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

NCT ID: NCT03547401

Last Updated: 2018-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-08-01

Study Completion Date

2018-09-05

Brief Summary

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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.

Detailed Description

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Conditions

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Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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General anesthesia

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

Ankle Non-invasive Blood pressure measurement

Intervention Type DEVICE

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

Arm Non-invasive Blood pressure measurement

Intervention Type DEVICE

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

Interventions

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Ankle Non-invasive Blood pressure measurement

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

Intervention Type DEVICE

Arm Non-invasive Blood pressure measurement

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Philippe VAN DER LINDEN

OTHER

Sponsor Role lead

Responsible Party

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Philippe VAN DER LINDEN

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Sean Coeckelenbergh, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Brugmann

Locations

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CHU Brugmann

Brussels, , Belgium

Site Status

Countries

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Belgium

References

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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.

Reference Type BACKGROUND
PMID: 15558917 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23480469 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23159553 (View on PubMed)

Other Identifiers

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CHUB-ABI

Identifier Type: -

Identifier Source: org_study_id

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