Haemodynamic Response to General Anaesthesia in Healthy Orthopaedic Patients

NCT02834000 | Completed DMC

• 1 other identifier: 14/WM/0179
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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™).

Conditions

Hypotension

Outcome Measures

Primary Outcomes (1)

• Cardiac output (mls blood/ minute)

  From induction up to 3 minutes

Secondary Outcomes (1)

• Depth of anaesthesia using Bispectral Index (BIS)

  From induction up to 3 minutes

Study Arms (2)

Standard Care

NO INTERVENTION

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.

LiDCO rapid™ CNAP monitoring

EXPERIMENTAL

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.

Device: LiDCO rapid™ CNAP monitoring

Interventions

LiDCO rapid™ CNAP monitoring DEVICE

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.

Also known as: http://www.lidco-ir.co.uk

LiDCO rapid™ CNAP monitoring

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chelsea and Westminster NHS Foundation Trust: lead

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant in Anaesthesia and Intensive Care Medicine, Honorary Senior Clinical Lecturer, Divisional Research Lead for Planned Care Surgery and Clinical Support

Study Record Dates

• First Submitted: May 10, 2016
• First Posted: July 15, 2016
• Study Start: June 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: July 15, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will share