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- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01677234
Wrist NIBP During Elective Cesarean Delivery
Comparison of Arm and Forearm Blood Pressure During Elective Cesarean Delivery
Panoramica dello studio
Stato
Descrizione dettagliata
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
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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British Columbia
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Vancouver, British Columbia, Canada, V6H 3N1
- British Columbia's Women's Hospital
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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Pregnant women
Pregnant women undergoing a cesarean section
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Compare trends in NIBP measurements between the upper arm and forearm
Lasso di tempo: 30 minutes
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Measure NIBP at the upper arm and forearm simultaneously during surgery.
NIBP cuffs will be on opposite arms.
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30 minutes
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
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To estimate the accuracy of blood pressure measured on the forearm
Lasso di tempo: 30 minutes
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30 minutes
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Simon Massey, MD, University of British Columbia, BC Women's Hospital
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Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
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
- H12-01797
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 .