- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Contatti e Sedi
Contatto studio
- Nome: Burçin Alaçam
- Numero di telefono: +905465903851
- Email: burcin.ersoy90@gmail.com
Luoghi di studio
-
-
-
Sakarya, Turchia (Türkiye)
- Sakarya University-Anesthesiology and Reanimation Department
-
Contatto:
- Burçin Alaçam
- Numero di telefono: +905465903851
- Email: burcin.ersoy90@gmail.com
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Metodo di campionamento
Popolazione di studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
|
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.
|
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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in Pulse Wave Transit Time
Lasso di tempo: 20 minutes after infraclavicular block
|
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.
|
20 minutes after infraclavicular block
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Perfusion Index
Lasso di tempo: 20 minutes after infraclavicular block
|
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.
|
20 minutes after infraclavicular block
|
|
Skin Temperature
Lasso di tempo: 20 minutes after infraclavicular block
|
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.
|
20 minutes after infraclavicular block
|
|
oxygen saturation
Lasso di tempo: 20 minutes after infraclavicular block
|
Changes in peripheral oxygen saturation measured using pulse oximetry during the study period.
|
20 minutes after infraclavicular block
|
Collaboratori e investigatori
Sponsor
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- SAU-ANE-BA-04
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .