Comparison of Non-Invasive Mean Arterial Blood Pressure Measurements at the Arm and Ankle During Elective Cesarean Delivery.

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorSt. Justine's Hospital

About this trial

This observational study aims to compare mean arterial pressure measurements obtained using an ankle blood pressure cuff with those obtained using a standard upper-arm cuff in pregnant individuals undergoing elective cesarean delivery under spinal anesthesia. The primary objective is to determine the level of agreement between the two measurement sites.The main question\[s\] it aims to answer \[is/are\]:

Demonstrate that the mean arterial pressure is similar between arm and ankle with the blood pressure cuff

Every participant will be their own control. (Measurements will be taken at both sites on every participant)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Women scheduled for elective cesarean under neuraxial anesthesia at CHU Sainte-Justine.

American Society of Anesthesiologists Physical Status I-III

Singleton pregnancy

Gestation ≥ 35 weeks

Disqualifiers

Cesarean planned under general anesthesia.

Multiple pregnancy

Prematurity < 35 weeks gestation

Major fetal anomalies

Trial population

The target population will be adult pregnant women scheduled for elective cesarean delivery at CHU Sainte-Justine.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Mean arterial pressure

    Device

    Mean arterial pressure will be taken on the arm and on the ankle from the same patient and compared.

Treatment groups

110 Participants
are divided into 1 treatment group
Group A: Cesarean delivery patients1 intervention

Trial outcomes

Primary outcomes

1

Comparison of mean arterial pressure taken by appropriately sized blood pressure cuffs between arm and ankle taken 5 min after birth.

Comparison of mean arterial pressure taken by appropriately sized blood pressure cuffs between arm and ankle taken 5 min after birth. This is to measure the outcome at a time point compatible with skin-to-skin for the mother-baby dyad.

Time frame
From enrollment (in the waiting room) to end of surgery

Secondary outcomes

1

Comparison in mean, systolic, diastolic arterial pressure taken by appropriately sized pressure cuffs between arm and ankle before neuraxial anesthesia, in the holding area.

Comparison in mean arterial pressure taken by appropriately sized pressure cuffs between arm and ankle before neuraxial anesthesia, in the holding area. This is is to compare the blood pressure before any intervention was made, and to observe it a difference already exists.

Time frame
From the waiting room to before neuraxial anesthesia
2

Comparison of mean, systolic, diastolic arterial pressure taken by appropriately sized blood pressure cuffs between arm and ankle taken 5 min after neuraxial anesthesia.

Comparison of mean, systolic, diastolic arterial pressure taken by appropriately sized blood pressure cuffs between arm and ankle taken 5 min after neuraxial anesthesia. This is to evaluate if the two measurements are comparable when under neuraxial anesthesia with a vasopressor infusion.

Time frame
5 min after neuraxial anesthesia
3

Comparison in mean, systolic, diastolic arterial pressure taken by appropriately sized pressure cuffs between arm and ankle 10, 15, 20 minutes after birth.

Comparison in mean, systolic, diastolic arterial pressure taken by appropriately sized pressure cuffs between arm and ankle 10, 15, 20 minutes after birth. This is to determine if the blood pressure is comparable between arm and ankle for several time points after birth.

Time frame
10, 15, 20 minutes after birth
4

Assess maternal comfort and ease of skin-to-skin application with each blood pressure cuff (on the ankle and on the arm)

Assess maternal comfort and ease of skin-to-skin application with each blood pressure cuff (on the ankle and on the arm) with a questionnaire containing these questions : 1. Did the arm BP cuff cause you discomfort or pain? 2. Did the ankle BP cuff cause you discomfort or pain? 3. Did the arm BP cuff limit your ability to hold your newborn as you wished? 4. Did the ankle BP cuff limit your ability to hold your newborn as you wished?

Time frame
From enrollment in the waiting room to end of surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

St. Justine's Hospital

Lead sponsor

Université de Montréal

Collaborator