Low Flow Anaesthesia, is There a Difference Between 2 Modern Anaesthetic Machines Using Different Gas Reservoir (LF)

Low Flow Anaesthesia; Cost-effectiveness of the Flow-I Anaesthesia Machine, a Comparison to Established Anaesthesia Delivery Unit

To study the Flow-I breathing circle during low flow general anaesthesia, whether this non-below system has advantages reduced time to reach Et 1MAC (minimal alveolar concentration) and lower consumption of inhaled agent

Study Overview

• Status: Terminated
• Conditions: General Anaesthesia
• Intervention / Treatment: Device: Flow-I, a modern anaesthetic machine without a bag/below/gas reservoir for compression of insufflation gas; Device: Asys, a anaesthetic machine with a bag/bellow for compression of gas to be insufflated

Detailed Description

Assessing whether there are clinical differences in anaesthetic performance between standard anaesthesia workstation including a below and the new Flow-I device without a below

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden
    • Danderyds Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

ASA 1-2 patient 18 - 65 years scheduled for elective surgery

Exclusion Criteria:

ASA > 2 heart failure COPD

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Flow-I; Wash in of desflurane (SupraneR) in an anaesthesia machine without below, a new technique that do not have abag/reservoir that is compressed but pushes the gas into the patient. This technique uses far less of fresh gas volume. Thus lower anaesthetic gas will be consumed per hour. The primary outcome is the amount of anaesthetic consumed, the decrease in liquid desflurane (SupraneR) in the vaporiser of the ananesthetic machine. The vaporizer will be weighed before and after the anaesthetic to define the amount used.	Device: Flow-I, a modern anaesthetic machine without a bag/below/gas reservoir for compression of insufflation gas; Desflurane Dialed setting 18 % on the machine gas vaporized
Active Comparator: Asys; Wash in of desflurane (Suprane) in conventional anaesthesia machine Asys, with the anaesthesia machine Asys that has a bag/reservoir that is compressed for insufflation of gas into the patient, thus it is expected that more gas will be consumed per hour. The primary outcome is the amount of anaesthetic consumed, the decrease in liquid desflurane (SupraneR) in the vaporiser of the ananesthetic machine. The vaporizer will be weighed before and after the anaesthetic to define the amount used.	Device: Asys, a anaesthetic machine with a bag/bellow for compression of gas to be insufflated; Desflurane dialed 18% on the machine gas vaporized

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to reach 1.5 MAC (minimal alveolar concentration) Et	The time needed, seconds, to increase the end tidal desflurane concentration during wash-in from a 1 MAC to a 1.5 MAC with a constant fresh gas flow of 1 L/min and the vaporiser set a 3 MAC ( minimal alveolar concentration) (18%) will be compared between the two study groups	1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
amount of inhaled agent consumed ml/min	The vaporiser will be weighed before and after each case and the amount of vapor, desflurane, consumed during the anaesthesia will be calculated Gr/min.	5 hours
Postoperative Quality of Recovery	Quality of recovery will be followed during the first 72 hours after anaesthesia	72 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adequate anaesthesia	Patients will be asked after end of anaesthesia if they have had any recall of intraoperative events	5 hours

Collaborators and Investigators

• Sponsor: Jan Jakobsson
• Collaborators: University of California, Irvine
• Investigators: Principal Investigator: Jan g Jakobsson, MD, Karolinska Institutet

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): August 1, 2017

Study Registration Dates

• First Submitted: November 29, 2013
• First Submitted That Met QC Criteria: December 11, 2013
• First Posted (Estimated): December 17, 2013

Study Record Updates

• Last Update Posted (Actual): March 19, 2024
• Last Update Submitted That Met QC Criteria: March 16, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: minimal alveolar concentration; fresh gas flow; quality of anaesthesia
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: 201301; JJ201301 (Other Grant/Funding Number: M201301)