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Haemodynamic Response to General Anaesthesia in Healthy Orthopaedic Patients (HRespToAS)

Primary Purpose

Hypotension

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
LiDCO rapid™ CNAP monitoring
Sponsored by
Chelsea and Westminster NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hypotension

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients included in the study were those aged 18-45 years undergoing elective lower limb arthroscopic procedures with an American Society of Anesthesiologists (ASA) Grade of I-II.

Exclusion Criteria:

  • Patients unable or unwilling to provide valid informed consent,
  • Patients undergoing regional anaesthesia,
  • Patients that have contraindications to the LiDCO rapid™ CNAP monitoring (cardiac arrhythmias, aortic regurgitation and digital ischaemia) and BIS monitoring (hypersensitivity to adhesive use) and refusal of surgical, anaesthetic or operating theatre team.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Standard Care

    LiDCO rapid™ CNAP monitoring

    Arm Description

    We will compare the standard monitored group of patients with the LiDCO rapid™ monitored group. The control group will compose of patients supervised in a standard way.

    Young, healthy adult patients (ASA I and II) undergoing elective orthopaedic surgery under general anaesthesia will be included in to this study. We will compare the standard monitored group of patients with the LiDCO rapid™ monitored group. We will use in the LiDCO rapid™ CNAP monitoring group, the continuous real time haemodynamic monitoring through non-invasive arterial pressure waveform. The monitor LiDCO rapid™ CNAP permits, through analysis the arterial blood pressure trace, to acquire information about CO, SVR, HR variability, SV and BIS.

    Outcomes

    Primary Outcome Measures

    Cardiac output (mls blood/ minute)

    Secondary Outcome Measures

    Depth of anaesthesia using Bispectral Index (BIS)

    Full Information

    First Posted
    May 10, 2016
    Last Updated
    July 12, 2016
    Sponsor
    Chelsea and Westminster NHS Foundation Trust
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02834000
    Brief Title
    Haemodynamic Response to General Anaesthesia in Healthy Orthopaedic Patients
    Acronym
    HRespToAS
    Official Title
    Haemodynamic Response to General Anaesthesia Induction in Elective Orthopaedic Surgery Patients Using Non-invasive Cardiovascular Monitoring
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2014 (undefined)
    Primary Completion Date
    November 2014 (Actual)
    Study Completion Date
    November 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Chelsea and Westminster NHS Foundation Trust

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Continuous cardiovascular monitoring as part of management of high-risk surgical patients is widely practiced, however its role in low-risk surgical patients is unclear. Detailed monitoring of cardiovascular parameters from pre-induction stage allows clinicians to individualise anaesthetic management in the perioperative period. The investigators' aim was to investigate haemodynamic and Bispectral Index (BIS) changes in healthy patients undergoing surgery following induction of anaesthesia with propofol using a continuous non-invasive blood pressure device (LiDCOrapid™).
    Detailed Description
    Recruitment Orthopaedic surgical teams, anaesthetists and theatre staff were made aware of the study that was being conducted at the investigators' institution. Prospective subjects that met the inclusion criteria were identified from the hospital operating theatre's database two weeks prior to surgery. A letter, which contained the study's objectives and methods, was sent out to all patients. Subsequently, a telephone call was made to patients one week before surgery to clarify any queries they had. Consent was obtained on the morning of surgery. All study participants provided written informed consent. Peri-operative monitoring LiDCO™ CNAP and BIS monitoring were attached prior to induction of anaesthesia in the anaesthetic room of the operating theatre. A standardised anaesthetic technique was used for every participant, consisting of propofol induction, sevoflurane maintenance to a target BIS (40-60) and opioid analgesia with fentanyl. Participants underwent positive pressure ventilation to a tidal volume of 8ml/kg. Measurements of the following variables were taken continuously from pre-induction to time of extubation: heart rate, mean arterial blood pressure, stroke volume, cardiac output, systemic vascular resistance and BIS. Data recorded up to 3 minutes following propofol injection was analysed to capture the post-induction period. Further measurements were taken in recovery room. The total quantity and type of fluids, drugs administered, time of tourniquet application and removal (if performed), and the duration of the operation were recorded.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypotension

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Standard Care
    Arm Type
    No Intervention
    Arm Description
    We will compare the standard monitored group of patients with the LiDCO rapid™ monitored group. The control group will compose of patients supervised in a standard way.
    Arm Title
    LiDCO rapid™ CNAP monitoring
    Arm Type
    Experimental
    Arm Description
    Young, healthy adult patients (ASA I and II) undergoing elective orthopaedic surgery under general anaesthesia will be included in to this study. We will compare the standard monitored group of patients with the LiDCO rapid™ monitored group. We will use in the LiDCO rapid™ CNAP monitoring group, the continuous real time haemodynamic monitoring through non-invasive arterial pressure waveform. The monitor LiDCO rapid™ CNAP permits, through analysis the arterial blood pressure trace, to acquire information about CO, SVR, HR variability, SV and BIS.
    Intervention Type
    Device
    Intervention Name(s)
    LiDCO rapid™ CNAP monitoring
    Other Intervention Name(s)
    http://www.lidco-ir.co.uk
    Intervention Description
    LiDCO rapid™ CNAP monitoring allows through analysis of the arterial blood pressure trace to acquire information about CO, HR variability, SVR, SV and BIS during general anaesthesia.
    Primary Outcome Measure Information:
    Title
    Cardiac output (mls blood/ minute)
    Time Frame
    From induction up to 3 minutes
    Secondary Outcome Measure Information:
    Title
    Depth of anaesthesia using Bispectral Index (BIS)
    Time Frame
    From induction up to 3 minutes

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients included in the study were those aged 18-45 years undergoing elective lower limb arthroscopic procedures with an American Society of Anesthesiologists (ASA) Grade of I-II. Exclusion Criteria: Patients unable or unwilling to provide valid informed consent, Patients undergoing regional anaesthesia, Patients that have contraindications to the LiDCO rapid™ CNAP monitoring (cardiac arrhythmias, aortic regurgitation and digital ischaemia) and BIS monitoring (hypersensitivity to adhesive use) and refusal of surgical, anaesthetic or operating theatre team.

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes

    Learn more about this trial

    Haemodynamic Response to General Anaesthesia in Healthy Orthopaedic Patients

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