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

NCT03547401 | Completed

• 1 other identifier: CHUB-ABI
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 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.

Conditions

Surgery

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (3)

• Pain at the arm (yes/no)

  1 day

• Pain at the ankle (yes/no)

  1 day

• Ankle Brachial NIBP difference variation

  1 day

Study Arms (1)

General anesthesia

Patient (15 to 40 years old) undergoing elective surgery requiring general anesthesia in supine position.

Device: Ankle Non-invasive Blood pressure measurement; Device: Arm Non-invasive Blood pressure measurement

Interventions

Ankle Non-invasive Blood pressure measurement DEVICE

Non-invasive blood pressure measured simultaneously at the arm (model IntelliVue M8105a MP5 Phillips, calibrated).

General anesthesia

Arm Non-invasive Blood pressure measurement DEVICE

Non-invasive blood pressure measured simultaneously at the ankle (model IntelliVue M8105a MP5 Phillips, calibrated).

General anesthesia

Eligibility Criteria

• Age: 15 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Philippe VAN DER LINDEN: lead

Study Sites (1)

CHU Brugmann

Brussels, 1020, Belgium

Location

Related Publications (3)

• 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.

  PMID: 15558917 BACKGROUND

• 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.

  PMID: 23480469 BACKGROUND

• 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.

  PMID: 23159553 BACKGROUND

Study Officials

• Sean Coeckelenbergh, MD

  CHU Brugmann

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 24, 2018
• First Posted: June 6, 2018
• Study Start: August 1, 2018
• Primary Completion: September 5, 2018
• Study Completion: September 5, 2018
• Last Updated: September 12, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)