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Clinical Trials/NCT03547401
NCT03547401CompletedNot Applicable

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

Philippe VAN DER LINDEN1 site in 1 country25 target enrollmentStarted: August 1, 2018Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
25
Locations
1
Primary Endpoint
Ankle Brachial non-invasive blood pressure difference - time point 5

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
15 Years to 40 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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

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

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

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

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

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

Secondary Outcomes

  • Pain at the arm (yes/no)(1 day)
  • Pain at the ankle (yes/no)(1 day)
  • Ankle Brachial NIBP difference variation(1 day)

Investigators

Sponsor
Philippe VAN DER LINDEN
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Philippe VAN DER LINDEN

Professor

Brugmann University Hospital

Study Sites (1)

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