Blood Isoflurane Concentration and the Oxygenator

NCT03146949 | Completed

• 1 other identifier: AC16130
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

This study compares two oxygenators commonly in use to establish whether they effect the amount of isoflurane in the patient's blood. Half of the patients will be placed in a group using the Sorin Inspire oxygenator and half into the group using the Medtronic Affinity Fusion oxygenator.

Conditions

Cardiopulmonary Bypass

Outcome Measures

Primary Outcomes (1)

• Arterial blood concentration of isoflurane

  6ml sample of blood will be taken at three time points during an operation requiring cardiopulmonary bypass. This blood will be analysed using gas chromatography and mass spectrometry in order to quantify isoflurane concentrations. Mean values will be calculated for each participant, and then an overall mean will be produced for each oxygenator. This will then be compared using independent-samples t-test.

  Application of aortic cross clamp, 20 minutes after application, removal of aortic cross clamp.

Secondary Outcomes (3)

• Change in Bispectral Index Score (BIS)

  Application of aortic cross clamp, 20 minutes after application, removal of aortic cross clamp.

• Change in arterial temperature

  Application of aortic cross clamp, 20 minutes after application, removal of aortic cross clamp.

• Change in exhaust isoflurane concentration

  Application of aortic cross clamp, 20 minutes after application, removal of aortic cross clamp.

Study Arms (2)

Sorin Inspire Oxygenator

ACTIVE COMPARATOR

Sorin Inspire Oxygenator is used on the cardiopulmonary bypass machine

Device: Sorin Inspire Oxygenator

Medtronic Affinity Fusion Oxygenator

ACTIVE COMPARATOR

Medtronic Affinity Fusion Oxygenator is used on the cardiopulmonary bypass machine

Device: Medtronic Affinity Fusion

Interventions

Sorin Inspire Oxygenator DEVICE

This is an oxygenator manufactured by the Sorin group. It is a hollow fibre polypropylene oxygenator.

Sorin Inspire Oxygenator

Medtronic Affinity Fusion DEVICE

This is an oxygenator manufactured by the Medtronic group. It is a hollow fibre polypropylene oxygenator.

Medtronic Affinity Fusion Oxygenator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged 18 years or older
• who have given their consent to participate
• scheduled for elective cardiac surgery requiring CPB

You may not qualify if:

• unwilling or unable to provide informed consent
• presenting for emergency surgery
• undergoing cardiac surgery without CPB
• in whom total intravenous anaesthesia (TIVA) is being used

Sponsors & Collaborators

• University of Edinburgh: lead
• NHS Lothian: collaborator

Study Sites (1)

Royal Infirmary Edinburgh

Edinburgh, EH16 4SA, United Kingdom

Location

Study Officials

• Peter Alston

  Honorary Clinical Senior Lecturer and Consultant Anaesthetist

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Primary outcome assessor is masked. The primary outcome involves the analysis of blood concentrations of isoflurane, and the laboratory will not be given information on allocation.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2017
• First Posted: May 10, 2017
• Study Start: January 5, 2017
• Primary Completion: April 26, 2017
• Study Completion: April 26, 2017
• Last Updated: May 23, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)