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LF: Low Flow Anaesthesia

Sponsor
Jan Jakobsson (Other)
Overall Status
Terminated
CT.gov ID
NCT02013869
Collaborator
University of California, Irvine (Other)
40
Enrollment
1
Location
2
Arms
27
Duration (Months)
1.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: Flow-I
  • Device: Asys
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
We studied the time to reach a MAC value for two fifferent anaesthetic machines, Flow-i versus Aisys looking at the time to reach 1 MAC desfluraneWe studied the time to reach a MAC value for two fifferent anaesthetic machines, Flow-i versus Aisys looking at the time to reach 1 MAC desflurane
Masking:
Single (Investigator)
Primary Purpose:
Basic Science
Official Title:
Low Flow Anaesthesia; Cost-effectiveness of the Flow-I Anaesthesia Machine, a Comparison to Established Anaesthesia Delivery Unit
Study Start Date :
May 1, 2015
Actual Primary Completion Date :
Aug 1, 2017
Actual Study Completion Date :
Aug 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Flow-I

Wash in of desflurane in an anaesthesia machine without below

Device: Flow-I
Desflurane Dialed setting 18 %
Active Comparator: Asys

Wash in of desflurane in conventional anaesthesia machine Asys

Device: Asys
Desflurane dialed 18%

Outcome Measures

Primary Outcome Measures

  1. Time to reach 1.5 MAC (minimal alveolar concentration) Et [1 hour]

    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

Secondary Outcome Measures

  1. amount of inhaled agent consumed ml/min [5 hours]

    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.

  2. Postoperative Quality of Recovery [72 hours]

    Quality of recovery will be followed during the first 72 hours after anaesthesia

Other Outcome Measures

  1. Adequate anaesthesia [5 hours]

    Patients will be asked after end of anaesthesia if they have had any recall of intraoperative events

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

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

Exclusion Criteria:

ASA > 2 heart failure COPD

Contacts and Locations

Locations

Site City State Country Postal Code
1 Danderyds Hospital Stockholm Sweden

Sponsors and Collaborators

  • Jan Jakobsson
  • University of California, Irvine

Investigators

  • Principal Investigator: Jan g Jakobsson, MD, Karolinska Institutet

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jan Jakobsson, Adj Professor, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT02013869
Other Study ID Numbers:
  • 201301
  • JJ201301
First Posted:
Dec 17, 2013
Last Update Posted:
Dec 2, 2017
Last Verified:
Nov 1, 2017
Keywords provided by Jan Jakobsson, Adj Professor, Karolinska Institutet
fresh gas flow
quality of anaesthesia
minimal alveolar concentration

Study Results

No Results Posted as of Dec 2, 2017