Clinical trial NCT03547401: Ankle/Brachial Non-Invasive Blood Pressure Difference During General Anesthesia
Official title: Ankle/Brachial Non-Invasive Blood Pressure Difference During General Anesthesia: a Prospective Cohort Observational Study in Young Healthy Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgery
Lead sponsor: Brugmann University Hospital
Sponsor class: OTHER
First posted: 2018-06-06
Enrollment: 25
Sex: ALL
Minimum age (years): 15
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient undergoing elective surgery requiring general anesthesia in supine position. American Society of Anesthesiology (ASA) pysical status score 1.

Brief summary: Brachial non-invasive blood pressure (NIBP) monitoring is recommended as part of the American Society of Anesthesiology (ASA) basic monitoring package. Although brachial NIBP is often practical, some surgeries and patients may require NIBP measurement elsewhere (e.g. the ankle).

Several studies have shown that ankle NIBP overestimates brachial NIBP measurements. Algorithms have been proposed, based on correlation studies, to estimate brachial NIBP from ankle NIBP during general anesthesia and mechanical ventilation. These algorithms, however, are based on both heterogeneous populations and surgeries.

Our aim was to determine if ankle brachial NIBP difference occurs in in young ASA physical status 1 patients undergoing general anesthesia in the supine position. We also aim to determine if this difference is constant during anesthesia or if it varies according to different predefined time points.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiology (ASA) pysical status score 1
* Patient undergoing elective surgery requiring general anesthesia in supine position

Exclusion Criteria:

* Patient refusal
* systemic pathology
* Body mass index (BMI) superior to 30
* Surgeon requiring a position other than supine

Primary outcomes:
measure: Ankle Brachial non-invasive blood pressure difference - time point 1
timeFrame: 1 day
measure: Ankle Brachial non-invasive blood pressure difference - time point 2
timeFrame: 1 day
measure: Ankle Brachial non-invasive blood pressure difference - time point 3
timeFrame: 1 day
measure: Ankle Brachial non-invasive blood pressure difference - time point 4
timeFrame: 1 day
measure: Ankle Brachial non-invasive blood pressure difference - time point 5
timeFrame: 1 day
measure: Ankle Brachial non-invasive blood pressure difference - time point 6
timeFrame: 1 day
Secondary outcomes:
measure: Pain at the arm (yes/no)
timeFrame: 1 day
measure: Pain at the ankle (yes/no)
timeFrame: 1 day
measure: Ankle Brachial NIBP difference variation
timeFrame: 1 day
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: CHU Brugmann
Study officials:
affiliation: CHU Brugmann
name: Sean Coeckelenbergh, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wilkes JM, DiPalma JA. Brachial blood pressure monitoring versus ankle monitoring during colonoscopy. South Med J. 2004 Oct;97(10):939-41. doi: 10.1097/01.SMJ.0000129929.28792.77.
citation: Drake MJ, Hill JS. Observational study comparing non-invasive blood pressure measurement at the arm and ankle during caesarean section. Anaesthesia. 2013 May;68(5):461-6. doi: 10.1111/anae.12194. Epub 2013 Mar 11.
citation: Aboyans V, Criqui MH, Abraham P, Allison MA, Creager MA, Diehm C, Fowkes FG, Hiatt WR, Jonsson B, Lacroix P, Marin B, McDermott MM, Norgren L, Pande RL, Preux PM, Stoffers HE, Treat-Jacobson D; American Heart Association Council on Peripheral Vascular Disease; Council on Epidemiology and Prevention; Council on Clinical Cardiology; Council on Cardiovascular Nursing; Council on Cardiovascular Radiology and Intervention, and Council on Cardiovascular Surgery and Anesthesia. Measurement and interpretation of the ankle-brachial index: a scientific statement from the American Heart Association. Circulation. 2012 Dec 11;126(24):2890-909. doi: 10.1161/CIR.0b013e318276fbcb. Epub 2012 Nov 16. No abstract available.