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

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ClinicalTrials.gov Identifier: NCT03547401
Recruitment Status : Completed
First Posted : June 6, 2018
Last Update Posted : September 12, 2018
Sponsor:
Information provided by (Responsible Party):
Philippe VAN DER LINDEN, Brugmann University Hospital

Study Description
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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.


Condition or disease Intervention/treatment
Surgery Device: Ankle Non-invasive Blood pressure measurement Device: Arm Non-invasive Blood pressure measurement

Study Design
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Study Type : Observational
Actual Enrollment : 25 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Ankle/Brachial Non-Invasive Blood Pressure Difference During General Anesthesia: a Prospective Cohort Observational Study in Young Healthy Patients
Actual Study Start Date : August 1, 2018
Actual Primary Completion Date : September 5, 2018
Actual Study Completion Date : September 5, 2018
Groups and Cohorts
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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).


Outcome Measures
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Primary Outcome Measures :
  1. Ankle Brachial non-invasive blood pressure difference - time point 1 [ Time Frame: 1 day ]
    Difference between the non-invasive blood pressure measured at the ankle and at the arm, before induction of anesthesia

  2. Ankle Brachial non-invasive blood pressure difference - time point 2 [ Time Frame: 1 day ]
    Difference between the non-invasive blood pressure measured at the ankle and at the arm, after induction of anesthesia

  3. Ankle Brachial non-invasive blood pressure difference - time point 3 [ Time Frame: 1 day ]
    Difference between the non-invasive blood pressure measured at the ankle and at the arm, after securing airway

  4. Ankle Brachial non-invasive blood pressure difference - time point 4 [ Time Frame: 1 day ]
    Difference between the non-invasive blood pressure measured at the ankle and at the arm, at surgical incision

  5. Ankle Brachial non-invasive blood pressure difference - time point 5 [ Time Frame: 1 day ]
    Difference between the non-invasive blood pressure measured at the ankle and at the arm, 10 minutes after surgical incision

  6. Ankle Brachial non-invasive blood pressure difference - time point 6 [ Time Frame: 1 day ]
    Difference between the non-invasive blood pressure measured at the ankle and at the arm, at reversal of anesthesia


Secondary Outcome Measures :
  1. Pain at the arm (yes/no) [ Time Frame: 1 day ]
    Answer 'yes' or 'no' to the question 'pain at the arm' in postoperative period

  2. Pain at the ankle (yes/no) [ Time Frame: 1 day ]
    Answer 'yes' or 'no' to the question 'pain at the ankle' in postoperative period

  3. Ankle Brachial NIBP difference variation [ Time Frame: 1 day ]
    Determine if Ankle Brachial NIBP difference remains constant or varies during different intraoperative periods


Eligibility Criteria
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Ages Eligible for Study:   15 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03547401


Locations
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Belgium
CHU Brugmann
Brussels, Belgium, 1020
Sponsors and Collaborators
Philippe VAN DER LINDEN
Investigators
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Principal Investigator: Sean Coeckelenbergh, MD CHU Brugmann
More Information
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Publications:

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Responsible Party: Philippe VAN DER LINDEN, Professor, Brugmann University Hospital
ClinicalTrials.gov Identifier: NCT03547401    
Other Study ID Numbers: CHUB-ABI
First Posted: June 6, 2018    Key Record Dates
Last Update Posted: September 12, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No