- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT01677234
Wrist NIBP During Elective Cesarean Delivery
Comparison of Arm and Forearm Blood Pressure During Elective Cesarean Delivery
Přehled studie
Postavení
Detailní popis
Upper arm non-invasive blood pressure (NIBP) measurement is the most commonly accepted method of blood pressure (BP) monitoring. During a cesarean delivery it may be challenging to obtain an accurate measurement from the automated devices in over 50% of the attempts due to arm movement.1 Patients may voluntarily move their arm, but more often neuraxial (spinal, epidural, combined spinal-epidural) anesthesia is known to induce shivering that causes the patient's arm to shake.2 To eliminate the effect of movement of the upper arm, NIBP has been tested on the leg because it is immobilized during neuraxial anesthesia. However, studies monitoring NIBP on an ankle or a calf were unable to accurately detect changes (increase or decrease) in blood pressure in patients undergoing a cesarean delivery.3,4 It seems clinically reasonable that in the case of a shivering patient, the forearm, with less muscle mass, would shake less and could be stabilized more easily than the upper arm (stabilizing the forearm is easily done by holding the patient's hand with a light pressure on the arm rest). Therefore, positioning an NIBP cuff on the forearm (near the wrist) may be useful to obtain an accurate blood pressure measurement in shivering patients.
Previous studies have found that forearm BP overestimates blood pressure measured at the upper arm in a variety of clinical settings and patient populations under static (patient at rest, not submitted to an intervention that might alter BP) circumstances.5-8 It is unknown whether this overestimation is clinically relevant when blood pressure change occurs rapidly, such as during a cesarean delivery. During neuraxial anesthesia for cesarean delivery, it is important for the anesthesiologist to know both absolute values and clinically significant changes in blood pressure to determine their treatment. The detection of dynamic changes in blood pressure (as when the patient is submitted to an intervention that might alter BP per se, e.g. neuraxial anesthesia) has been studied in obstetric patients. Nevertheless, either due to the location where the BP cuff was placed4 (as on the lower limb with interference of the aorto-caval compression) or to the technology used to measure blood pressure,9 (the penaz technology was not consistent with oscillometric technology in a previous study) the forearm blood pressure was not comparable to upper arm blood pressure when measured using an oscillometric monitor.
This study will compare the upper arm (the current gold-standard) and the forearm NIBP measurements in patients undergoing an elective cesarean delivery under subarachnoid anesthesia. We hypothesize that the forearm systolic BP measurement values will be within 10% (lower or higher) of the systolic BP values measured in the upper arm at the same time-points
Typ studie
Zápis (Aktuální)
Kontakty a umístění
Studijní místa
-
-
British Columbia
-
Vancouver, British Columbia, Kanada, V6H 3N1
- British Columbia's Women's Hospital
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
Inclusion Criteria:
- Healthy (American Society of Anesthesiologist's (ASA) physical status I or II) patients
- Having an elective cesarean delivery under spinal or combined spinal epidural anesthesia
- ≥19 years old
Exclusion Criteria:
- Contra-indication to neuraxial anesthesia
- General anesthesia for any reason prior to delivery of the baby
- Use of the epidural component (epidural top-up) of combined spinal epidural anesthesia (prior to delivery of the baby)
- History of cardiovascular disease, e.g. hypertension (either essential or pregnancy-induced)
- A difference of more than 10% between both upper arms and forearms in mean blood pressure measurement prior to surgery (see below)
- BMI >35kg/m2 (it is more difficult to ensure the cuff size is correct in these obese patients)
- Inability to read and understand English for the purpose of informed consent
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
---|
Pregnant women
Pregnant women undergoing a cesarean section
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Compare trends in NIBP measurements between the upper arm and forearm
Časové okno: 30 minutes
|
Measure NIBP at the upper arm and forearm simultaneously during surgery.
NIBP cuffs will be on opposite arms.
|
30 minutes
|
Sekundární výstupní opatření
Měření výsledku |
Časové okno |
---|---|
To estimate the accuracy of blood pressure measured on the forearm
Časové okno: 30 minutes
|
30 minutes
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Simon Massey, MD, University of British Columbia, BC Women's Hospital
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- H12-01797
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .