgery under infraclavicular block at Sakarya Training and Research Hospital.
Patients scheduled to receive infraclavicular block as part of their routine clinical care will be enrolled after providing informed consent. The block procedure is not performed for research purposes and represents standard clinical practice. Following block administration, PWTT values will be recorded from the blocked extremity using standard monitoring equipment. Measurements will be obtained before block placement and at 0, 5, 10, 15, and 20 minutes after block completion. Baseline PWTT measurements will also be obtained from the contralateral upper extremity.
Secondary outcome measures will include perfusion index, skin temperature of both upper extremities, heart rate, non-invasive blood pressure, respiratory rate, and oxygen saturation. Demographic and clinical data will also be recorded.
All measurements will be collected according to a predefined protocol using standardized monitoring equipment. Since PWTT is an objective device-derived parameter, observer dependency is expected to be minimal. Data collection personnel will be separated from the clinician performing the block whenever feasible to reduce measurement bias. All collected data will be anonymized prior to statistical analysis.
This study is designed as a single-center, prospective observational investigation without randomization or intervention beyond routine clinical care. The findings may contribute to the development of PWTT as a practical, objective, and non-invasive marker of sympathetic blockade following infraclavicular brachial plexus block.
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Burçin Alaçam
- Telefonní číslo: +905465903851
- E-mail: burcin.ersoy90@gmail.com
Studijní místa
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Sakarya, Turecko (Türkiye)
- Sakarya University-Anesthesiology and Reanimation Department
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Kontakt:
- Burçin Alaçam
- Telefonní číslo: +905465903851
- E-mail: burcin.ersoy90@gmail.com
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Metoda odběru vzorků
Studijní populace
Popis
Inclusion Criteria:
- Patients undergoing elective upper extremity hand surgery
- 18 - 65 years
- ASA I
- No coagulopathy, thrombocytopenia, coagulation disorders
- Patients who provide informed consent to participate in the study
Exclusion Criteria:
- History of drug allergy relevant to study procedures or local anesthetics
- Body mass index (BMI) ≥ 30 kg/m²
- Body weight < 40 kg
- Age < 18 years or > 65 years
- History of significant cardiac disease (e.g., arrhythmia, conduction abnormalities)
- Coagulopathy (INR > 1.5 or platelet count < 100,000/mm³)
- Pregnancy or lactation
- Infection at the site of peripheral nerve block
- ASA II-IV
- Failed block or motor block duration exceeding 30 minutes
- Patients reporting pain (NRS ≥ 3), due to potential influence on sympathetic activity
- Chronic opioid use
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
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Infraclavicular Block Group
Patients undergoing routine ultrasound-guided infraclavicular brachial plexus block for upper extremity surgery will be included in this observational cohort.
Pulse Wave Transit Time (PWTT) and other hemodynamic parameters will be measured at predefined time points before and after block administration.
No additional intervention beyond standard clinical care will be performed for research purposes.
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Ultrasound-guided infraclavicular brachial plexus block will be performed as part of routine clinical anesthesia practice for upper extremity surgery.
Local anesthetic will be administered according to standard institutional protocols.
No additional or experimental drug or procedure will be applied for research purposes.
Pulse Wave Transit Time (PWTT) and other hemodynamic parameters will be recorded before and after block placement at predefined time intervals.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in Pulse Wave Transit Time
Časové okno: 20 minutes after infraclavicular block
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The primary outcome is the time-dependent change in Pulse Wave Transit Time (PWTT) following ultrasound-guided infraclavicular brachial plexus block.
PWTT will be measured as the interval between the R-wave of the electrocardiogram (ECG) and the corresponding pulse wave detected by peripheral pulse oximetry.
Measurements will be recorded at baseline (pre-block) and at 0, 5, 10, 15, and 20 minutes after block placement.
The primary analysis will evaluate the change in PWTT over time within the blocked extremity.
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20 minutes after infraclavicular block
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Perfusion Index
Časové okno: 20 minutes after infraclavicular block
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Changes in perfusion index (PI) measured from the pulse oximeter at the blocked and contralateral upper extremities at baseline and at 0, 5, 10, 15, and 20 minutes after infraclavicular block.
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20 minutes after infraclavicular block
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Skin Temperature
Časové okno: 20 minutes after infraclavicular block
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Changes in skin temperature of the blocked and contralateral upper extremities measured at baseline and at 0, 5, 10, 15, and 20 minutes after block placement.
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20 minutes after infraclavicular block
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oxygen saturation
Časové okno: 20 minutes after infraclavicular block
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Changes in peripheral oxygen saturation measured using pulse oximetry during the study period.
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20 minutes after infraclavicular block
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Spolupracovníci a vyšetřovatelé
Sponzor
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
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