Ankle/Brachial Non-Invasive Blood Pressure Difference During General Anesthesia

Ankle/Brachial Non-Invasive Blood Pressure Difference During General Anesthesia: a Prospective Cohort Observational Study in Young Healthy Patients

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.

Study Overview

• Status: Completed
• Conditions: Surgery
• Intervention / Treatment: Device: Ankle Non-invasive Blood pressure measurement; Device: Arm Non-invasive Blood pressure measurement

• Study Type: Observational
• Enrollment (Actual): 25

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1020
    • CHU Brugmann

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 40 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
General anesthesia; Patient (15 to 40 years old) undergoing elective surgery requiring general anesthesia in supine position.	Device: Ankle Non-invasive Blood pressure measurement; Non-invasive blood pressure measured simultaneously at the arm (model IntelliVue M8105a MP5 Phillips, calibrated).; Device: Arm Non-invasive Blood pressure measurement; Non-invasive blood pressure measured simultaneously at the ankle (model IntelliVue M8105a MP5 Phillips, calibrated).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ankle Brachial non-invasive blood pressure difference - time point 1	Difference between the non-invasive blood pressure measured at the ankle and at the arm, before induction of anesthesia	1 day
Ankle Brachial non-invasive blood pressure difference - time point 2	Difference between the non-invasive blood pressure measured at the ankle and at the arm, after induction of anesthesia	1 day
Ankle Brachial non-invasive blood pressure difference - time point 3	Difference between the non-invasive blood pressure measured at the ankle and at the arm, after securing airway	1 day
Ankle Brachial non-invasive blood pressure difference - time point 4	Difference between the non-invasive blood pressure measured at the ankle and at the arm, at surgical incision	1 day
Ankle Brachial non-invasive blood pressure difference - time point 5	Difference between the non-invasive blood pressure measured at the ankle and at the arm, 10 minutes after surgical incision	1 day
Ankle Brachial non-invasive blood pressure difference - time point 6	Difference between the non-invasive blood pressure measured at the ankle and at the arm, at reversal of anesthesia	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain at the arm (yes/no)	Answer 'yes' or 'no' to the question 'pain at the arm' in postoperative period	1 day
Pain at the ankle (yes/no)	Answer 'yes' or 'no' to the question 'pain at the ankle' in postoperative period	1 day
Ankle Brachial NIBP difference variation	Determine if Ankle Brachial NIBP difference remains constant or varies during different intraoperative periods	1 day

Collaborators and Investigators

• Sponsor: Philippe VAN DER LINDEN
• Investigators: Principal Investigator: Sean Coeckelenbergh, MD, CHU Brugmann

Publications and helpful links

General Publications

• 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. Erratum In: Circulation. 2013 Jan 1;127(1):e264.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2018
• Primary Completion (Actual): September 5, 2018
• Study Completion (Actual): September 5, 2018

Study Registration Dates

• First Submitted: May 24, 2018
• First Submitted That Met QC Criteria: May 24, 2018
• First Posted (Actual): June 6, 2018

Study Record Updates

• Last Update Posted (Actual): September 12, 2018
• Last Update Submitted That Met QC Criteria: September 11, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: CHUB-ABI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No