Evaluation of Non-invasive Blood Pressure Measured at the Ankle During Cesarean Delivery Compared to the Arm

NCT04199156 | Completed

• 1 other identifier: MS-269-2019
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

Spinal anesthesia-induced maternal hypotension during cesarean delivery is hazardous to the mother and the fetus. Prevention of the unfavorable outcomes of maternal hypotension includes various fluid and vasopressor protocols, and requires careful, frequent monitoring of blood pressure during the first 30 minutes after spinal block. Many clinicians set the blood pressure measurement intervals at 1- minute or 2-minutes intervals during the early period after spinal block. it had been reported that hypotension of duration less than 2 minutes is not harmful to the neonate; thus, the minimum inter-measurement intervals for blood pressure readings should be 2 minutes. This high frequency of blood pressure measurements commonly leads to patient dis-satisfaction due to pain as well as impairment of the interaction with the fetus after delivery. Moreover, the blood pressure measurement in the upper limbs could be affected by movement and shivering. Using the ankle for measurement of non-invasive blood pressure (NIBP) was previously evaluated in normal subjects, and was reported to be feasible; however, its normal range differed from the arm NIBP. Under spinal anesthesia, the lower limb of the mother is neither mobile, nor sensate. Thus, it was previously hypothesized that measurement of blood pressure at the ankle of the mother could improve patient comfort. Darke and Hill had evaluated the accuracy of non-invasive blood pressure at the arm and the ankle during cesarean delivery. Darke and Hill had reported that the degree of bias between the two sites is not acceptable; however, their study did not evaluate the accuracy of ankle NIBP as a trend monitor to trace the changes in maternal blood pressure. The aim of this work is to evaluate the accuracy and precision of ankle NIBP as a trend monitor in mothers undergoing cesarean delivery under spinal anesthesia.

Conditions

Non-invasive Blood Pressure; Cesarean Delivery; Spinal Anesthesia

Outcome Measures

Primary Outcomes (1)

• mean bias and agreement between ankle non-invasive blood pressure and arm non-invasive blood pressure

  mmHg

  intraoperative (every 2 minutes from injection of local anesthetic into subarachnoid space till 5 minutes after delivery, then every 5 minutes till the end of surgery)

Secondary Outcomes (5)

• The accuracy of ankle systolic blood pressure to diagnose arm absolute systolic hypotension

  intraoperative (every 2 minutes from injection of local anesthetic into subarachnoid space till 5 minutes after delivery, then every 5 minutes till the end of surgery)

• The accuracy of ankle systolic blood pressure to diagnose arm relative systolic hypotension

  intraoperative (every 2 minutes from injection of local anesthetic into subarachnoid space till 5 minutes after delivery, then every 5 minutes till the end of surgery)

• parturient comfort toward arm cuff and ankle cuff

  5 minutes after the surgery

• arm circumference

  5 minutes before the surgery

• ankle circumference

  5 minutes before the surgery

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

full term singleton pregnant women (18-35 years) scheduled for elective cesarean delivery under spinal anesthesia.

You may qualify if:

• full term singleton pregnant women (18-35 years) scheduled for elective cesarean delivery under spinal anesthesia.

You may not qualify if:

• Patients with coarctation of aorta,
• cardiac arrythmia,
• impaired cardiac contractility (ejection fraction\< 50%),
• congenital heart disease,
• moderate to severe valvular heart disease,
• uncontrolled hypertension,
• known peripheral vascular disease,
• peripartum bleeding,
• body mass index \> 35
• Condition which preclude placement of blood pressure cuff on either limb (lymphedema, high risk of developing lymphedema, local skin damage, known vascular stenotic lesion, deep venous thrombosis)

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Kasr Alaini Hospital

Cairo, 11562, Egypt

Location

Related Publications (1)

• Refaat S, Mostafa M, Hasanin A, Rujubali N, Fouad R, Hassabelnaby Y. Accuracy of noninvasive blood pressure measured at the ankle during cesarean delivery under spinal anesthesia. J Clin Monit Comput. 2021 Oct;35(5):1211-1218. doi: 10.1007/s10877-020-00583-y. Epub 2020 Aug 29.

  PMID: 32860553 DERIVED

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 12, 2019
• First Posted: December 13, 2019
• Study Start: January 1, 2020
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: September 1, 2021

Record last verified: 2021-08

Locations

EG (1)