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Completed

NCT Number: NCT03547401

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

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.

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Key information

Conditions

Surgery

Age range

15 year–40 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Brugmann

Brussels, 1020, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ankle Non-invasive Blood pressure measurement

Device

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

Arm Non-invasive Blood pressure measurement

Device

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Philippe VAN DER LINDEN

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jun 6, 2018
Registry last updated
Sep 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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