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

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03547401
• Other study ID #: CHUB-ABI
• Status: Completed
• Start date: August 1, 2018
• Est. completion date: September 5, 2018

Study information

• Verified date: September 2018
• Source: Brugmann University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: September 5, 2018
• Est. primary completion date: September 5, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Surgery

Intervention

Device:
• Ankle Non-invasive Blood pressure measurement
Non-invasive blood pressure measured simultaneously at the arm (model IntelliVue M8105a MP5 Phillips, calibrated).
• Arm Non-invasive Blood pressure measurement
Non-invasive blood pressure measured simultaneously at the ankle (model IntelliVue M8105a MP5 Phillips, calibrated).

Locations

Country	Name	City	State
Belgium	CHU Brugmann	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Philippe VAN DER LINDEN

Country where clinical trial is conducted

Belgium, 

References & Publications (3)

Aboyans V, Criqui MH, Abraham P, Allison MA, Creager MA, Diehm C, Fowkes FG, Hiatt WR, Jönsson 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. Review. Erratum in: Circulation. 2013 Jan 1;127(1):e264. — View 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. — View Citation

Wilkes JM, DiPalma JA. Brachial blood pressure monitoring versus ankle monitoring during colonoscopy. South Med J. 2004 Oct;97(10):939-41. — View Citation

Outcome

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