Non-invasive Blood PressureNCT04199156
Evaluation of Non-invasive Blood Pressure Measured at the Ankle During Cesarean Delivery Compared to the Arm
An observational study of Non-invasive Blood Pressure and Cesarean Delivery, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Non-invasive Blood Pressure, Cesarean Delivery, Spinal Anesthesia
- How many people
- 42 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2020to 1 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Study population: full term singleton pregnant women (18-35 years) scheduled for elective cesarean delivery under spinal anesthesia.
Who may be able to join
- full term singleton pregnant women (18-35 years) scheduled for elective cesarean delivery under spinal anesthesia.
Who cannot join
- Patients with coarctation of aorta,
- cardiac arrythmia,
- impaired cardiac contractility (ejection fraction< 50%),
- congenital heart disease,
- moderate to severe valvular heart disease,
- uncontrolled hypertension,
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- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Non-invasive Blood Pressure Measured at the Ankle During Cesarean Delivery Compared to the Arm: a Prospective Observational Study
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.
Read the detailed description
In the preparation room, the parturient will relax in supine position with left uterine displacement by placing a wedge below the right hip. Appropriate size non-invasive blood pressure (NIBP) cuff for the arm and ankle will be chosen according to arm circumference just proximal to antecubital fossa and ankle circumference just above the malleoli, respectively. The cuff's bladder will be directed anteriorly in the arm and in posteriorly in the leg. Simultaneous NIBP measurement of both arms then both ankles will be done. The arm and the ankle with the higher reading will be used for intraoperative NIBP assessment. The baseline reading of the arm and ankle will be obtained as average of 3 reading 2 minutes apart. Simultaneous arm and ankle NIBP measurement will be 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. Left uterine displacement will be continued intraoperatively till the delivery. All NIBP measurements will be collected by a research assistant who have no role in parturient management.
Position of the parturient during the spinal anesthesia, drug dosage, fluid management and vasopressor administration will be according to local protocols and the discretion of the attending anesthetist. Intraoperative blood pressure management will be according to the arm NIBP readings
What is being measured
The primary outcome is the main question the study is designed to answer.
mean bias and agreement between ankle non-invasive blood pressure and arm non-invasive blood pressure
mmHg
Measured: 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
SBP <90 mmHg and < 100 mmHg
Measured: 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
20% reduction in arm systolic blood pressure
Measured: 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
0= painful, 1=discomfort, 2= comfortable
Measured: 5 minutes after the surgery
arm circumference
cm
Measured: 5 minutes before the surgery
ankle circumference
cm
Measured: 5 minutes before the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2019
- Study start1 Jan 2020
- Primary completion1 Mar 2020
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-invasive Blood PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maha Mostafa Ahmad, MD, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04199156
- Sponsor's protocol ID
- MS-269-2019
- Status last verified
- Aug 2021
- First submitted
- 12 Dec 2019
- Last updated
- 1 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 32860553
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Non-invasive Blood Pressure Measured at the Ankle During Cesarean Delivery Compared to the Arm: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT04199156
- Acronym / sponsor ID
- MS-269-2019
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 13 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In the preparation room, the parturient will relax in supine position with left uterine displacement by placing a wedge below the right hip. Appropriate size non-invasive blood pressure (NIBP) cuff for the arm and ankle will be chosen according to arm circumference just proximal to antecubital fossa and ankle circumference just above the malleoli, respectively. The cuff's bladder will be directed anteriorly in the arm and in posteriorly in the leg. Simultaneous NIBP measurement of both arms then both ankles will be done. The arm and the ankle with the higher reading will be used for intraoperative NIBP assessment. The baseline reading of the arm and ankle will be obtained as average of 3 reading 2 minutes apart. Simultaneous arm and ankle NIBP measurement will be 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. Left uterine displacement will be continued intraoperatively till the delivery. All NIBP measurements will be collected by a research assistant who have no role in parturient management.
Position of the parturient during the spinal anesthesia, drug dosage, fluid management and vasopressor administration will be according to local protocols and the discretion of the attending anesthetist. Intraoperative blood pressure management will be according to the arm NIBP readings
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- full term singleton pregnant women (18-35 years) scheduled for elective cesarean delivery under spinal anesthesia.
Key inclusion criteria (1 listed)
- full term singleton pregnant women (18-35 years) scheduled for elective cesarean delivery under spinal anesthesia.
Key exclusion criteria (10 listed)
- Patients with coarctation of aorta,
- cardiac arrythmia,
- impaired cardiac contractility (ejection fraction< 50%),
- congenital heart disease,
- moderate to severe valvular heart disease,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
mean bias and agreement between ankle non-invasive blood pressure and arm non-invasive blood pressure
Time frame: 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)
mmHg
5 secondary outcomes
The accuracy of ankle systolic blood pressure to diagnose arm absolute systolic hypotension
Time frame: 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
Time frame: 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
Time frame: 5 minutes after the surgery
arm circumference
Time frame: 5 minutes before the surgery
ankle circumference
Time frame: 5 minutes before the surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2021.
- Derived from this study: PubMed 32860553Refaat 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-invasive Blood Pressure and Cesarean Delivery, run by Kasr El Aini Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mean bias and agreement between ankle non-invasive blood pressure and arm non-invasive blood pressure (time frame: 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04199156, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2021.